July 12, 2008
 

Radiology and Children: Extra Care Required


Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children.

Pet Food Products Seized at PETCO Distribution Center
Consumers who bought animal food products from PETCO in 16 states should take certain precautions

Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information.

Drug Shortage: MVI Adult Injectable
Hospira information updated.

Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage.

FDA 101: How to Use the Consumer Complaint System and MedWatch
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems.

Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product.

FDA 101: Biological Products
Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

 

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs


FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx
FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ...

Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad.

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

FDA 101: Biological Products
Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies.

Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm...

FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

 

Myfortic (mycophenolate acid)


Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Product recalled due to the presence of Burkholderia cepacia.

April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24)
The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary.

Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products.

Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)
Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected.

 

Rize 2 The Occasion Capsules and Rose 4 Her Capsules


Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient.

Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.

Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary.

July 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

March 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Heartworm Prevention in Your Pet
A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program.

FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007.

FDA 101: How to Use the Consumer Complaint System and MedWatch
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems.

 

New Medical Products: New Skin Graft Adhesive Approved


New Medical Products: New Skin Graft Adhesive Approved
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi...

Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx
FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ...

 

Beware of Online Cancer Fraud


Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice.

 

Is dental mercury a threat to health? - Baltimore Sun


Is dental mercury a threat to health? - Baltimore Sun
I was disturbed by the way The Sun 's article on dental amalgam portrayed this restorative material ("Fighting Tooth and Nail," July 3). The article mentioned that there is little scientific evidence to support Moms Against Mercury's claims about the
Source: www.baltimoresun.com

US, Europe, Australia unite on drug inspections - FOX News
WASHINGTON — Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications. Bush
Source: www.foxnews.com

UPDATE: FDA Panel Rejects Tough Warnings For Epilepsy Drugs - CNN Money
BELTSVILLE, Md. -(Dow Jones)- A Food and Drug Administration panel on Thursday did not recommend adding the agency's toughest warnings to labels of epilepsy drugs, saying studies didn't show a high enough risk for suicidal behavior. The move could be
Source: money.cnn.com

Salmonella found in basil grown in Mexico - Los Angeles Times
Salmonella, the bacterium that has sickened more than 1,000 Americans who ate tainted produce since April, has also been found in Thai basil grown in Mexico. The U.S. Food and Drug Administration identified salmonella during random testing of basil
Source: www.latimes.com

 

Pfizer argues against epilepsy drug warning - Reuters


Pfizer argues against epilepsy drug warning - Reuters
BELTSVILLE, Maryland (Reuters) - Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications, despite concerns from U.S. health regulators. The
Source: www.reuters.com

Waging the water-bottle battle - Seattle Times
Activists, governments and the bottled-water industry have engaged in a giant water fight for the past two years, extensively reported by the media. By now, many consumers know that the mass marketing of water in single-use bottles has environmental
Source: seattletimes.nwsource.com

Salmonella found in basil from Mexico - Boston Globe
WASHINGTON - A strain of salmonella, the bacteria that has sickened more than 1,000 Americans who ate tainted produce since April, has been found in Thai basil grown in Mexico. The Food and Drug Administration identified salmonella during random
Source: www.boston.com

Study Links Epilepsy Drug To Suicidal Thoughts - NPR News
Morning Edition , July 10, 2008 · The Food and Drug Administration is considering beefing up its warnings about the relationship between anti-epileptic drugs and suicide. Its staffers have analyzed 199 studies and found that the drugs increase the
Source: www.npr.org

 

Lake Country Lamb Feed Voluntary Recall (June 6)


Lake Country Lamb Feed Voluntary Recall (June 6)
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper.

How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24)
The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund.

Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product.

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9)
Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk
LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Heartworm Prevention in Your Pet
A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program.

Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information.

 

Stay Healthy While Traveling Abroad


Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad.

Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27)
The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products.

Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

Red Tomato Warning Expanded Nationwide
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

Heartworm Prevention in Your Pet
A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program.

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

July 11, 2008
 

Patients Sue N.J. Maker of Recalled Heart Drug - Law.com


Patients Sue N.J. Maker of Recalled Heart Drug - Law.com
The maker of recalled heart drug Digitek faces at least nine federal lawsuits in New Jersey, including one where a patient died, alleging the drug was dangerous and defective. The lawsuits were filed in U.S. District Court in Newark in recent months
Source: www.law.com

Cipro, similar antibiotics to get 'black box' warning - Wave 3
WASHINGTON (AP) - Drug safety officials are calling for an urgent safety warning for Cipro and similar antibiotics. The Food and Drug Administration is ordering the "black box" wording due to evidence the drugs may lead to tendon ruptures. They say
Source: www.wave3.com

Mexico says tests found no salmonella in Mexican tomatoes - Dallas Morning News
MEXICO CITY – Mexico's Agriculture Department says its tests found no salmonella in Mexican tomatoes. It says Mexican officials took samples from the same soil, water and tomatoes recently examined by U.S. inspectors and found no evidence of the
Source: www.dallasnews.com

Pfizer argues against epilepsy drug warning - Reuters
BELTSVILLE, Maryland (Reuters) - Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications, despite concerns from U.S. health regulators. The
Source: www.reuters.com

Seizure drugs won't get strong warning - Baltimore Sun
WASHINGTON Drugs used to treat epileptic seizures can raise suicide risks, but not enough to deserve the strongest warning labels available, a government panel of experts said yesterday. Advisers to the Food and Drug Administration voted 14-4 against
Source: www.baltimoresun.com

Intel gets FDA clearance on in-home medical device - Boston Globe
SANTA CLARA, Calif.— Chip maker Intel Corp. said Thursday it received market clearance from the U.S. Food and Drug Administration for its in-home personal health system. The Intel Health Guide is a care management tool for health care professionals
Source: www.boston.com

