August 30, 2008For Tillman, family come first - Chicago Tribune For Tillman, family come first - Chicago Tribune
Charles Tillman was arrested for driving under the influence and faces jail time. Charles Tillman was involved in a domestic dispute. Charles Tillman failed a drug test. Name a rumor and either Tillman or his wife, Jackie, likely read it this summer Source: www.chicagotribune.com India Dr Reddy's gets FDA nod for trandolapril tabs - CNBC MUMBAI, Aug 29 (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd Source: www.cnbc.com Concerns remain as salmonella outbreak comes to an end - Los Angeles Times Four months after an outbreak of salmonella hospitalized hundreds, forced groceries to toss out of tomatoes and peppers by the thousands, infuriated fruit and vegetable growers and puzzled consumers, health authorities said Thursday that the epidemic Source: www.latimes.com CDC: Salmonella Outbreak Over, Source May Never Be Known - FOX News CDC: Salmonella Outbreak Over, Source May Never Be Known - FOX News
The government said Thursday that the salmonella outbreak that sickened at least 1,440 people appears to be over, but its ultimate source may never be known, partly because of shortcomings in the nation's food safety system. The Centers for Disease Source: www.foxnews.com Dr Reddy's gets FDA nod for trandolapril tabs - Reuters India MUMBAI (Reuters) - Indian drug maker Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for trandolapril tablets, the regulator's website showed. The drug is a generic version of Abbott Laboratories' Mavik Source: in.reuters.com FDA clears Mexico peppers - Miami Herald The federal government on Thursday declared an end to the salmonella outbreak that sickened 1,442 people, yet still refused to exonerate Florida tomatoes. The Food and Drug Administration also said it's safe for consumers to resume eating jalapeño Source: www.miamiherald.com Salmonella outbreak likely over, CDC says - Detroit News WASHINGTON -- The government said Thursday that the salmonella outbreak that sickened at least 1,440 people appears to be over, but its ultimate source may never be known, partly because of shortcomings in the nation's food safety system. The Centers Source: www.detnews.com ACC Applauds California's Decision to Not Ban Food-Contact Products - CNBC ARLINGTON, Va., Aug 30, 2008 /PRNewswire-USNewswire via COMTEX/ -- The American Chemistry Council (ACC) applauds the California Assembly for listening to scientific experts and not passing SB1713 -- a bill that would have needlessly removed safe and Source: www.cnbc.com Concerns remain as salmonella outbreak comes to an end - Los Angeles Times Four months after an outbreak of salmonella hospitalized hundreds, forced groceries to toss out of tomatoes and peppers by the thousands, infuriated fruit and vegetable growers and puzzled consumers, health authorities said Thursday that the epidemic Source: www.latimes.com Stent Probe Undermines J&J, Abbott, Boston Scientific (Update1) - Bloomberg Aug. 29 (Bloomberg) -- A $1.8 billion market for metal tubes used to clear blocked arteries outside the heart may be upended by a U.S. probe into marketing practices by Johnson & Johnson , Boston Scientific Corp. and Abbott Laboratories. The Food and Source: www.bloomberg.com Debate over food irradiation still simmering - Minneapolis Star Tribune A fter two years of nearly constant food-borne illness outbreaks and recalls of everything from tainted peanut butter to tons of hamburger meat, the Food and Drug Administration's decision this month to allow the irradiation of lettuce and spinach to Source: www.startribune.com For Tillman, family come first - Chicago Tribune Charles Tillman was arrested for driving under the influence and faces jail time. Charles Tillman was involved in a domestic dispute. Charles Tillman failed a drug test. Name a rumor and either Tillman or his wife, Jackie, likely read it this summer Source: www.chicagotribune.com India Dr Reddy's gets FDA nod for trandolapril tabs - CNBC MUMBAI, Aug 29 (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd Source: www.cnbc.com FDA official says plastic chemicals are safe to children - Food Consumer FDA official says plastic chemicals are safe to children - Food Consumer
WEDNESDAY Aug 30, 2008 (foodconsumer.org) -- A federal health official said yesterday June 10 that plastic baby bottles and water bottles are safe to use and would not cause any harm to infants and young children. Bay bottles and water bottles Source: foodconsumer.org CDC: Salmonella outbreak appears to be over - Miami Herald WASHINGTON The government said Thursday that the salmonella outbreak that sickened at least 1,440 people appears to be over, but its ultimate source may never be known, partly because of shortcomings in the nation's food safety system. The Centers Source: www.miamiherald.com ACC Applauds California's Decision to Not Ban Food-Contact Products - Forbes ARLINGTON, Va., Aug. 30 /PRNewswire-USNewswire/ -- The American Chemistry Council (ACC) applauds the California Assembly for listening to scientific experts and not passing SB1713 -- a bill that would have needlessly removed safe and essential Source: www.forbes.com Salmonella Outbreak Over, U.S. Says - Forbes Salmonella Outbreak Over, U.S. Says - Forbes
