November 29, 2008FDA sets melamine standard for baby formula - Guardian Unlimited FDA sets melamine standard for baby formula - Guardian Unlimited
Associated Press Writers= WASHINGTON (AP) - Two months ago, federal food regulators said they were unable to set a safety threshold for the industrial chemical melamine in baby formula. Now, however, they found a way to settle on a standard that Source: www.guardian.co.uk Obama to broaden role of genetics in medical care - AOL The issue of getting the right treatment to the right person goes with his whole emphasis on health reform," said Mark McClellan, a noted Republican health care expert who served President George W. Bush as Medicare director and head of the Food and Source: news.aol.com Business news in brief: Daily Tribune to trim printing days - Detroit Free Press Business news in brief: Daily Tribune to trim printing days - Detroit Free Press
The suburban newspaper the Daily Tribune says it will cut its print edition to four days a week from six. The newspaper published in Royal Oak says it's a way to save money during difficult economic times. The newspaper will be published on Wednesday Source: www.freep.com What Happens if You Eat Dog Food? - LiveScience.com If you just eat a little bit of dog food, probably nothing will happen. But you don't really know that for sure because dog food is not subjected to the same health and safety regulations that human food is required to have. In the United States, the Source: www.livescience.com US sets limit for melamine in baby milk - South China Morning Post US regulators have set a safety threshold for the industrial chemical melamine in US-made infant formula. Food and Drug Administration officials on Friday set a threshold of one part per million of melamine in formula, provided a related chemical was Source: www.scmp.com FDA Opens Offices in Beijing, Guangzhou and Shanghai - Eflux Media The Food and Drug Administration has decided to take an important step when it comes to consumer safety. Thus, three offices will be opened in China this week. The FDA is taking measures to ensure the quality and safety of the products exported to Source: www.efluxmedia.com Pregnant, two kids under five and cancer. What would you do? - Guardian Unlimited Lizette Irvin, heavily pregnant, reclined on a hospital bed, relaxed, considering the circumstances. A bag of fluid dripped into her blood through an IV line as she sucked on ice cubes, trying to pass the time. The ice helped to minimise the metallic Source: www.guardian.co.uk US sets levels of melamine - Straits Times WASHINGTON - US HEALTH authorities have raised the safety threshold for melamine for infant formula amid widespread concern over the use of the industrial chemical in Chinese dairy products. Melamine is used to line cans, make flame retardant and Source: www.straitstimes.com Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection
See Web site for additional information Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. FDA Acts to Reduce Risk of Salmonella Infections Find out why pet turtles may be a health risk and how FDA is enforcing a ban on the small creatures. Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo... Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch
See Related information section Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information November 28, 2008FDA defends U.S. infant formula - Boston Globe FDA defends U.S. infant formula - Boston Globe
WASHINGTON (Reuters) - The U.S. Food and Drug Administration defended the safety of infant formula sold in the United States on Friday despite tests that found the chemical melamine in one brand and a related compound in another. The amounts found Source: www.boston.com Personalized medicine push - Grand Forks Herald WASHINGTON — For years, scientists have held out hope that the rapidly evolving field of genetics could transform medical diagnosis and treatment, moving beyond a trial-and-error approach as old as the Hippocratic Oath. But the vision of Source: www.grandforksherald.com FDA defends U.S. infant formula; sets safe level - Guardian Unlimited WASHINGTON, Nov 28 (Reuters) - The U.S. Food and Drug Administration defended the safety of infant formula sold in the United States on Friday despite tests that found the chemical melamine in one brand and a related compound in another. The amounts Source: www.guardian.co.uk Lilly withdraws Cymbalta chronic pain application - Miami Herald Lilly withdraws Cymbalta chronic pain application - Miami Herald
INDIANAPOLIS -- Drugmaker Eli Lilly and Co. withdrew an application to have its antidepressant Cymbalta approved as a treatment for chronic pain, but the company said Friday it will apply again in 2009. Eli Lilly had filed a supplemental new drug Source: www.miamiherald.com FDA Tips to Prevent Foodborne Illness This Holiday Season - Food Consumer The U. S. Food and Drug Administration (FDA) encourages consumers to pay special attention to the handling and preparation of foods during the upcoming holiday season. Keep in mind that the elderly, children, and individuals with weakened immune Source: foodconsumer.org Calls for national infant formula recall spread - Atlanta Journal Constitution Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer’s group and the Illinois attorney general demanding a Food and Drug Source: www.ajc.com Federal Trade Commission Discontinues Tar and Nicotine Test - Washington Post After 42 years, the U.S. Federal Trade Commission has ended a test to measure the amount of tar and nicotine in cigarettes. According to the Associated Press , the FTC decided to discontinue the testing for two reasons: the test itself was flawed Source: www.washingtonpost.com Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22)
Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. Glenmark recieves United States Food and Drug Administration (USFDA - New Kerala Glenmark recieves United States Food and Drug Administration (USFDA - New Kerala