Mexico finds no salmonella in tomatoes - Salon
It says Mexican officials took samples from the same soil, water and tomatoes recently examined by U.S. inspectors and found no evidence of the bacteria. A team of inspectors from the U.S. Food and Drug Administration visited five Mexican farms in
Source: www.salon.com

Butkus says 'roid use in football embarrassing - NBC Sports
Hall of Famer Dick Butkus, center, who spoke to more than 200 students at a Soldier Field rally on Friday, on steroids: "I owe everything to football. I'm embarrassed that for some other kid, it won't be as pure as when I was able to play.'' CHICAGO
Source: nbcsports.msnbc.com

Salmonella found in basil from Mexico - Boston Globe
WASHINGTON - A strain of salmonella, the bacteria that has sickened more than 1,000 Americans who ate tainted produce since April, has been found in Thai basil grown in Mexico. The Food and Drug Administration identified salmonella during random
Source: www.boston.com

 

Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial


Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial
Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial

Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk
LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient.

Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information.

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.

 

Radiology and Children: Extra Care Required


Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children.

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.

New Medical Products: New Skin Graft Adhesive Approved
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi...

Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx
FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ...

Drug Shortage: Digitek (digoxin tablets, USP)
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website.

Your Guide to Reporting Problems to FDA
This guide provides tips and a quick-reference chart to help you report a problem to FDA.

Wrinkle Relief: Injectable Cosmetic Fillers
Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done.

FDA 101: How to Use the Consumer Complaint System and MedWatch
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems.

Important Information about Albuterol Metered Dose Inhalers (MDIs)
After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information)

Red Tomato Warning Expanded Nationwide
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes.

 

Science New "Cheerful" Intel Home Health Device Wins FDA Approval - DailyTech


Science New "Cheerful" Intel Home Health Device Wins FDA Approval - DailyTech
Intel is known best for its microprocessors , as it currently owns around 80 to 90 percent of the market . However, the company has made efforts to diversify into graphics and even more exotic offerings. Around the lines of its more unique offerings
Source: www.dailytech.com

FDA OKs In-Home Medical Device for Management of Health Conditions - HULIQ.com
Intel Receives FDA Market Clearance on In-Home Medical Device for Management of Health Conditions. The Intel® Health Guide Connects Patients and Their Care Teams for Personalized Care Management at Home. SANTA CLARA, Calif., July 10, 2008 – Intel
Source: www.huliq.com

FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs - Atlanta Journal Constitution
THURSDAY, July 10 (HealthDay News) -- Anti-seizure drugs can cause increased suicidal tendencies in patients, but not enough to warrant the government's strongest warning label on them, a U.S. health advisory panel concluded Thursday. The 20-member
Source: www.ajc.com

AngioDynamics issues product recall pending FDA review - MSN MoneyCentral
AngioDynamics, Inc. is voluntarily recalling all hospital inventory of Centros, a catheter used in dialysis. The Queensbury, N.Y.-based medical device manufacturer said it became aware that the catheter cuff, a component intended to anchor the
Source: news.moneycentral.msn.com

FDA Approves Intel's Home Health Monitoring System - eMaxHealth.com
FDA approved a new home health monitoring device from Intel. It is called Health Guide. This home health monitoring device is easy to use and aimed at helping those with chronic health conditions, who need to monitor health regularly. Intel's Home
Source: www.emaxhealth.com

FDA Panel: No Black Box Warning for Epilepsy Drugs - Wired
An FDA advisory panel has recommended against putting "black box" warnings on epilepsy drugs linked to a small increased risk of suicide . Though the panel's 14-4 vote is not binding, it will likely be heeded by the FDA. Doctors will, however, be
Source: blog.wired.com

FDA Told to Skip ‘Black Box’ on Epilepsy Drugs and Suicide - Wall Street Journal
Until yesterday, the FDA had been rolling steadily toward slapping a black-box warning on epilepsy drugs because they may increase the risk of suicidal thoughts and behaviors. But a committee of outside experts convened by the FDA thinks that’s a
Source: blogs.wsj.com

Diabetes linked to male infertility - United Press International
Insulin resistance ups breast cancer risk U.S. diabetes up 3 million in two years Vitamins may help diabetic memory slumps FDA may change rules for diabetes drugs Possible cause of late-onset disease found Diabetic dietary adherence effective
Source: www.upi.com

 

Epilepsy Drugs May Avoid Black Box - Wall Street Journal


Epilepsy Drugs May Avoid Black Box - Wall Street Journal
BELTSVILLE, Md. -- A Food and Drug Administration panel has recommended against adding the agency's toughest warnings to labels of epilepsy drugs, saying studies didn't show a high-enough risk for suicidal behavior to warrant such warnings. The move
Source: online.wsj.com

Seizure drugs won't get strong warning - Baltimore Sun
WASHINGTON Drugs used to treat epileptic seizures can raise suicide risks, but not enough to deserve the strongest warning labels available, a government panel of experts said yesterday. Advisers to the Food and Drug Administration voted 14-4 against
Source: www.baltimoresun.com

 

Salmonella probe puzzles investigators - Detroit Free Press


Salmonella probe puzzles investigators - Detroit Free Press
Jalapeno pepper producers are being probed alongside tomato distributors, and fresh cilantro also is under suspicion in what's become the nation's largest food-borne outbreak in at least a decade.
Source: www.freep.com

 

Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)


Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information.

How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

Important Information about Albuterol Metered Dose Inhalers (MDIs)
After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information)

Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again

 

Drug Shortage: Fentanyl transdermal patch


Drug Shortage: Fentanyl transdermal patch
Availability information updated.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary.

Pet Food Products Seized at PETCO Distribution Center
Consumers who bought animal food products from PETCO in 16 states should take certain precautions

Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice.