THURSDAY, Aug. 28 (HealthDay News) -- U.S. health officials declared Thursday that the nationwide salmonella outbreak has ended and that the consumer advisory against eating raw jalapeno and serrano peppers grown in Mexico has been lifted. "Based on Source: www.forbes.com Fitch: Proposed FDA Regulation Could Reshape the U.S. Tobacco Industry - Forbes Fitch Ratings believes there is a strong likelihood that tobacco production and marketing will become regulated and that legislation granting the Food and Drug Administration (FDA) regulatory authority has the potential to alter the tobacco industry Source: www.forbes.com The CDC and FDA Announce That the Salmonella Outbreak is Over - eNews 2.0 Starting April 1, this year, Salmonella Saintpaul has sickened 1, 440 people and about 242 were hospitalized. The Food and Drug administration has tried to discover the produce infected since then. At first, tomatoes were accused to contain the virus Source: www.enews20.com India Dr Reddy's gets FDA nod for trandolapril tabs - CNBC MUMBAI, Aug 29 (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd Source: www.cnbc.com FDA approves irradiation for produce - AG Weekly WASHINGTON - The Food and Drug Administration issued a regulation on Friday allowing spinach and lettuce sellers to irradiate their produce to kill bacteria such as E. coli., a long-awaited move amid increasing outbreaks from raw produce. It doesn Source: www.agweekly.com Salmonella Outbreak Linked to Peppers Appears Over (Update2) - Bloomberg Aug. 28 (Bloomberg) -- The largest outbreak of food poisoning in a decade appears to have ended and consumers can resume eating Mexican jalapeno and serrano peppers, U.S. health officials said. The outbreak of salmonella , linked to peppers and Source: www.bloomberg.com CDC: Salmonella outbreak appears to be over - Miami Herald WASHINGTON The government said Thursday that the salmonella outbreak that sickened at least 1,440 people appears to be over, but its ultimate source may never be known, partly because of shortcomings in the nation's food safety system. The Centers Source: www.miamiherald.com Fitch: FDA control of tobacco may reshape industry - MSN MoneyCentral CHICAGO (AP) - If legislation passes to give the Food and Drug Administration the authority the regulate the tobacco industry, it could reshape the industry's competitive landscape, Fitch Ratings said in a new report Thursday. The U.S. House Source: news.moneycentral.msn.com Possible links to 6 deaths won?t stop all from taking Byetta - Middletown Journal Possible links to 6 deaths won?t stop all from taking Byetta - Middletown Journal
At least six patient deaths have been linked to Byetta, a version of a diabetes drug Amylin Pharmaceuticals manufactures. Dave Knodel of Butler County, who takes Byetta and has had minimal side-effects, said he will continue to take the injectable Source: www.middletownjournal.com Living with Fibromyalgia, Drugs Approved to Manage Pain Living with Fibromyalgia, Drugs Approved to Manage Pain
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Drug Shortage: Fentanyl transdermal patch Availability information updated. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. August 29, 2008Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage July 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. FDA Clears Test to Help Doctors Manage Heart Transplant Patients The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Vivitrol (naltrexone) Vivitrol (naltrexone)
Serious injection site reactions may occur with the use of injectable naltrexone. Byetta (exenatide) UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28) Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL". Manufacturer for Publix Brand Vanilla Wafers Issues a Recall for Undeclared Soy (August 15) The manufacturer of Publix Vanilla Wafers is recalling a limited number of 12oz boxes of Vanilla Wafers with a code date of 030409A as they may contain undeclared soy. Persons who have an allergy to soy run the risk of a serious or possible life-threatening allergic reaction if they consume the affected product. The UPC number may be found on the side label below the Nutrition Facts panel: Publix Vanilla Wafers, UPC: 41415-00609 QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28) Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21)
The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12) The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites FDA OKs blood test for heart transplant rejection - Miami Herald FDA OKs blood test for heart transplant rejection - Miami Herald
