May 25, 2008Drug taken to stop smoking is linked to traffic mishaps - Los Angeles Times Drug taken to stop smoking is linked to traffic mishaps - Los Angeles Times
WASHINGTON -- Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, and a couple of nights later, as he was Source: www.latimes.com Anti-smoking drug receives new scrutiny - Chicago Tribune WASHINGTON -- Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, but a couple of nights later, as he was Source: www.chicagotribune.com FDA still awaiting OK to open China offices - BusinessWeek Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the United States, a top health official said Friday. The Food and Drug Administration wants to establish foreign offices in three Chinese Source: www.businessweek.com Doctors deem tan in a bottle a safer alternative - Memphis Commercial Appeal Fill out the survey for a chance to win a $100 gift certificate to one of the Memphis Most restaurants. These days Colleen Smith's tan comes from a bottle, not the sun. Not yet 30, the Memphis advertising account executive has had two melanomas Source: www.commercialappeal.com FDA says nipple cream could harm infants - Reuters WASHINGTON (Reuters) - Consumers should not buy or use Mommy's Bliss Nipple Cream, marketed by San Rafael, California-based MOM Enterprises Inc, due to ingredients that could harm infants, the U.S. Food and Drug Administration said on Friday. The Source: www.reuters.com FDA warns mothers about nipple cream - MSNBC WASHINGTON - The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif. The cream, promoted to nursing mothers to help soothe dry or cracked Source: www.msnbc.msn.com FDA Warns Mothers About Nipple Cream - FOX News The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif. The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains Source: www.foxnews.com Central American office for FDA? - Baltimore Sun WASHINGTON - Health and Human Services Secretary Michael O. Leavitt, who has been working to open Food and Drug Administration offices in China, said yesterday that he believes a similar office should be opened in Central America. Leavitt Source: www.baltimoresun.com Labels: FDA New Medical Products: FDA Licenses New Hemophilia Treatment New Medical Products: FDA Licenses New Hemophilia Treatment
FDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients ... Preventing Medical Errors: Mistakenly Swallowing Inhaler Capsules FDA has issued an advisory about the danger of mistakenly swallowing Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) inhalation capsules. These capsules are intended to be used with inhalation devic... Recalls and Safety Alerts: Unsafe Use of Extended-Release Tussionex Suspension FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorp... Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Covidien now has Lymphazurin 1% injection available. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Dear Healthcare Professional Letter is available. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Current Drug Shortage: Neupro (rotigotine transdermal system) UCB is preparing to recall all Neupro lots in the U.S. by May 2008 Labels: FDA Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16)
Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Heparin Sodium Injection FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ... Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Labels: FDA Scenes from Cannes - CNN Scenes from Cannes - CNN
1 Boeing 747 'splits' on take off 2 Obama wants FL, MI resolution 3 'Harry Potter' actor stabbed 4 Clinton: Parallels 'unthinkable' 5 Damaging aftershock hits China 6 NASA preps for Mars landing 7 FARC leader dead 8 Hamilton wins Monaco GP 9 76-year Source: edition.cnn.com Drug taken to stop smoking is linked to traffic mishaps - Los Angeles Times WASHINGTON -- Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, and a couple of nights later, as he was Source: www.latimes.com Anti-smoking drug receives new scrutiny - Detroit News WASHINGTON -- Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, but a couple of nights later, as he was Source: www.detnews.com FDA warns mothers about nipple cream - MSNBC WASHINGTON - The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif. The cream, promoted to nursing mothers to help soothe dry or cracked Source: www.msnbc.msn.com FDA Waits for Approval To Open Offices in China - Wall Street Journal WASHINGTON -- Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the U.S., a top health official said Friday. The Food and Drug Administration wants to establish foreign offices in three Source: online.wsj.com FDA says nipple cream could harm infants - Reuters WASHINGTON (Reuters) - Consumers should not buy or use Mommy's Bliss Nipple Cream, marketed by San Rafael, California-based MOM Enterprises Inc, due to ingredients that could harm infants, the U.S. Food and Drug Administration said on Friday. The Source: www.reuters.com Central American office for FDA? - Baltimore Sun WASHINGTON - Health and Human Services Secretary Michael O. Leavitt, who has been working to open Food and Drug Administration offices in China, said yesterday that he believes a similar office should be opened in Central America. Leavitt Source: www.baltimoresun.com U.S. FDA says nipple cream could harm infants - Forbes United States - WASHINGTON (Reuters) - Consumers should not buy or use Mommy's Bliss Nipple Cream, marketed by San Rafael, California-based MOM Enterprises Inc, due to ingredients that could harm infants, the U.S. Food and Drug Administration said Source: www.forbes.com FDA still awaiting OK to open China offices - BusinessWeek Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the United States, a top health official said Friday. The Food and Drug Administration wants to establish foreign offices in three Chinese Source: www.businessweek.com Labels: FDA Controlling Cholesterol with Statins Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Dear Healthcare Professional Letter is available. Use Eye Cosmetics Safely April is Women's Eye Health and Safety Month. Here are tips from FDA about storing, applying, wearing, and removing eye cosmetics. Device Identifies Fatty Deposits in Coronary Arteries A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. New Type of Latex Glove Cleared FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Warning About Total Body Liquid Supplements FDA is advising consumers not to buy or use certain Total Body liquid dietary supplement products because of reports of serious reactions. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. 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. Labels: FDA FDA Approves Entereg to Help Restore Bowel Function Following Surgery FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Coronary Artery Plaque Imaging Device Cleared by FDA The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries. Current Drug Shortage: Neupro (rotigotine transdermal system) UCB is preparing to recall all Neupro lots in the U.S. by May 2008 May 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Labels: FDA Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