July 10, 2008
 

U.S. advisers reject strong epilepsy drug warning - MSN UK News


U.S. advisers reject strong epilepsy drug warning - MSN UK News
BELTSVILLE, Maryland (Reuters) - Anti-seizure drugs used to treat epilepsy carry an increased risk of suicidal thoughts and behaviour but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday. Members of the Food and
Source: news.uk.msn.com

Panel rejects strong epilepsy drug warning - Reuters
BELTSVILLE, Maryland (Reuters) - Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday. Members of the Food and
Source: www.reuters.com

Lighting A Path To Drug Discovery - Forbes
Instead of buying a biotech with drugs already in human trials, some of pharma's biggest players are starting from scratch. In recent years pharmaceutical firms have learned the hard way that developing new drugs doesn’t always mean those drugs
Source: www.forbes.com

 

FDA orders Cipro warning - Los Angeles Times


FDA orders Cipro warning - Los Angeles Times
Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they might lead to serious tendon ruptures that could leave patients incapacitated and needing extensive surgery
Source: www.latimes.com

FDA Panel: No Black Box Warning On Epilepsy Drugs - KSDK
WASHINGTON (AP) -- Drugs used to treat epileptic seizures can raise suicide risks, but not enough to warrant the strongest warning labels available, a government panel of experts said Thursday. Advisers to the Food and Drug Administration voted 14-4
Source: www.ksdk.com

FDA Panel Recommends Against Adding Warnings to Epilepsy Drugs - Wall Street Journal
BELTSVILLE, Md. -- A Food and Drug Administration panel on Thursday did not recommend adding the agency's toughest warnings to labels of epilepsy drugs, saying studies didn't show a high enough risk for suicidal behavior. The move could be a boon to
Source: online.wsj.com

Intel's in-home health device gets FDA nod - CNET News
The new Intel Health Guide --which collects vital signs and allows for remote interactions between patient and doctor--may soon make its way into the homes of consumers with chronic health conditions such as diabetes and congestive heart failure. The
Source: news.cnet.com

Epilepsy Drugs Don't Need Strict Warnings, Panel Says (Update2) - Bloomberg
July 10 (Bloomberg) -- Epilepsy drugs shouldn't get the strictest U.S. warning about suicide risks because the alert may cause people to shun treatment they need, advisers said. The Food and Drug Administration advisory panel agreed with the agency's
Source: www.bloomberg.com

New Epilepsy Warnings Sought By FDA - Overthelimit.info
Washington, D.C.- There are warnings that are featured on the packages of epilepsy medications at the current time, but the federal supervising agency overseeing them wants to seriously strengthen the type and intensity of the warnings. The Food and
Source: www.overthelimit.info

Intel gets FDA OK for personal health system - San Diego Union-Tribune
CHICAGO – Intel Corp, the world's biggest computer chip maker, Thursday won clearance from the Food and Drug Administration to sell an in-home health monitoring system for patients with chronic conditions. The system, called Health Guide, combines
Source: www.signonsandiego.com

US panel rejects strong epilepsy drug warning - Forbes
BELTSVILLE, Md. (Reuters) - Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a U.S. advisory panel concluded Thursday. Members of the Food and Drug
Source: www.forbes.com

 

UPDATE 1-Pfizer argues against epilepsy drug warning - Reuters


UPDATE 1-Pfizer argues against epilepsy drug warning - Reuters
BELTSVILLE, Md., July 10 (Reuters) - Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications
Source: www.reuters.com

No China Trips by U.S. Food Inspectors - CNS News
(CNSNews.com) - U.S. Food and Drug Administration inspectors made 13 visits to Fiji in 2007 for food inspections and no visits at all to China, according to a study released to Congress recently by the Government Accountability Office (GAO). Fiji
Source: www.cnsnews.com

FDA Holds Hearings on Epilepsy Drug Suicide Risk - Wired
The potential suicide risk posed by eleven popular epilepsy drugs is the subject of a hearing held today by the U.S. Food and Drug Administration. An FDA analysis of 199 studies showed that .43 percent of people taking the drugs committed suicide or
Source: blog.wired.com

Pfizer denies suicide risks with epilepsy drugs - Forbes
Pfizer Inc. told government officials Thursday its drug Lyrica should not receive stern warnings about suicide risks that regulators are advocating for all epilepsy drugs. The world's largest drug maker defended the safety of its blockbuster
Source: www.forbes.com

FDA issues warning on Cipro, similar antibiotics - Washington Post
WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and
Source: www.washingtonpost.com

Pfizer argues against epilepsy drug warning - Reuters
BELTSVILLE, Maryland (Reuters) - Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications, despite concerns from U.S. health regulators. The
Source: www.reuters.com

 

Stronger Warnings Requested for Fluoroquinolones


Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary.

Herceptin 440 mg Vials and BWFI Diluent
Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

Red Tomato Warning Expanded Nationwide
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes.

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.

Drug Shortage: MVI Adult Injectable
Hospira information updated.

Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production.

FDA 101: Biological Products
Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies.

Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial
Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial

Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children.

 

CORRECT: EXACT SCIENCES TIMING TO ALLOW FOR POTENTIAL FDA CLEARANCE IN - Forbes


CORRECT: EXACT SCIENCES TIMING TO ALLOW FOR POTENTIAL FDA CLEARANCE IN - Forbes
Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of
Source: www.forbes.com

Lutronic Announces FDA Clearance and Immediate Availability of its - Forbes
Lutronic, Inc., one of the world's leading developers and manufacturers of aesthetic and medical laser systems, announced today that it has received regulatory clearance from the U.S. FDA (Food and Drug Administration) for the eCO2 system. Using the
Source: www.forbes.com

A Drug Safety Warning That Could Harm - ABC News
Ironic, but true -- some doctors are worried about the dangers of the Food and Drug Administration's latest safety effort concerning a class of epilepsy drugs. FDA staff is recommending the agency require a warning to highlight suicide risk on
Source: www.abcnews.go.com