Government regulators on Wednesday cleared the way for broader use of a blood test that can spare heart transplant patients the ordeal of repeated biopsies to check if their bodies are rejecting the new organ. The Food and Drug Administration said Source: www.miamiherald.com Dr Reddy's gets FDA nod for trandolapril tabs - Reuters India MUMBAI (Reuters) - Indian drug maker Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for trandolapril tablets, the regulator's website showed. The drug is a generic version of Abbott Laboratories' Mavik Source: in.reuters.com Bristol-Myers shares dip on failed drug study - BusinessWeek Shares of Bristol-Myers Squibb Co. dipped Wednesday after the drug developer said its developing blood thinner apixaban failed in a late-stage study. The stock fell 46 cents, or 2.1 percent, to $21.52. Shares have traded between $19.43 and $30.35 Source: www.businessweek.com XDx's AlloMap(R) Gene Expression Test Cleared by U.S. Food and Drug - Forbes XDx, Inc. has received market clearance from the U.S. Food and Drug Administration (FDA) for AlloMap(R) Molecular Expression Testing. The AlloMap Test is a noninvasive, multi-gene molecular diagnostics blood test used to aid in the identification of Source: www.forbes.com August 28, 2008FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. Drug Shortage: Fentanyl transdermal patch Availability information updated. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. Drug Shortage: MVI Adult Injectable Hospira information updated. FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant... FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. July 2008 Monthly Safety Labeling July 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Vivitrol (naltrexone) Serious injection site reactions may occur with the use of injectable naltrexone. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection See Web site for additional information on this current drug shortage Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Teva Says Parkinson's Drug Is First to Slow Disease (Update2) - Bloomberg Teva Says Parkinson's Drug Is First to Slow Disease (Update2) - Bloomberg
Aug. 26 (Bloomberg) -- Teva Pharmaceutical Industries Ltd . said its Azilect pill is the first to slow the progression of Parkinson's disease in new findings that may increase sales of the medicine to more than $1 billion. Patients who took the 1 Source: www.bloomberg.com Slow Acceptance Of Food Irradiation Method Seen By Producers - All Headline News Washington, D.C. (AHN) - The new U.S. Food and Drug Administration law permitting the use of irradiation on spinach and iceberg lettuce will take some time before it will be practiced widely across the country. According to David Gombas, senior vice Source: www.allheadlinenews.com J&J Schizophrenia Drug Faces FDA Delay - Street.Com Johnson & Johnson JNJ said late Tuesday that the Food and Drug Administration asked it for additional data before it will approve its paliperidone palmitate, an investigational once-monthly intramuscular injection for schizophrenia. The company Source: www.thestreet.com FDA OKs blood test for heart transplant rejection - Miami Herald Government regulators on Wednesday cleared the way for broader use of a blood test that can spare heart transplant patients the ordeal of repeated biopsies to check if their bodies are rejecting the new organ. The Food and Drug Administration said Source: www.miamiherald.com U.S. seeks more data for J&J schizophrenia drug - Reuters WASHINGTON, Aug 26 (Reuters) - U.S. health regulators have called for more data before deciding whether a Johnson & Johnson (JNJ.N: Quote , Profile , Research , Stock Buzz ) experimental schizophrenia drug could be sold on the U.S. market, the Source: www.reuters.com August 27, 2008FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA Law Enforcers Crack Down on Illegal Botox Scammer
FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. Drug Shortage: Fentanyl transdermal patch Availability information updated. Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses. FDA Law Enforcers Protect Consumers' Health Inside the FDA's Office of Criminial Investigations Warning on Certain Mussel Products from Bantry Bay Seafood FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)
UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. FDA Law Enforcers Protect Consumers' Health Inside the FDA's Office of Criminial Investigations FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage August 26, 2008Amylin reports four additional deaths with Byetta - Forbes Amylin reports four additional deaths with Byetta - Forbes