Dear Healthcare Professional Letter is available. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. May 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Heparin Sodium Injection Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. Coronary Artery Plaque Imaging Device Cleared by FDA The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries. Labels: FDA Three prescriptions for lower drug costs - Fort Lauderdale Sun-Sentinel Three prescriptions for lower drug costs - Fort Lauderdale Sun-Sentinel
If you're one of the nearly 47 million Americans without health insurance, or if your plan offers only limited drug coverage or requires high copayments, you're probably feeling the pinch of rising costs for prescription drugs. From Consumer Reports Source: www.sun-sentinel.com FDA still awaiting OK to open China offices - BusinessWeek Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the United States, a top health official said Friday. The Food and Drug Administration wants to establish foreign offices in three Chinese Source: www.businessweek.com America's faux government - Boston Globe I LOVE Hollywood sets of perfect streets that turn out to be nothing but fronts. It's so clever. Alas, I think that's what we're going to find when we open the doors of the White House in 2009. See, I've been wondering where all the money is coming Source: www.boston.com FDA wants more data on Wyeth osteoporosis drug - Boston Globe COLLEGEVILLE, Pa.— Wyeth said Friday that U.S. regulators have again denied approval of the drug maker's osteoporosis drug bazedoxifene requesting additional information on stroke and blood clot issues. The Food and Drug Administration issued Wyeth Source: www.boston.com Labels: FDA Wyeth Drags Through Drug Approval Process - Forbes Wyeth Drags Through Drug Approval Process - Forbes
Drug approval is a tricky business and pharmaceutical companies are facing more scrutiny regarding their drug applications than in the past. Wyeth Pharmaceuticals , in particular, is having trouble coping with the regulations. The company is not only Source: www.forbes.com Drug taken to stop smoking is linked to traffic mishaps - Los Angeles Times WASHINGTON -- Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, and a couple of nights later, as he was Source: www.latimes.com FDA wants more data on Wyeth osteoporosis drug - Forbes Wyeth said Friday that U.S. regulators have again denied approval of the drug maker's osteoporosis drug bazedoxifene requesting additional information on stroke and blood clot issues. The Food and Drug Administration issued Wyeth a third "approvable Source: www.forbes.com Wyeth Says FDA Requests Added Information On Drug - CNN Money Wyeth (WYE) said Friday that its pharmaceuticals division received an approvable letter from the Food and Drug Administration for bazedoxifene, a treatment for postmenopausal osteoporosis. The Madison, N.J. , drugmaker said that in the letter, the Source: money.cnn.com McCarthyism, the pope and gutter balls - Detroit News Seeing Pope Benedict XVI driven around in a bullet-proof vehicle reminds me of how much times have changed over the years. I can remember when President Franklin D. Roosevelt rode through Harlem in an open car. A reader's response to my column about Source: www.detnews.com America's faux government - Boston Globe I LOVE Hollywood sets of perfect streets that turn out to be nothing but fronts. It's so clever. Alas, I think that's what we're going to find when we open the doors of the White House in 2009. See, I've been wondering where all the money is coming Source: www.boston.com Pet food settlement reached - Tulsa World Menu Foods Ltd., Wal-Mart Stores Inc. and five other companies sued by consumers last year for selling melamine-tainted pet food have asked a U.S. judge to approve a $24 million settlement. The companies will create a fund allowing consumers to Source: www.tulsaworld.com FDA warns mothers about nipple cream - Los Angeles Times WASHINGTON -- The Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif. The cream, promoted to nursing mothers to help soothe dry or cracked Source: www.latimes.com Labels: FDA Drug taken to stop smoking is linked to traffic mishaps - Los Angeles Times Drug taken to stop smoking is linked to traffic mishaps - Los Angeles Times
WASHINGTON -- Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, and a couple of nights later, as he was Source: www.latimes.com Labels: FDA May 24, 2008Bayer Removes Remaining Trasylol Stock Bayer Removes Remaining Trasylol Stock
Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. Use Eye Cosmetics Safely April is Women's Eye Health and Safety Month. Here are tips from FDA about storing, applying, wearing, and removing eye cosmetics. DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Labels: FDA Wyeth receives FDA approval letter for bazedoxifene - CNBC Wyeth receives FDA approval letter for bazedoxifene - CNBC