Intel Receives FDA Market Clearance on In-Home Medical Device for - MSN MoneyCentral
Intel Corporation today announced the receipt of 510(k) market clearance from the U.S. Food and Drug Administration (FDA) on Intel ’ s personal health system, the Intel ® Health Guide, a care management tool for healthcare professionals who manage
Source: news.moneycentral.msn.com

Outbreak: Salmonella linked to tomatoes has FDA baffled - Danbury News-Times
The national salmonella outbreak linked to tomatoes has now reached 1,017 confirmed cases -- with four in Connecticut and 28 in New York. That makes this the worst outbreak of illness due to food contamination in years, and federal health officials
Source: www.newstimes.com

FDA issues warning on Cipro, similar antibiotics - Washington Post
WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and
Source: www.washingtonpost.com

 

How to Dispose of Unused Medicines


How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

 

ViroPharma: FDA committee will have generics focus - MSN MoneyCentral


ViroPharma: FDA committee will have generics focus - MSN MoneyCentral
EXTON, Pa. (AP) - ViroPharma Inc. said Tuesday an upcoming Food and Drug Administration advisory committee meeting will focus on general generic drug issues and not specifically on the company's only marketed treatment, Vancocin. Wall Street has been
Source: moneycentral.msn.com

1,000 sickened in salmonella outbreak - Chicago Tribune
WASHINGTON — Salmonella poisoning has sickened more than 1,000 people in 41 states, the District of Columbia and Canada, and federal health officials have now linked jalapeno and serrano peppers to the outbreak. Illinois has reported 100 salmonella
Source: www.chicagotribune.com

FDA orders 'black box' label on some antibiotics - CNN
(CNN) -- The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendonitis. Cipro is one of the drugs for
Source: www.cnn.com

Eurand Names Bill Newbould Vice President, Investor Relations - MSN MoneyCentral
PHILADELPHIA, July 10, 2008 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug
Source: news.moneycentral.msn.com

CORRECT: EXACT SCIENCES TIMING TO ALLOW FOR POTENTIAL FDA CLEARANCE IN - Forbes
Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of
Source: www.forbes.com

UPDATE 1-FDA OKs Invitrogen genetic test for breast cancer - Reuters
WASHINGTON, July 8 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Invitrogen Corp's (IVGN.O: Quote , Profile , Research , Stock Buzz ) genetic test for determining whether patients with breast cancer are good candidates for
Source: www.reuters.com

Exact Sciences Provides Regulatory Update for Its Version 2 Stool - MSN MoneyCentral
EXACT Sciences Corporation EXAS today announced that it has confirmed with the U.S. Food and Drug Administration (FDA) the clinical performance characteristics and the minimum number of average-risk cancer samples that will be required for validation
Source: news.moneycentral.msn.com

 

1,000 sickened in salmonella outbreak - Chicago Tribune


1,000 sickened in salmonella outbreak - Chicago Tribune
WASHINGTON — Salmonella poisoning has sickened more than 1,000 people in 41 states, the District of Columbia and Canada, and federal health officials have now linked jalapeno and serrano peppers to the outbreak. Illinois has reported 100 salmonella
Source: www.chicagotribune.com

Exact Sciences Provides Regulatory Update for Its Version 2 Stool - MSN MoneyCentral
EXACT Sciences Corporation EXAS today announced that it has confirmed with the U.S. Food and Drug Administration (FDA) the clinical performance characteristics and the minimum number of average-risk cancer samples that will be required for validation
Source: news.moneycentral.msn.com

FDA issues warning on Cipro, similar antibiotics - Washington Post
WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and
Source: www.washingtonpost.com

4 out of 5 sunscreens inadequate, study finds - San Francisco Gate
del.icio.us When temperatures soar past the century mark around the Bay Area, people head for the beach with all of the usual gear in tow. Think towels, Frisbees, coolers, umbrellas. And sunscreen. Oceans of it. Americans will spend more than $1.1
Source: www.sfgate.com

Insmed Announces First Human Bioequivalence Data for a Follow-on - MSN MoneyCentral
Company Intends to Request Meeting with FDA Regarding Possible Phase III Trial Based on Human Data Demonstrating Bioequivalence of INS-19 to Neupogen(R) RICHMOND, Va., July 10, 2008 /PRNewswire-FirstCall/ -- Insmed Inc. INSM , a developer of follow
Source: news.moneycentral.msn.com

FDA OKs Invitrogen genetic test for breast cancer - Reuters
WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Invitrogen Corp's genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin. Invitrogen's test, the SPOT
Source: www.reuters.com

FDA calls for urgent warning on tendon risks - Boston Globe
WASHINGTON— Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and
Source: www.boston.com

FDA calls for - MSNBC
WASHINGTON - Federal drug safety officials have imposed the government’s most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and
Source: www.msnbc.msn.com

 

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs


FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children.

Wrinkle Relief: Injectable Cosmetic Fillers
Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done.

Heartworm Prevention in Your Pet
A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program.

 

Drug firms give millions to Vt. doctors - Brattleboro Reformer


Drug firms give millions to Vt. doctors - Brattleboro Reformer
BRATTLEBORO -- Pharmaceutical companies increased the amount of money given to doctors in the state last year, despite Vermont's law that requires disclosure of the gifts. Drug companies gave out more than $3 million in 2007 to Vermont physicians
Source: www.reformer.com

U.S. unites with Europe, Australia on drug inspections - Los Angeles Times
WASHINGTON -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries such as China and India that make an increasing share of the active ingredients in medications
Source: www.latimes.com

Jalapeños now eyed in salmonella probe - Newsday
Jalapeño peppers and salmonella-tainted tomatoes may have been grown on the same farm or the two intermingled somewhere in produce-distribution channels on their way to consumers, federal health experts said yesterday as they attempted to explain
Source: www.newsday.com