BOSTON (Reuters) - Amylin Pharmaceuticals Inc (nasdaq: AMLN - news - people ) said there have been four deaths among patients with pancreatitis who took its diabetes drug, Byetta, in addition to two deaths reported last week by U.S. regulators. The Source: www.forbes.com J&J Schizophrenia Drug Faces FDA Delay - Street.Com Johnson & Johnson JNJ said late Tuesday that the Food and Drug Administration asked it for additional data before it will approve its paliperidone palmitate, an investigational once-monthly intramuscular injection for schizophrenia. The company Source: www.thestreet.com FDA Asks J&J For More Data On Schizophrenia Drug - CNN Money The U.S. Food and Drug Administration has asked Johnson & Johnson (JNJ) for additional data before it will approve paliperidone palmitate, a schizophrenia drug. The agency outlined questions that need to be addressed but did not ask for additional Source: money.cnn.com FDA approves TomoTherapy's TomoDirect radiation therapy technology - RTT News (RTTNews) - TomoTherapy Inc. (TOMO: News ) announced on Tuesday that it has received 510(k) clearance from the US Food and Drug Administration, or the FDA, for its TomoDirect radiation therapy technology. TomoDirect is an innovative new discrete Source: www.rttnews.com UPDATE 1-Amylin to provide clarity on pancreatitis deaths - Reuters BOSTON, Aug 26 (Reuters) - The chief executive of Amylin Pharmaceuticals Inc (AMLN.O: Quote , Profile , Research , Stock Buzz ) said the purpose of a conference call later on Tuesday is to provide greater clarity around the deaths of several patients Source: www.reuters.com FDA Issues Complete Response Letter for Paliperidone Palmitate for the - Forbes TITUSVILLE, N.J., Aug. 26 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional data before it will approve the company's New Drug Source: www.forbes.com Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals
In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant... FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Tysabri (natalizumab) Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year. Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. FDA approves Amgen drug for some treatment of rare blood problem - MSN MoneyCentral FDA approves Amgen drug for some treatment of rare blood problem - MSN MoneyCentral
The Food and Drug Administration approved the Amgen Inc. drug Nplate. Thousand Oaks-based Amgen's (NASDAQ: AMGN) drug can now be sold in the United States as a treatment for a rare blood disorder, chronic immune thrombocytopenic purpura. The FDA said Source: news.moneycentral.msn.com Cancer Test for Women Raises Hope, and Concern - The Ledger A new blood test aimed at detecting ovarian cancer at an early, still treatable stage is stirring hopes among women and their physicians. But the Food and Drug Administration and some experts say the test has not been proved to work. The test, called Source: www.theledger.com Clear confusion from food allergy warnings - Montana Standard WASHINGTON — It's one of the biggest frustrations of life with food allergies: That hodgepodge of warnings that a food might accidentally contain the wrong ingredient. The warnings are voluntary — meaning there's no way to know if foods that don Source: www.mtstandard.com Fund set up for pet-food claims - Montgomery Advertiser Almost 6,000 claims have been filed in a class-action settlement stemming from last year's massive pet-food recall. Menu Foods, other pet-food makers and retailers in May agreed to set up a $24 million cash fund to compensate pet owners whose cats Source: www.montgomeryadvertiser.com FDA Approves First Bone Marrow Stimulator - Post Chronicle The U.S. Food and Drug Administration says it has approved Nplate (romiplostim), the first product that directly stimulates bone marrow platelet production. The FDA said the new drug will be used to produce needed platelets in patients with a rare Source: www.postchronicle.com Boston seeks help to lower small business energy costs - Boston Globe Boston officials have put out a "request for responses" from energy brokers or consultants interested in helping small businesses form an energy-buying group to reduce their natural gas and electricity costs. Businesses participating in the energy Source: www.boston.com When food labels confuse allergy issue - Philadelphia Daily News WASHINGTON - It's one of the biggest frustrations of life with food allergies: that hodgepodge of warnings that a food might accidentally contain the wrong ingredient. The warnings are voluntary - meaning there's no way to know if foods that don't Source: www.philly.com Fund set up for pet-food claims - Montgomery Advertiser Fund set up for pet-food claims - Montgomery Advertiser