BOSTON (Thomson Financial) - Wyeth Friday said it received an approval letter from the Food and Drug Administration for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis. In the letter, the FDA Source: www.cnbc.com FDA, Medicare to form early-warning drug network - Los Angeles Times WASHINGTON -- Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced a joint venture Thursday that promises to improve prescription drug safety for all Americans, while potentially Source: www.latimes.com FDA Warns Mothers About Nipple Cream - ABC News The FDA has warned Mommy's Bliss Nipple Cream contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants. (Raul Touzon/National Geographic/Getty Images) The Food and Drug Administration on Friday warned women not to Source: www.abcnews.go.com BIO Lauds Senate for FDA and NIH Funding Boosts - Forbes The Food and Drug Administration and National Institutes of Health received much-needed funding increases in the FY 2008 Supplemental Appropriations bill the Senate passed today. In its $400 million appropriation to NIH, the Senate bill recognizes Source: www.forbes.com Jailed Saudi activist 'in terrible state,' wife says - CNN (CNN) -- The wife of a Saudi Arabian political science professor and outspoken human rights advocate said that she visited her husband in jail Saturday and that he is "in a terrible state." Matrook al-Faleh, shown in 2004, was seized after he Source: edition.cnn.com FDA wants more data on Wyeth osteoporosis drug - Forbes Wyeth said Friday that U.S. regulators have again denied approval of the drug maker's osteoporosis drug bazedoxifene requesting additional information on stroke and blood clot issues. The Food and Drug Administration issued Wyeth a third "approvable Source: www.forbes.com Stewart subpoena not ruled out - Baltimore Sun WASHINGTON - Lawmakers leading an investigation of Martha Stewart's sale of ImClone Systems Inc. stock aren't ruling out issuing a subpoena to force her to appear on Capitol Hill. "It may be the only means to get her to come forward and tell her Source: www.baltimoresun.com FDA still awaiting OK to open China offices - Salon May 23rd, 2008 | WASHINGTON -- Chinese bureaucracy is slowing U.S. efforts to increase safety monitoring of food and medicine destined for the United States, a top health official said Friday. The Food and Drug Administration wants to establish Source: www.salon.com Labels: FDA Chantix (varenicline) Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. A Guide to Drug Safety Terms at FDA This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug. FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Labels: FDA Recalls and Safety Alerts: Hepatotoxicity with Prezista Recalls and Safety Alerts: Hepatotoxicity with Prezista
FDA and Tibotec Therapeutics are alerting healthcare professionals about the risk of hepatotoxicity associated with the antiretroviral drug Prezista (darunavir). Prezista, co-administered with ritonavir and other antiretroviral agents, is used to tr... FDA Approves First Generic Ropinirole The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome. FDA Takes Action against Cream Cheese Companies, Executives The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Labels: FDA Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2)
Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. Cardinal Alcohol-Free Mouthwash Product recalled because of the presence of Burkholderia cepacia. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11) Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites. DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Heparin Sodium Injection Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. May 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Labels: FDA Heparin Sodium Injection Heparin Sodium Injection
Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Labels: FDA Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes
Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi... FDA Takes Action against Cream Cheese Companies, Executives The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. Labels: FDA FDA, Medicare to join in plan - Baltimore Sun FDA, Medicare to join in plan - Baltimore Sun
WASHINGTON - Two government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced yesterday a joint venture that promises to improve prescription drug safety for Americans, while potentially reducing Source: www.baltimoresun.com Labels: FDA Trasylol (aprotinin injection) Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Cardinal Alcohol-Free Mouthwash Additional lot recalled because of the presence of Burkholderia cepacia. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11) Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Heparin Sodium Injection FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Labels: FDA Manufacturer Removes Remaining Stocks of Trasylol Manufacturer Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. 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. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA Approves New Formulation of Coagulation Therapy he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. Recalls and Safety Alerts: Liver Injury with Tysabri Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f... Labels: FDA Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23) Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)
WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein. Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25) Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Covidien now has Lymphazurin 1% injection available. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx� Stent Graft System In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx� Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ... Labels: FDA Cardinal Alcohol-Free Mouthwash Cardinal Alcohol-Free Mouthwash
Product recalled because of the presence of Burkholderia cepacia. Bayer Removes Remaining Trasylol Stock Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. Labels: FDA FAA bans Pfizer anti-smoking drug - CNN Money FAA bans Pfizer anti-smoking drug - CNN Money
NEW YORK (AP) -- Pfizer Inc.'s once-promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots Source: money.cnn.com Warning delivered after man dies from toad resin - Seattle Times NEW YORK — Health officials are warning New Yorkers to stay away from an illegal aphrodisiac made from toad venom after the product apparently killed a man. The city's poison-control center issued the warning Friday after receiving a hospital Source: seattletimes.nwsource.com Labels: FDA May 23, 2008Enbrel (etanercept) Enbrel (etanercept)
Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis. May 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Heparin Sodium Injection FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. Heparin Sodium Injection Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. Labels: FDA Controlling Cholesterol with Statins Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Covidien now has Lymphazurin 1% injection available. 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. Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Dear Healthcare Professional Letter is available. New Type of Latex Glove Cleared FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex. A Guide to Drug Safety Terms at FDA This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug. Cardinal Alcohol-Free Mouthwash Product recalled because of the presence of Burkholderia cepacia. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Labels: FDA Drug Approved for Irritable Bowel Syndrome with Constipation Drug Approved for Irritable Bowel Syndrome with Constipation
FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. FDA Takes Action against Cream Cheese Companies, Executives The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. Use Eye Cosmetics Safely April is Women's Eye Health and Safety Month. Here are tips from FDA about storing, applying, wearing, and removing eye cosmetics. FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. Salmonella Illnesses May be Linked to Recalled Cereal At least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Labels: FDA Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. 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. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Labels: FDA Use Eye Cosmetics Safely Use Eye Cosmetics Safely
April is Women's Eye Health and Safety Month. Here are tips from FDA about storing, applying, wearing, and removing eye cosmetics. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ... DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25) Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Drug Approved for Irritable Bowel Syndrome with Constipation FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over Preventing Medical Errors: Mistakenly Swallowing Inhaler Capsules FDA has issued an advisory about the danger of mistakenly swallowing Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) inhalation capsules. These capsules are intended to be used with inhalation devic... Labels: FDA FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). Heparin Sodium Injection FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. Coronary Artery Plaque Imaging Device Cleared by FDA The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Labels: FDA New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. Recalls and Safety Alerts: Hepatotoxicity with Prezista FDA and Tibotec Therapeutics are alerting healthcare professionals about the risk of hepatotoxicity associated with the antiretroviral drug Prezista (darunavir). Prezista, co-administered with ritonavir and other antiretroviral agents, is used to tr... Recalls and Safety Alerts: Liver Injury with Tysabri Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f... New Medical Products: FDA Licenses New Hemophilia Treatment FDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients ... Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Covidien now has Lymphazurin 1% injection available. Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Dear Healthcare Professional Letter is available. Labels: FDA Solodyn (minocycline HCL) Extended Release Tablets 90 mg Solodyn (minocycline HCL) Extended Release Tablets 90 mg
Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Enbrel (etanercept) Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. Labels: FDA FDA Approves Entereg For Bowel Function Following Surgery - eMaxHealth.com FDA Approves Entereg For Bowel Function Following Surgery - eMaxHealth.com
FDA approved Entereg (alvimopan) to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no Source: www.emaxhealth.com Wyeth Receives Approvable Letter From FDA for Bazedoxifene for the - MSN MoneyCentral COLLEGEVILLE, Pa., May 23 /PRNewswire/ -- Wyeth Pharmaceuticals, a division of Wyeth WYE , announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor Source: news.moneycentral.msn.com FDA-Medicare system aimed at drug safety - Herald Tribune Published Friday, May 23, 2008 at 4:30 a.m. Last updated Friday, May 23, 2008 at 5:40 a.m. WASHINGTON — Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms Thursday announced a joint venture Source: www.heraldtribune.com Wyeth receives FDA approval letter for bazedoxifene - Forbes BOSTON (Thomson Financial) - Wyeth Friday said it received an approval letter from the Food and Drug Administration for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis. In the letter, the FDA Source: www.forbes.com BIO Lauds Senate for FDA and NIH Funding Boosts - Forbes The Food and Drug Administration and National Institutes of Health received much-needed funding increases in the FY 2008 Supplemental Appropriations bill the Senate passed today. In its $400 million appropriation to NIH, the Senate bill recognizes Source: www.forbes.com UPDATE 1-US delays approval of Wyeth osteoporosis medicine - Reuters NEW YORK, May 23 (Reuters) - U.S. health regulators have delayed approval of Wyeth's (WYE.N: Quote , Profile , Research ) experimental medicine for treating osteoporosis, requesting information about blood clots and stroke, the drug maker said on Source: www.reuters.com FDA wants more data on Wyeth osteoporosis drug - Boston Globe COLLEGEVILLE, Pa.— Wyeth said Friday that U.S. regulators have again denied approval of the drug maker's osteoporosis drug bazedoxifene requesting additional information on stroke and blood clot issues. The Food and Drug Administration issued Wyeth Source: www.boston.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 FDA, Medicare to form early-warning drug network - Los Angeles Times WASHINGTON -- Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced a joint venture Thursday that promises to improve prescription drug safety for all Americans, while potentially Source: www.latimes.com Labels: FDA New Safety Program to Monitor Medicare Drug Use - FOX News New Safety Program to Monitor Medicare Drug Use - FOX News