US futures point to mild rise; techs fall in Europe - Reuters UK
* U.S. stock futures point to a modest recovery at the start of trade. September Dow Jones DJU8, Standard & Poor's and Nasdaq 100 futures are up between 0.2 and 0.3 percent by 0915 GMT. U.S. benchmark indexes .DJI .SPX .IXIC fell by more than 2
Source: uk.reuters.com

US Food Inspectors Made No Trips to China Last Year - CNS News
(CNSNews.com) - U.S. Food and Drug Administration inspectors made 13 visits to Fiji in 2007 for food inspections and no visits at all to China, according to a study released to Congress recently by the Government Accountability Office (GAO). Fiji
Source: www.cnsnews.com

Congress on drug money - Times-Argus
On Monday, the American Association of Pediatrics promoted using anti-cholesterol statin drugs in children as young as 8 years of age, essentially turning them into guinea pigs for an experimental treatment. On Wednesday, the Senate reversed itself
Source: www.timesargus.com

July 9, 2008
 

Ability to track foods limited - St. Petersburg Times


Ability to track foods limited - St. Petersburg Times
More than 1,000 people in 41 states and the District of Columbia have now been sickened in the nation's salmonella outbreak, in what officials said Wednesday was the largest food-borne outbreak in the last decade. And some food safety experts this
Source: www.tampabay.com

FDA changing notices on drug decisions - Reuters
WASHINGTON (Reuters) - U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved, the Food and Drug Administration said on Wednesday. Companies have been receiving "approvable letters" indicating a
Source: www.reuters.com

Merck, FDA expand Gardasil warnings - The Washington Times
Merck & Co. and the Food and Drug Administration in June expanded the possible adverse reactions for Gardasil , the widely advertised cervical cancer vaccine for girls and young women, to include joint and muscle pain, fatigue, physical weakness and
Source: washingtontimes.com

FDA approves revolutionary laser for wide-use pain relief - Asheville Citizen-Times
ASHEVILLE – Dr. Dru’s Chiropractic, Dru Aguilar, 438 Montford Ave., announces the Food and Drug Administration’s (FDA) approval of the Erchonia3LT laser to use for pain relief in patients suffering from chronic and acute pain. The laser
Source: www.citizen-times.com

FDA to boost suicide risk warnings - Political Gateway
WASHINGTON, July 10 (UPI) -- The U.S. Food and Drug Administration is expected Thursday to recommend black-box warnings on suicide risk for 11 epilepsy drugs. The agency has put warnings about suicidality --suicide risk and suicidal behavior-- on
Source: www.politicalgateway.com

FDA Approves Genetic Test for Breast Cancer - BusinessWeek
TUESDAY, July 8 (HealthDay News) -- A genetic test to determine whether a breast cancer patient is likely to respond to treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration. The SPOT-Light HER2
Source: www.businessweek.com

US, Europe, Australia unite on drug inspections - Chicago Tribune
WASHINGTON - Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications. Bush
Source: www.chicagotribune.com

 

Intel gets FDA OK for personal health system - Reuters


Intel gets FDA OK for personal health system - Reuters
CHICAGO, July 10 (Reuters) - Intel Corp (INTC.O: Quote , Profile , Research , Stock Buzz ), the world's biggest computer chip maker, said on Thursday it won clearance from the U.S. Food and Drug Administration to sell a personal in-home health
Source: www.reuters.com

U.S. looks to jalapenos in Salmonella outbreak - Reuters India
WASHINGTON (Reuters) - More than 1,000 people have been sickened in an outbreak of Salmonella food poisoning and federal officials said on Wednesday they now suspected several causes, including jalapeno peppers. Since April, 1,017 people in 41 states
Source: in.reuters.com

US Food Inspectors Made No Trips to China Last Year - CNS News
(CNSNews.com) - U.S. Food and Drug Administration inspectors made 13 visits to Fiji in 2007 for food inspections and no visits at all to China, according to a study released to Congress recently by the Government Accountability Office (GAO). Fiji
Source: www.cnsnews.com

Ability to track foods limited - St. Petersburg Times
More than 1,000 people in 41 states and the District of Columbia have now been sickened in the nation's salmonella outbreak, in what officials said Wednesday was the largest food-borne outbreak in the last decade. And some food safety experts this
Source: www.tampabay.com

 

International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)


International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)
International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.

FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007.

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information.

Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production.

 

U.S. unites with Europe, Australia on drug inspections - Los Angeles Times


U.S. unites with Europe, Australia on drug inspections - Los Angeles Times
WASHINGTON -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries such as China and India that make an increasing share of the active ingredients in medications
Source: www.latimes.com

FDA Asks For Urgent Warning - KELOLAND TV
A common class of antibiotics has gained the strongest ranking from the Food and Drug Administration - but it isn't one they are proud to have earned. The FDA is asking the drug makers of certain common antibiotics used to treat basic bacterial
Source: www.keloland.com

FDA calls for urgent warning on tendon risks - Public Opinion
WASHINGTON—Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing
Source: www.publicopiniononline.com

 

April 2008 Monthly Safety Labeling


April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information.

United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

 

Pet Food Products Seized at PETCO Distribution Center


Pet Food Products Seized at PETCO Distribution Center
Consumers who bought animal food products from PETCO in 16 states should take certain precautions

March 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Warning on Certain Types of Raw Red Tomatoes
FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes.

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.

FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.