Almost 6,000 claims have been filed in a class-action settlement stemming from last year's massive pet-food recall. Menu Foods, other pet-food makers and retailers in May agreed to set up a $24 million cash fund to compensate pet owners whose cats Source: www.montgomeryadvertiser.com FDA targets kids' cold medicine - Chicago Tribune WASHINGTON — The Food and Drug Administration on Friday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market. In response to rising Source: www.chicagotribune.com Clear confusion from food allergy warnings - Montana Standard WASHINGTON — It's one of the biggest frustrations of life with food allergies: That hodgepodge of warnings that a food might accidentally contain the wrong ingredient. The warnings are voluntary — meaning there's no way to know if foods that don Source: www.mtstandard.com FDA: Irradiating spinach, lettuce OK to kill germs - Newsday WASHINGTON - Consumers worried about salad safety may soon be able to buy fresh spinach and iceberg lettuce zapped with just enough radiation to kill E. coli and a few other germs. The Food and Drug Administration on Friday will issue a regulation Source: www.newsday.com FDA approves Amgen drug for some treatment of rare blood problem - MSN MoneyCentral The Food and Drug Administration approved the Amgen Inc. drug Nplate. Thousand Oaks-based Amgen's (NASDAQ: AMGN) drug can now be sold in the United States as a treatment for a rare blood disorder, chronic immune thrombocytopenic purpura. The FDA said Source: news.moneycentral.msn.com August 25, 2008Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21)
The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Manufacturer for Publix Brand Vanilla Wafers Issues a Recall for Undeclared Soy (August 15) The manufacturer of Publix Vanilla Wafers is recalling a limited number of 12oz boxes of Vanilla Wafers with a code date of 030409A as they may contain undeclared soy. Persons who have an allergy to soy run the risk of a serious or possible life-threatening allergic reaction if they consume the affected product. The UPC number may be found on the side label below the Nutrition Facts panel: Publix Vanilla Wafers, UPC: 41415-00609 FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. Fentanyl Transdermal System CII Patches UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13) The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label. FDA Targets Kids' Cold Medicine - Hartford Courant FDA Targets Kids' Cold Medicine - Hartford Courant
WASHINGTON — The Food and Drug Administration on Friday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market. In response to rising Source: www.courant.com Addiction Drug Can Also Treat Obesity - eMaxHealth.com Addiction treatment drug Vigabatrin is found to be good as obesity treatment. Vigabatrin is addiction drug, which took 20 years to be developed. It comes from scientists at the U.S. Department of Energy's (DOE) Brookhaven National Laboratory and now Source: www.emaxhealth.com FDA Extends Consumer Warning on Serrano Peppers from Mexico FDA Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. August 24, 2008FDA Targets Kids' Cold Medicine - Hartford Courant FDA Targets Kids' Cold Medicine - Hartford Courant
WASHINGTON — The Food and Drug Administration on Friday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market. In response to rising Source: www.courant.com Addiction Drug Can Also Treat Obesity - eMaxHealth.com Addiction treatment drug Vigabatrin is found to be good as obesity treatment. Vigabatrin is addiction drug, which took 20 years to be developed. It comes from scientists at the U.S. Department of Energy's (DOE) Brookhaven National Laboratory and now Source: www.emaxhealth.com FDA targets kids' cold medicine - Chicago Tribune WASHINGTON — The Food and Drug Administration on Friday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market. In response to rising Source: www.chicagotribune.com FDA to review cold medicine for kids - Seattle Times FDA to review cold medicine for kids - Seattle Times
WASHINGTON — The Food and Drug Administration (FDA) on Friday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market. As the first Source: seattletimes.nwsource.com FDA Approves Amgen Inc.'s Nplate Drug For The Fight Against ITP - Eflux Media On Friday, the Food and Drug Administration (FDA) gave its approval for Amgen Inc.'s drug called Nplate, therefore it will be made available for U.S. residents soon enough. The administration acknowledged the efficiency and lack of risks associated Source: www.efluxmedia.com FDA Allows Irradiation of Some Produce - Washington Post Food producers can now use radiation to kill bacteria on fresh spinach and iceberg lettuce because of a new Food and Drug Administration ruling meant to help head off outbreaks of foodborne illness. This is the first time the agency has allowed Source: www.washingtonpost.com FDA clears Amgen drug for blood-clotting disorder - San Diego Union-Tribune WASHINGTON – Federal regulators on Friday approved a biotech drug from Amgen Inc. to treat a rare blood-clotting disorder. The Food and Drug Administration approved Nplate for patients with a disorder that causes the body to attack its own Source: www.signonsandiego.com FDA investigates possible Vytorin link to cancer - Hanford Sentinel WASHINGTON - Federal drug safety regulators said Thursday they are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer. However, the