Federal health officials will begin monitoring prescription drug usage by millions of Medicare participants in an effort to identify potential safety problems. The Food and Drug Administration has been under increasing pressure to develop a Source: www.foxnews.com Akorn-Strides LLC gets FDA OK for rifampin for injection USP - CNBC NEW YORK (Thomson Financial) - Akorn-Strides LLC Friday said the Food and Drug Administration approved its abbreviated new drug application for rifampin for injection USP in a 600-milligram vial. Rifampin is a semi-synthetic antibiotic indicated for Source: www.cnbc.com Research Update - MSN MoneyCentral Novo Nordisk today announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for the approval of Source: news.moneycentral.msn.com FDA-Medicare system aimed at drug safety - Herald Tribune The Food and Drug Administration and Medicare agreed on rules for using information from Medicare's giant claims databases to create a computerized early warning network for problems with medications and medical devices that come to light after they Source: www.heraldtribune.com FDA, Medicare to form early-warning drug network - Los Angeles Times WASHINGTON -- Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced a joint venture Thursday that promises to improve prescription drug safety for all Americans, while potentially Source: www.latimes.com Phase Forward Wins 2008 CODiE Award for Best Medical and Health - MSN MoneyCentral Phase Forward PFWD , a leading provider of data management solutions for clinical trials and drug safety, has been named by the Software & Information Industry Association (SIIA) as the winner of the 2008 CODiE Award for Best Medical and Health Source: news.moneycentral.msn.com FDA to keep closer eye on drug, device safety - MSNBC WASHINGTON - U.S. health officials on Thursday announced plans for a new computer tracking system designed to help them identify dangers from prescription drugs and medical devices already on the market. The system would enable the Food and Drug Source: www.msnbc.msn.com UPDATE 1-US delays approval of Wyeth osteoporosis medicine - Reuters NEW YORK, May 23 (Reuters) - U.S. health regulators have delayed approval of Wyeth's (WYE.N: Quote , Profile , Research ) experimental medicine for treating osteoporosis, requesting information about blood clots and stroke, the drug maker said on Source: www.reuters.com India's Strides Arcolab gets ANDA approval for rifampicin injection - Forbes MUMBAI (Thomson Financial) - Indian pharmaceutical company Strides Arcolab Ltd. said it received abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration for its rifampicin injection, an anti-tubercular agent. In a Source: www.forbes.com Labels: FDA FDA, Medicare to form early-warning drug network - Los Angeles Times FDA, Medicare to form early-warning drug network - Los Angeles Times
WASHINGTON -- Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced a joint venture Thursday that promises to improve prescription drug safety for all Americans, while potentially Source: www.latimes.com Wyeth Says FDA Requests Added Information On Drug - CNN Money Wyeth (WYE) said Friday that its pharmaceuticals division received an approvable letter from the Food and Drug Administration for bazedoxifene, a treatment for postmenopausal osteoporosis. The Madison, N.J. , drugmaker said that in the letter, the Source: money.cnn.com Labels: FDA FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. FDA Approves Amitiza for IBS-C The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23) WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. Labels: FDA FDA approves GlaxoSmithKline drug - MSN MoneyCentral FDA approves GlaxoSmithKline drug - MSN MoneyCentral
The U.S. Food and Drug Administration on Tuesday night approved the GlaxoSmithKline drug Entereg, designed to help patients regain gastrointestinal function earlier after bowel surgery. The condition the drug was developed to treat, known as Source: news.moneycentral.msn.com Labels: FDA Medicare database to flag drug problems - Lexington Herald-Leader Medicare database to flag drug problems - Lexington Herald-Leader
Federal health officials will begin monitoring prescription drug usage by millions of Medicare participants in an effort to identify potential safety problems. The Food and Drug Administration has been under increasing pressure to develop a Source: www.kentucky.com Drug watch to monitor millions - Chicago Tribune WASHINGTON — Federal health officials will begin monitoring prescription drug usage by millions of Medicare participants in an effort to identify potential safety problems. The Food and Drug Administration has been under increasing pressure to Source: www.chicagotribune.com Medicare to help find drug effects - Boston Globe WASHINGTON - US regulators said they will use patient information from Medicare and other sources to monitor harmful side effects of drugs and medical devices to more quickly detect dangers once products are on the market. The Food and Drug Source: www.boston.com Labels: FDA May 22, 2008Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. Labels: FDA Gilbert company prime for 'sweet success' - AZCentral.com Gilbert company prime for 'sweet success' - AZCentral.com
A Gilbert company beat several food industry giants in the race to meet federal requirements to sell a new kind of sweetener. Two independent groups of scientists have certified that Wisdom Natural Brands' new SweetLeaf Stevia product is safe for use Source: www.azcentral.com Merck halts cholesterol drug study - CNN Money TRENTON, N.J. (AP) -- Merck & Co. has halted a study of an experimental drug it had touted as key to energizing its sagging cholesterol franchise, barely 3 weeks after U.S. regulators refused to allow sales of the drug. The drugmaker said Wednesday Source: money.cnn.com New safety program to monitor Medicare drug use - San Francisco Gate Federal health officials will begin monitoring prescription drug usage by millions of Medicare participants in an effort to identify potential safety problems. The Food and Drug Administration has been under increasing pressure to develop a Source: www.sfgate.com Wyeth, Nycomed sue Novartis' Sandoz over heartburn drug - Reuters India REUTERS - Drugmaker Wyeth and its partner Nycomed filed a patent infringement lawsuit against a