 

US, Europe, Australia to expand drug inspections - Seattle Post Intelligencer


US, Europe, Australia to expand drug inspections - Seattle Post Intelligencer
WASHINGTON -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in China and India that make raw materials for medications. Bush administration officials said Wednesday the
Source: seattlepi.nwsource.com

Tracing tomatoes' travels, from farm to table - Newsday
Denise Goodman is one of Long Island 's top experts on the travels of tomatoes: their sometimes long and very often circuitous trek from farm to plate. The Manhasset resident is the proprietor of M&R Tomatoes in the New York City Terminal Market
Source: www.newsday.com

 

US, Europe, Australia to expand drug inspections - Seattle Post Intelligencer


US, Europe, Australia to expand drug inspections - Seattle Post Intelligencer
WASHINGTON -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in China and India that make raw materials for medications. Bush administration officials said Wednesday the
Source: seattlepi.nwsource.com

 

FDA issues warning on Cipro, similar antibiotics - Washington Post


FDA issues warning on Cipro, similar antibiotics - Washington Post
WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and
Source: www.washingtonpost.com

FDA changing notices on drug decisions - Reuters
WASHINGTON (Reuters) - U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved, the Food and Drug Administration said on Wednesday. Companies have been receiving "approvable letters" indicating a
Source: www.reuters.com

 

FDA Takes Action against Seafood Processing Company, Executives


FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.

February 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information.

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

 

FDA Revises Process for Responding to Drug Applications


FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.

Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm...

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.

Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine
FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA...

February 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

 

Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)


Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

July 8, 2008
 

FDA Takes Action against Seafood Processing Company, Executives


FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

Drug Shortage: Fentanyl transdermal patch
Availability information updated.

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

 

FDA 101: Biological Products


FDA 101: Biological Products
Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies.

Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice.

 

Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)


Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper.

United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

 

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center


FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1)
Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).

Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

New Medical Products: New Skin Graft Adhesive Approved
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi...

Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

 

Recall of Nestle Pure Life Purified Water (June 24)


Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

 

FDA clears Invitrogen breast cancer test - CNBC


FDA clears Invitrogen breast cancer test - CNBC
WASHINGTON - The Food and Drug Administration on Tuesday approved a new genetic test from Invitrogen Corp. which identifies breast cancer patients who will respond to a powerful cancer-fighting drug. The test from Carlsbad, Calif.-based Invitrogen
Source: www.cnbc.com

ViroPharma: FDA committee will have generics focus - CNBC
EXTON, Pa. - ViroPharma Inc. said Tuesday an upcoming Food and Drug Administration advisory committee meeting will focus on general generic drug issues and not specifically on the company's only marketed treatment, Vancocin. Wall Street has been
Source: www.cnbc.com

UPDATE 1-FDA OKs Invitrogen genetic test for breast cancer - Reuters
WASHINGTON, July 8 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Invitrogen Corp's (IVGN.O: Quote , Profile , Research , Stock Buzz ) genetic test for determining whether patients with breast cancer are good candidates for
Source: www.reuters.com

 

April 2008 Monthly Safety Labeling


April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Product recalled due to the presence of Burkholderia cepacia.

Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice.

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.

July 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

FDA Announces Limited Return of Heartworm Drug to U.S. Market
ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.

 

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)


ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.

Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.

How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

July 7, 2008
 

UPDATE 2-US FDA urging black box warning for epilepsy drugs - Reuters


UPDATE 2-US FDA urging black box warning for epilepsy drugs - Reuters
WASHINGTON, July 7 (Reuters) - U.S. Food and Drug Administration officials are pushing for a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of a public meeting on the issue. "We are going to
Source: www.reuters.com

 

Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall


Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper.

Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx
FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ...

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.

 

April 2008 Monthly Safety Labeling


April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Morphine Sulfate 60 mg and 30 mg Extended Release Tablets
UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets.

How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them.

Antipsychotics, Conventional and Atypical
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.

Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient.

Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information.

Warning on Certain Types of Raw Red Tomatoes
FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes.

 

US FDA urging black box warning for epilepsy drugs - Forbes


US FDA urging black box warning for epilepsy drugs - Forbes
WASHINGTON (Reuters) - Food and Drug Administration officials are pushing for a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of a public meeting on the issue. "We are going to ask for a
Source: www.forbes.com

U.S. expanding probe of salmonella outbreak - Reuters
WASHINGTON (Reuters) - The U.S. Food and Drug Administration is broadening its testing of food beyond tomatoes, including looking at imported products, to find the source of a salmonella outbreak in the United States, a spokesman said on Monday. The
Source: www.reuters.com

Duley Hopkins & Associates Obtains Licensure For New Blood Management - Chattanoogan
Duley Hopkins & Associates, Inc. announced that the Food and Drug Administration has granted 510(k) clearance for Blood Bank Information Management System (BBIMS), a blood management product used in the collection, processing, labeling, tracking and
Source: www.chattanoogan.com

Shares of Miami-based drug firm tumble - Miami Herald
Shares of Miami-based Noven Pharmaceuticals fell Monday after a Jefferies analyst cut his rating on the company, pointing to slower sales of key products and a weak pipeline. The stock lost 98 cents, or 9.1 percent, to $9.80 in afternoon trading on
Source: www.miamiherald.com

U.S. FDA to urge black box warning for epilepsy drugs - San Diego Union-Tribune
WASHINGTON – Food and Drug Administration officials will seek a strong “black box” warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters Monday. “We are going to ask for a
Source: www.signonsandiego.com

HPV Vaccine Linked To Teen's Paralysis? - CBS News
(CBS) Jenny was a healthy 13-year-old living in Northern California -- until 15 months ago when, her parents say, she received the third and final shot of the vaccine designed to protect against human papillomavirus (HPV). HPV causes a large
Source: www.cbsnews.com

FDA urging black box warning for epilepsy drugs - Reuters UK
WASHINGTON (Reuters) - Food and Drug Administration officials are pushing for a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of a public meeting on the issue. "We are going to ask for a
Source: uk.reuters.com

 

FDA Approves Diaphragm-Pacing Device


FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

 

US FDA seeks black box warning for epilepsy drugs - Forbes


US FDA seeks black box warning for epilepsy drugs - Forbes
United States - WASHINGTON (Reuters) - Food and Drug Administration officials will seek a strong "black box" warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters Monday. "We are
Source: www.forbes.com

U.S. FDA to urge black box warning for epilepsy drugs - San Diego Union-Tribune
WASHINGTON – Food and Drug Administration officials will seek a strong “black box” warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters Monday. “We are going to ask for a
Source: www.signonsandiego.com

 

Heartworm Prevention in Your Pet


Heartworm Prevention in Your Pet
A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program.

Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm...

Wrinkle Relief: Injectable Cosmetic Fillers
Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done.

Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice.

Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.

Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

 

Mexico denies reports that US banned its produce - BusinessWeek


Mexico denies reports that US banned its produce - BusinessWeek
Mexico's Agriculture Department is denying reports that the United States will close its borders to some Mexican produce. The department says it knows of no U.S. plan to stop imports of Mexican cilantro and jalapeno peppers, contrary to U.S. media
Source: www.businessweek.com

FDA Looks for New Salmonella Suspects - WXYZ
The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have been 943 reported
Source: www.wxyz.com

FDA Grants AMDL Clearance to Market the AMDL-ELISA DR-70(R) (FDP - MSN MoneyCentral
TUSTIN, Calif., July 7 /PRNewswire-FirstCall/ -- AMDL ADL , a leading vertically integrated bio-pharmaceutical company with operations in China and the US, announced today the US Food and Drug Administration (FDA) has issued a letter of substantial
Source: news.moneycentral.msn.com

FDA Reports More Cases of Salmonella Illnesses - FOX News
WASHINGTON — The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have
Source: www.foxnews.com

Biopure announces meeting with FDA - Boston Globe
Biopure Corp ., a struggling Cambridge biotechnology company, said today that it has had discussions with the Food and Drug Administration about identifying an acceptable patient population for a new clinical trial of its Hemopure product. Biopure
Source: www.boston.com

Biopure discloses talks with FDA on patient population for Hemopure - Forbes
NEW YORK (Thomson Financial) - Biopure Corp. Monday said it has had discussions with the Food and Drug Administration to identify an acceptable patient population for a new clinical trial of leukemia treatment Hemopure. Biopure (nasdaq: BPUR - news
Source: www.forbes.com

Mexico denies U.S. closing border to peppers, cilantro - Houston Chronicle
MEXICO CITY — Mexico's Agriculture Department is denying reports that the United States will close its borders to some Mexican produce. The department says it knows of no U.S. plan to stop imports of Mexican cilantro and jalapeno peppers, contrary
Source: www.chron.com

Man fights FDA's slow road to drug approval - St. Petersburg Times
ST. PETERSBURG — In his work as a geologist, Steven Walker cleans up environmental messes. In his spare time, the St. Petersburg resident tries to bulldoze a path for dying patients through the Food and Drug Administration. While the FDA has been
Source: www.tampabay.com

FDA reports more cases of salmonella illnesses linked to tomatoes - Cumberland County Sentinel
WASHINGTON (AP) — The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There
Source: www.cumberlink.com

 

Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune


Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune
Baxter International Inc. Chairman and Chief Executive Robert Parkinson is leaving open the possibility that the company may stay out of the business of selling vials of heparin in the U.S. market. The company recalled vials of the popular blood
Source: www.chicagotribune.com

FDA reports more cases of salmonella illnesses - NWITimes.com
WASHINGTON - The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have been
Source: nwitimes.com

FDA reports more cases of salmonella illnesses - NWI.com
WASHINGTON - The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have been
Source: www.thetimesonline.com

FDA reports more instances of illness caused by salmonella - Boston Globe
WASHINGTON - The government yesterday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect, although investigators are testing other types of fresh produce. There have been
Source: www.boston.com

 

Antipsychotics, Conventional and Atypical


Antipsychotics, Conventional and Atypical
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Product recalled due to the presence of Burkholderia cepacia.

ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13)
ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.

Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient.

Drug to be Discontinued: Kemadrin (procyclidine hydrochloride)
Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information.

April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)
International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.

July 6, 2008
 

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety


FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product.

March 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children.

Beware of Bug Bites and Stings
Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings.

Antipsychotics, Conventional and Atypical
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.

Warning on Certain Types of Raw Red Tomatoes
FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes.

Prepare for Hurricanes and Floods: Advice From FDA
This updated article gives tips on how to keep food, medical products, and pets safe during an emergency.

Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.

 

Drug Shortage: Digitek (digoxin tablets, USP)


Drug Shortage: Digitek (digoxin tablets, USP)
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website.

Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine
FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA...

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products.

Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

 

FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A


FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A
Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.

Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again

Wrinkle Relief: Injectable Cosmetic Fillers
Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done.

FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America�s food supply since unveiling its Food Protection Plan in November 2007.

 

FDA still puzzled by salmonella outbreak - KVUE


FDA still puzzled by salmonella outbreak - KVUE
AUTLAN, Mexico — Inspectors are collecting soil, water and produce samples, reviewing export logs and combing packing plants in three major tomato-growing states in Mexico. But the U.S. Food and Drug Administration appears no closer to finding the
Source: www.kvue.com

 

Costly Cancer Drug Has Limited Success - The Ledger


Costly Cancer Drug Has Limited Success - The Ledger
NEW YORK | It took only an instant for 58-year-old Gailanne Reeh to go from the picture of health to death's door. By chance, her doctor noticed a lump under her arm during a routine exam. It turned out to be advanced breast cancer. The surgeon, she
Source: www.theledger.com

PRIMARY SOURCE - Los Angeles Times
Andrew C. von Eschenbach, commissioner of the Food and Drug Administration, visited the editorial board Wednesday. The FDA is facing an outbreak of salmonella in tomatoes and attempting to upgrade its processes to deal with the changing food market
Source: www.latimes.com

More salmonella cases reported - Chicago Sun-Times
WASHINGTON -- The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect. There have been 943 reported cases nationwide, with at least 130
Source: www.suntimes.com

Costly cancer drug offers hope yet dilemma - Minneapolis Star Tribune
It took only an instant for 58-year-old Gailanne Reeh to go from the picture of health to death's door. By chance, her doctor noticed a lump under her arm during a routine exam. It turned out to be advanced breast cancer. Soon she was having tests to
Source: www.startribune.com

 

Drug Shortage: MVI Adult Injectable


Drug Shortage: MVI Adult Injectable
Hospira information updated.