Food and Drug Administration said patients should not stop Source: www.hanfordsentinel.com FDA: Vytorin Not Linked to Cancer Risk - Wall Street Journal Remember when we said the Vytorin-cancer thing had quickly faded from view ? Turns out it hasn’t disappeared altogether. The FDA said yesterday that preliminary data from two large, ongoing studies of Vytorin, a cholesterol drug sold by Merck and Source: blogs.wsj.com New FDA labeling rule could be lawsuit shield - San Diego Union-Tribune WASHINGTON – Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits. The regulations from the Food and Drug Administration Source: www.signonsandiego.com FDA Allows Irradiation of Some Produce - Washington Post FDA Allows Irradiation of Some Produce - Washington Post
Radiation can now be used to kill bacteria on some produce, including spinach, to help prevent foodborne illness. (By Marcio Jose Sanchez -- Associated Press) Food producers can now use radiation to kill bacteria on fresh spinach and iceberg lettuce Source: www.washingtonpost.com FDA to review cold medicine for kids - Seattle Times WASHINGTON — The Food and Drug Administration (FDA) on Friday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market. As the first Source: seattletimes.nwsource.com FDA approves Amgen's blood platelet booster - Reuters WASHINGTON (Reuters) - Amgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the U.S. Food and Drug Administration said on Friday in approving the product for U.S. sales. The injectable Source: www.reuters.com FDA investigates possible Vytorin link to cancer - Hanford Sentinel WASHINGTON - Federal drug safety regulators said Thursday they are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer. However, the Food and Drug Administration said patients should not stop Source: www.hanfordsentinel.com New FDA labeling rule could be lawsuit shield - San Diego Union-Tribune WASHINGTON – Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits. The regulations from the Food and Drug Administration Source: www.signonsandiego.com FDA: Vytorin Not Linked to Cancer Risk - Wall Street Journal Remember when we said the Vytorin-cancer thing had quickly faded from view ? Turns out it hasn’t disappeared altogether. The FDA said yesterday that preliminary data from two large, ongoing studies of Vytorin, a cholesterol drug sold by Merck and Source: blogs.wsj.com FDA to permit irradiation of spinach, lettuce - San Francisco Gate FDA to permit irradiation of spinach, lettuce - San Francisco Gate
Friday, August 22, 2008 The Food and Drug Administration is amending the food-additive regulations to provide what it calls the safe use of ionizing radiation for just the two leafy greens. The FDA also has received petitions seeking permission to Source: www.sfgate.com FDA approves irradiating spinach, lettuce to kill germs - Los Angeles Times The FDA determined that irradiation indeed can kill food-poisoning germs and even lengthen the greens' shelf life without compromising the safety or nutrient value of raw spinach and lettuce. The new regulation goes into effect Friday. The FDA says Source: www.latimes.com FDA Allows Irradiation of Some Produce - Washington Post Food producers can now use radiation to kill bacteria on fresh spinach and iceberg lettuce because of a new Food and Drug Administration ruling meant to help head off outbreaks of foodborne illness. This is the first time the agency has allowed Source: www.washingtonpost.com UPDATE 2-U.S. FDA approves Amgen's blood platelet booster - Reuters WASHINGTON, Aug 22 (Reuters) - Amgen Inc (AMGN.O: Quote , Profile , Research , Stock Buzz ) drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the U.S. Food and Drug Administration said on Source: www.reuters.com FDA investigates possible Vytorin link to cancer - AOL WASHINGTON -Federal drug safety regulators said Thursday they are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer. However, the Food and Drug Administration said patients should not stop Source: news.aol.com FDA Investigates Possible Vytorin-Cancer Link - HealthCentral.com Following the FDA's announcement Thursday about the possible Vytorin-cancer link, several Congressional lawmakers issued a demand for data on the trial that suggested a potential connection, the AP said. Merck and Schering-Plough said they would Source: www.healthcentral.com 2nd UPDATE:FDA Reviews Vytorin Studies,Yet To See Cancer Link - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said interim data from two large, ongoing trials involving the cholesterol- lowering drug Vytorin show no increased risk of cancer. The FDA is reviewing a recent study, called Source: money.cnn.com Safety and Food Packaging Safety and Food Packaging
FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. Warning on Certain Mussel Products from Bantry Bay Seafood FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage |
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