unit of Novartis AG that sought U.S. Food and Drug Administration approval for a generic version of the heartburn drug Protonix, court papers show Source: in.reuters.com Kindler's Struggles Intensify on Pill's Suicide Link (Update4) - Bloomberg May 22 (Bloomberg) -- Sales of Pfizer Inc.'s quit-smoking pill Chantix are plummeting in the U.S. after regulators tied the drug to suicides, a setback that may depress shares beyond today's 11-year low. U.S. prescriptions for Chantix have dropped by Source: www.bloomberg.com Veterans' benefits bill wins approval in Senate - International Herald Tribune WASHINGTON : Twenty-five Republican senators broke with President George W. Bush and voted Thursday for a major expansion of veterans' benefits as part of a bill to finance another year of the wars in Iraq and Afghanistan. The proposal, adopted by a Source: www.iht.com Report on Pfizer's smoking-cessation drug raises safety questions - Forbes SAN FRANCISCO (Thomson Financial) - A new report by a watchdog group has highlighted serious side effects possibly linked to Pfizer Inc. 's smoking-cessation drug, Chantix, including heart trouble, seizures and diabetes, according to a media report Source: www.forbes.com FDA OKs Adolor, GlaxoSmithKline drug Entereg - MSN MoneyCentral The Food and Drug Administration Tuesday night approved Adolor Corp.'s Entereg drug that's designed to help patients regain gastrointestinal function earlier following bowel resection surgery. The condition the drug was developed to treat, known as Source: news.moneycentral.msn.com Labels: FDA Start at the Store: 7 Ways to Prevent Foodborne Illness Start at the Store: 7 Ways to Prevent Foodborne Illness
Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Drug Approved for Irritable Bowel Syndrome with Constipation FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over Strengthening Beef Safety An FDA regulation further protects consumers of beef against mad cow disease. Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Covidien now has Lymphazurin 1% injection available. FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. FDA Approves New Formulation of Coagulation Therapy he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. Labels: FDA FDA Approvals: Taclonex Scalp, Abilify, Levaquin CME - Medscape News FDA Approvals: Taclonex Scalp, Abilify, Levaquin CME - Medscape News
Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s) ™ for physicians; Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians To participate in this internet activity: (1) review the target audience, learning objectives, and Source: www.medscape.com FDA to Get Access to Medicare Part D Data - WebMD May 22, 2008 -- The FDA will soon start monitoring massive amounts of Medicare’s medical records in an effort to more closely monitor drug safety under new rules set by the Bush administration, federal officials said Thursday. The new rules will Source: www.webmd.com FDA unveils plan for drug, device safety tracking - Reuters WASHINGTON (Reuters) - U.S. health officials on Thursday announced plans for a new computer tracking system designed to help officials identify dangers from prescription drugs and medical devices after they reach the market. The proposal would enable Source: www.reuters.com U.S. health officials get tools to monitor drug safety - Chicago Tribune WASHINGTON — Federal health officials will use new regulatory authority to monitor prescription drug usage by millions Medicare participants for potential safety problems with medicines and medical devices. The Food and Drug Administration has been Source: www.chicagotribune.com Medicare Data to Be Used to Monitor Drug Side Effects (Update3) - Bloomberg May 22 (Bloomberg) -- U.S. regulators said they will use patient information from Medicare and other sources to monitor harmful side effects of drugs and medical devices and more quickly detect dangers once products are on the market. The Food and Source: www.bloomberg.com FDA unveils plan to monitor drug safety - MSNBC Federal health officials are getting new authority to mine prescription drug usage by millions of participants in the Medicare drug program to look for safety problems with medicines and medical devices after they hit the market. The Food and Drug Source: www.msnbc.msn.com U.S. unveils plan for drug, device safety tracking - Reuters WASHINGTON (Reuters) - U.S. health officials on Thursday announced plans for a new computer tracking system designed to help them identify dangers from prescription drugs and medical devices already on the market. The U.S. Food and Drug Source: www.reuters.com eHealth Initiative's Drug Safety Collaboration to Partner With FDA on - PR Newswire eHI's multi-stakeholder "Connecting Communities for Drug Safety Collaboration" conducting drug safety pilots to test and evaluate use of electronic health information to support post-market monitoring efforts WASHINGTON , May 22 /PRNewswire Source: sev.prnewswire.com New Efforts to Help Improve Medical Products for Patient Safety and - Forbes WASHINGTON, May 22 /PRNewswire-USNewswire/ -- HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve Source: www.forbes.com Labels: FDA Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue)
Covidien now has Lymphazurin 1% injection available. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11) Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites. DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx� Stent Graft System In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx� Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ... Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. Labels: FDA Civil Penalties Sought Against Maker of Hearing Aid Civil Penalties Sought Against Maker of Hearing Aid
A hearing aid manufacturer breaks the law, and FDA is seeking more than $2 million in penalties A Guide to Drug Safety Terms at FDA This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug. Labels: FDA FDA to get tool to monitor drug safety - WSLS FDA to get tool to monitor drug safety - WSLS
WASHINGTON (AP) - Federal health officials will mine prescription drug usage by millions of participants in the Medicare drug program to look for problems with medicines and medical devices after they hit the market. The Food and Drug Administration Source: www.wsls.com Labels: FDA Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)
Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate. Current Drug Shortage: Neupro (rotigotine transdermal system) UCB is preparing to recall all Neupro lots in the U.S. by May 2008 DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23) The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes). Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. Labels: FDA F.A.A. Bans Antismoking Drug, Citing Side Effects - The Ledger F.A.A. Bans Antismoking Drug, Citing Side Effects - The Ledger
The Federal Aviation Administration said Wednesday it would no longer permit pilots or air traffic controllers to use the smoking cessation drug Chantix, citing potential side effects that could pose a threat to the safe operation of aircraft. The Source: www.theledger.com FAA Bans Chantix Drug For Pilots, Controllers - Hartford Courant WASHINGTON — - The Federal Aviation Administration on Wednesday banned pilots and air traffic controllers from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other mishaps that posed Source: www.courant.com FAA bans anti-smoking drug - Seattle Times WASHINGTON — The Federal Aviation Administration (FAA) on Wednesday banned pilots and air traffic controllers from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other mishaps that Source: seattletimes.nwsource.com FAA bans Chantix drug - Baltimore Sun WASHINGTON - The Federal Aviation Administration banned pilots and air traffic controllers yesterday from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other mishaps that posed risks to Source: www.baltimoresun.com Anti-smoking drug banned for U.S. pilots - International Herald Tribune The U.S. Federal Aviation Administration is no longer permitting pilots or air traffic controllers to use the smoking cessation drug Chantix, citing potential side effects that could pose a threat to the safe operation of aircraft. Another federal Source: www.iht.com Kindler's Struggles Intensify on Pill's Suicide Link (Update1) - Bloomberg May 22 (Bloomberg) -- Sales of Pfizer Inc.'s quit-smoking pill Chantix are plummeting in the U.S. after regulators tied the drug to suicides, a setback that may further depress shares that reached a 10-year low a month ago. U.S. prescriptions for Source: www.bloomberg.com FAA Bans Chantix for Pilots, Drug Linked to Vision, Heart Problems - FOX News Pfizer Inc.'s once promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic Source: www.foxnews.com DOR BioPharma Provides Update on orBec(R) European Regulatory and - MSN MoneyCentral DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments, serious gastrointestinal diseases and vaccines against certain Source: news.moneycentral.msn.com Wyeth, Progenics drug misses goal in late-stage trial - BusinessWeek Wyeth and Progenics Pharmaceuticals Inc. said Thursday that early results from a late-stage trial of their drug Relistor did not meet its goal in restoring gastrointestinal function following surgery to the intestine. The study, in a condition known Source: www.businessweek.com Labels: FDA Heparin Sodium Injection Heparin Sodium Injection
Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. Labels: FDA Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2)
Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Labels: FDA Covidien gets FDA approval for surgery kit - Forbes Covidien gets FDA approval for surgery kit - Forbes
Medical device maker and diversified health care company Covidien Ltd. said Tuesday that the Food and Drug Administration granted approval to market a surgery kit for use in laparoscopic procedures. Covidien's SILS Procedure Kits can be used by Source: www.forbes.com Report Links Pfizer Drug To Accidents, Heart Trouble - Wall Street Journal A nonprofit drug safety group is raising concerns about serious side effects newly linked to Pfizer Inc.'s popular smoking-cessation medicine, Chantix, casting a pall over a drug already dogged by psychiatric issues and focusing the spotlight anew on Source: online.wsj.com The FDA's Cancer Chief Speaks Out - BusinessWeek Dr. Richard Pazdur, 55, is one of the most powerful men in medicine. An oncologist by training, he has overseen the U.S. Food & Drug Administration's cancer drug division since 1999, and in 2005 was named director of the FDA's newly created Office of Source: www.businessweek.com FAA bans Chantix drug - Baltimore Sun WASHINGTON - The Federal Aviation Administration banned pilots and air traffic controllers yesterday from using a popular anti-smoking drug after a study found that it had apparently contributed to auto accidents and other mishaps that posed risks to Source: www.baltimoresun.com FDA seeks new hepatitis blood donation rules - Reuters WASHINGTON (Reuters) - U.S. health officials are seeking to relax blood donation rules for some people who initially tested positive for hepatitis B, which could clear hundred of thousands of new donors, according to documents released on Tuesday Source: www.reuters.com Lutheran implants lighter artificial heart - Fort Wayne Journal Gazette A Middlebury man became the first in the region to receive a new, lighter partial artificial heart approved by the FDA last month, Lutheran Hospital said today. Gary Snearey, 61, was said to be recovering well after having the Thoratec HeartMate II Source: www.journalgazette.net New Survey Suggests That Consumers Are Naive to the Risk of Botox - Forbes Survey also reveals less than 5% trust magazines or advertising for treatment information NEW YORK , May 20 /PRNewswire-USNewswire/ -- The Physicians Coalition for Injectable Safety (http://www.injectablesafety.org) and the health and beauty Source: www.forbes.com Lasik patient welcomes tougher look at surgery - Nashville Tennessean Everything Gerry Schmidt sees is splattered with little black dots and swiggly lines. He sometimes has double vision. And at night, headlights look like blinding miniature suns. Before undergoing Lasik corrective-vision surgery last year, Schmidt Source: www.tennessean.com Pro-Pharmaceuticals Announces Submission of Drug Master File for - MSN MoneyCentral Pro-Pharmaceuticals, Inc. PRW , a Company developing carbohydrate-based targeted therapeutic compounds to treat cancer and fibrosis, has completed an important step toward submission of a New Drug Application (NDA) for DAVANAT(R) by filing the Drug Source: news.moneycentral.msn.com Labels: FDA May 21, 2008SkyWest Unit Gets FDA Warning Letter - CNN Money SkyWest Unit Gets FDA Warning Letter - CNN Money