Antipsychotics, Conventional and Atypical
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.

 

Probe of growing outbreak intensifies - Chicago Tribune


Probe of growing outbreak intensifies - Chicago Tribune
WASHINGTON — The government on Saturday increased to 943 the number of people reported being sickened in a record salmonella outbreak, in which tomatoes are the leading suspect. The Food and Drug Administration also said it had begun looking at
Source: www.chicagotribune.com

And Bring the Sunscreen - New York Times
Summer is the time to slather exposed skin with sunscreen — the thicker, the higher the S.P.F., the better. Yet consumers are confused about which sunscreens work and which could be harmful to humans and the environment. The Food and Drug
Source: www.nytimes.com

Cancer drugs' costs pose a dilemma - Seattle Times
Cancer drugs constitute the second-biggest category of drugs in the United States, behind cholesterol-lowering medicines, and accounted for $17.8 billion of total prescription-drug sales of $286.5 billion in 2007, according to IMS Health, a health
Source: seattletimes.nwsource.com

Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune
Baxter International Inc. Chairman and Chief Executive Robert Parkinson is leaving open the possibility that the company may stay out of the business of selling vials of heparin in the U.S. market. The company recalled vials of the popular blood
Source: www.chicagotribune.com

Tomato outbreak is reminder to follow food safety tips - Atlanta Journal Constitution
Salmonella probe adds foods served with tomatoes WASHINGTON — Adding to tomato confusion, the government is about to start testing numerous other types of fresh produce in the hunt for the source of the nation's record salmonella outbreak — even
Source: www.ajc.com

The unhealthy ties that bind FDA to drug firms - Boston Globe
In her new book Alison Bass obeys the most important rule of investigative journalism: She follows the money wherever it leads. In "Side Effects," her examination of mammoth pharmaceutical companies and their pursuit of profits at any cost, she
Source: www.boston.com

 

The unhealthy ties that bind FDA to drug firms - Boston Globe


The unhealthy ties that bind FDA to drug firms - Boston Globe
In her new book Alison Bass obeys the most important rule of investigative journalism: She follows the money wherever it leads. In "Side Effects," her examination of mammoth pharmaceutical companies and their pursuit of profits at any cost, she
Source: www.boston.com

 

FDA Panel Calls for More Testing of Diabetes Drugs - BusinessWeek


FDA Panel Calls for More Testing of Diabetes Drugs - BusinessWeek
WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. The
Source: www.businessweek.com

FDA slowing drugs getting to market - San Antonio Express News
Nearly four years after Merck & Co. yanked the painkiller Vioxx off the market, beleaguered pharmaceutical industry executives say they are facing a tough new regulatory climate that is altering the landscape of drug development. During the past 16
Source: www.mysanantonio.com

FDA widens salmonella vegetable hunt - Philadelphia Inquirer
WASHINGTON - Adding to tomato confusion, the government is about to start testing numerous other types of fresh produce in the hunt for the source of the nation's record salmonella outbreak - even as it insists tomatoes remain the leading suspect
Source: www.philly.com

FDA reports more cases of salmonella illnesses - Guardian Unlimited
WASHINGTON (AP) - The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have
Source: www.guardian.co.uk

No Salad Days at FDA - Daily Herald
WASHINGTON -- The latest E. coli/spinach and salmonella/tomatoes scares have renewed public concern about the Food and Drug Administration's oversight of food safety. And a recent Government Accountability Office report doesn't do much to put tomato
Source: www.heraldextra.com

Mobile pharmacy owner cited by FDA says changes underway - Everything Alabama
MOBILE, Ala. (AP) — The owner of a Mobile pharmacy cited for violating FDA rules by manufacturing and selling large amounts of compounded drugs said he is working with the federal agency to fix problems. Food and Drug Administration inspectors said
Source: www.al.com

The Perils Of Industrial Agriculture - San Francisco Gate
Beef. Spinach. Pet food . Now tomatoes. What is up with our food being contaminated? There was an E. coli recall issued yesterday . If you've read The Omnivore's Dilemma , you know that grass-fed cattle produce healthier meat and do not get E. coli
Source: www.sfgate.com

Jalapeños suspect in Salmonella scare - Seattle Times
WASHINGTON — Jalapeño peppers are a new focus of the investigation into the salmonella outbreak that has sickened hundreds of people in at least 40 states, including Washington. Government health investigators had initially focused on some types
Source: seattletimes.nwsource.com

Probe of growing outbreak intensifies - Chicago Tribune
WASHINGTON — The government on Saturday increased to 943 the number of people reported being sickened in a record salmonella outbreak, in which tomatoes are the leading suspect. The Food and Drug Administration also said it had begun looking at
Source: www.chicagotribune.com

 

Drug Shortage: Fentanyl transdermal patch


Drug Shortage: Fentanyl transdermal patch
Availability information updated.

Drug Shortage: MVI Adult Injectable
Hospira information updated.

FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A
Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.

 

Antipsychotics, Conventional and Atypical


Antipsychotics, Conventional and Atypical
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.

Beware of Bug Bites and Stings
Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings.

Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx
The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ...

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Product recalled due to the presence of Burkholderia cepacia.

Your Guide to Reporting Problems to FDA
This guide provides tips and a quick-reference chart to help you report a problem to FDA.

Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm...

July 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine
FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA...

April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx
FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ...

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