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has sent a letter to a unit of Skywest Inc. (SKYW), Atlantic Southeast Airlines, saying it found equipment at the company's Wichita, Kan ., watering plant that wasn't properly sanitized Source: money.cnn.com FDA approves Entereg, Adolor's first medication - Philiy.com Adolor Corp. and GlaxoSmithKline P.L.C. won a four-year struggle yesterday to sell the first U.S. treatment for constipation after intestinal surgery. The Food and Drug Administration approved a seven-day regimen of the medicine, Entereg, for Source: www.philly.com Study sees Pfizer smoking drug risk, shares fall - Forbes WASHINGTON (Reuters) - Hundreds of patients taking Pfizer Inc (nyse: PFE - news - people )'s anti-smoking drug Chantix have reported serious accidents, vision problems and heart trouble, researchers said Wednesday, sending shares of the world's Source: www.forbes.com Cancer's Cruel Economics - BusinessWeek Editor's note: For a CBS Evening News report on the challenges confronting new cancer drug approvals, which was made in collaboration with BusinessWeek , click here . Dr. Oleg Loran treats kidney cancer, but he doesn't have much to offer his patients Source: www.businessweek.com Labels: FDA American Oriental Bioengineering Forms Science and Technology Advisory - MSN MoneyCentral American Oriental Bioengineering Forms Science and Technology Advisory - MSN MoneyCentral
- Committee To Discuss AOBO's Long-Term Growth Strategy - - First Annual Meeting Held in Beijing Today - NEW YORK, May 20 /PRNewswire-FirstCall/ -- American Oriental Bioengineering, Inc. AOB ("AOB" or "the Company"), a pharmaceutical company Source: news.moneycentral.msn.com Adolor, GlaxoSmithKline receive FDA Approval for bowel drug Entereg - RTT News (RTTNews) - Adolor Corp. (ADLR: News, Chart, Quote ) and GlaxoSmithKline (GSK: News, Chart, Quote ) said Tuesday that the U.S. Food and Drug Administration has approved their bowel drug Entereg to help patients regain gastrointestinal (GI) function Source: www.rttnews.com InterMune shares rise on FDA drug designation - CNBC NEW YORK - Shares of InterMune Inc. rose Monday after the Food and Drug Administration gave the biotechnology company's developing lung disease treatment fast-track status, allowing for a quicker regulatory review. The stock gained 55 cents, or 3.7 Source: www.cnbc.com U.S. warns SkyWest unit over dirty water facility - Reuters WASHINGTON (Reuters) - U.S. health regulators have warned SkyWest Inc's Atlantic Southeast Airlines unit after inspectors found paint chips and other debris in drinking water equipment, according to a letter from the regulators released on Tuesday. U Source: www.reuters.com Advaxis Files Investigational New Drug Application with U.S. Food and - Genetic Engineering News Advaxis Inc., ( OTCBB: ADXS , http://www.advaxis.com.), a developmental biotechnology company, completed its filing of a new investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA"). This filing follows the Source: www.genengnews.com Pro-Pharmaceuticals Announces Submission of Drug Master File for - Phramalive.com NEWTON, Mass.--(BUSINESS WIRE)--May 20, 2008 - Pro-Pharmaceuticals, Inc. (Amex: PRW), a Company developing carbohydrate-based targeted therapeutic compounds to treat cancer and fibrosis, has completed an important step toward submission of a New Drug Source: www.pharmalive.com SkyWest Unit Gets FDA Warning Letter - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has sent a letter to a unit of Skywest Inc. (SKYW), Atlantic Southeast Airlines, saying it found equipment at the company's Wichita, Kan ., watering plant that wasn't properly sanitized Source: money.cnn.com OFFICIAL-Heart polypill to start clinical tests - Forbes LONDON, May 19 (Reuters) - Spanish researchers are to start clinical testing of a three-in-one pill to prevent heart attacks, which they hope to launch worldwide in 2010 for less than $10 a month. The first European patients will begin taking the so Source: www.forbes.com Covidien gets FDA clearance to market laparoscopic surgery procedure - CNBC BOSTON (Thomson Financial) - Covidien Ltd. Tuesday said it has received clearance from the Food and Drug Administration to market its single-incision laparoscopic surgery procedure kit. The company said the devices in the kit can be used by surgeons Source: www.cnbc.com Covidien gets FDA approval for surgery kit - Forbes Medical device maker and diversified health care company Covidien Ltd. said Tuesday that the Food and Drug Administration granted approval to market a surgery kit for use in laparoscopic procedures. Covidien's SILS Procedure Kits can be used by Source: www.forbes.com Labels: FDA FDA Approves New Formulation of Coagulation Therapy FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. FDA Orders Pet Food Maker to Obtain Emergency Operating Permit The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce. Device Identifies Fatty Deposits in Coronary Arteries A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Labels: FDA Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov FDA approves Entereg to help restore bowel function following surgery FDA approves Entereg (alvimopan) to help restore bowel function following surgery Source: www.fda.gov Labels: FDA May 20, 2008FDA Approves Entereg to Help Restore Bowel Function Following Surgery FDA Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Source: www.fda.gov Labels: FDA Cooperative Agreement to Support the World Health Organization (WHO) International Programme on Chemical Safety (IPCS) Cooperative Agreement to Support the World Health Organization (WHO) International Programme on Chemical Safety (IPCS)
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement, a new Sole Source, Competitive Continuation in fiscal year 2008 to the World Health Organization (WHO) International Programme on Chemical Safety (IPCS). Source: www.cfsan.fda.gov Labels: FDA FDA Drugstore.com |
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