New Delhi, Nov 21 : Glenmark Pharmaceuticals Ltd today said it has received approval from the United States Food and Drug Administration (USFDA) for distribution and marketing of Ranitidine tablets in the US market. Ranitidine tablets are used for Source: www.newkerala.com FDA Approves Epilepsy Drug - Post Chronicle The U.S. Food and Drug Administration has approved a new drug, rufinamide -- marketed as Banzel -- to treat severe epilepsy. The drug is to be used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome. "This approval offers Source: www.postchronicle.com FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid - Phramalive.com ROCKVILLE, Md., Nov. 20, 2008--The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. The approval will prevent a Source: www.pharmalive.com UPDATE 2-AstraZeneca infant lung drug faces U.S. delay - Reuters LONDON, Nov 28 (Reuters) - AstraZeneca Plc (AZN.L: Quote , Profile , Research , Stock Buzz ) faces a delay in getting a new infant lung drug from its recently acquired MedImmune biotech unit to market in the United States. The Anglo-Swedish drugmaker Source: www.reuters.com EDITORIAL: Around the world - Daily Freeman No comments posted. The U.S. Food and Drug Administration is still brooding over what to do about bisphenol A. That’s the omnipresent chemical that makes baby bottles tough and helps keep the inside of metal cans bacteria-free. But a cascade of Source: www.dailyfreeman.com FDA Approves New Drug For Severe Epilepsy - eMaxHealth.com The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome. "This approval offers another treatment option for patients who Source: www.emaxhealth.com Obama may tap Duke doctor - Raleigh News & Observer Some names being mentioned as candidates to head the Food and Drug Administration in the Obama administration include: * DR. ROBERT CALIFF, a cardiologist and vice chancellor for clinical research at Duke University * DR. STEVEN NISSEN, a Source: www.newsobserver.com UPDATE 1-AstraZeneca's motavizumab faces delay at U.S. FDA - Reuters LONDON, Nov 28 (Reuters) - AstraZeneca Plc (AZN.L: Quote , Profile , Research , Stock Buzz ) faces a delay in getting a new drug from its recently acquired MedImmune biotech unit to market in the United States. The Anglo-Swedish drugmaker said on Source: www.reuters.com November 27, 2008FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. FDA Approves New Drug to Treat Severe Form of Epilepsy The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome. FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Palm Beach drug injury lawyer on unsafe drugs - EIN News Palm Beach drug injury lawyer on unsafe drugs - EIN News
West Palm Beach drug injury lawyer, Susan Ramsey, injury attorney says Medicaid allows unsafe drugs. FDA unapproved drugs allows injuries and deaths. Medicaid, a division of the U.S. Government Centers for Medicare and Medicaid Services (CMS) http Source: www.einnews.com Calls for formula recall spread - Dubuque Telegraph Herald Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Food and Drug Source: www.thonline.com FDA finds more trace toxics in baby formula - CNN (CNN) -- Several samples of infant formula have tested positive for trace amounts of the toxic contaminant melamine or a related compound, the Food and Drug Administration said Thursday. More than 12,000 children have been hospitalized in China after Source: www.cnn.com Glaxo wins U.S. approval for platelet drug - Forbes NEW YORK, Nov 20 (Reuters) - GlaxoSmithKline Plc said on Thursday its new platelet-boosting drug, Promacta, had been granted accelerated approval by the U.S. Food and Drug Administration. Promacta, also known by the chemical name eltrombopag, is Source: www.forbes.com Calls for national infant formula recall spread - Cleveland Plain Dealer (AP) — Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Food Source: www.cleveland.com FDA Approves New Drug to Alleviate Moderate to Severe Pain FDA Approves New Drug to Alleviate Moderate to Severe Pain
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als... Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". Nordic shoppers not so merry this Christmas - Forbes Nordic shoppers not so merry this Christmas - Forbes
STOCKHOLM, Nov 26 (Reuters) - Households in the Nordic region plan to rein in spending on presents and food for the Christmas holidays as the financial crisis inspires growing caution among consumers, a survey showed on Wednesday. The survey of more Source: www.forbes.com Calls for national infant formula recall spread - WJLA Washington - Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Source: www.wjla.com Traces of Melamine Found in U.S Infant Formula - Eflux Media Small “trace amounts” of industrial and potentially toxic chemical melamine were detected in U.S.-produced infant formula. However experts say they pose little risk to children, if any. Associated Press investigative reporters obtained FDA Source: www.efluxmedia.com Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
See additional information in Related Information section. Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo... New from FDA: FDA?s Drug Safety Newsletter Now Available Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The Drug Safety Newsletter is one way ... Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Web site for additional information Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been ... Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als... Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions
An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ... Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14) Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products. Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classics Seasoned Tomato Sauce (November 20) Wegmans Food Markets, Inc. is initiating a voluntary recall of 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce with a "use-by- date of 11/26/08", UPC 77890 79010. November 26, 2008Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14) Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14)
Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Stop and Shop Recalls Butternut Squash in Prepared Turkey and Ham Dinner (November 24) Following a recall from its vendor, the Stop and Shop Supermarket Company has announced it is recalling all butternut squash sides that are packaged with the supermarket chain's prepared turkey and ham holiday dinners. Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Melamine found in U.S. baby formula - Lynchburg News and Advance Melamine found in U.S. baby formula - Lynchburg News and Advance
Traces of the industrial chemical melamine have been detected in samples of top-selling U.S. infant formula, but federal regulators insist the products are safe. The Food and Drug Administration said last month it was unable to identify any melamine Source: www.newsadvance.com UPDATE: Basilea Drug Ceftobiprole Faces Renewed FDA Delay - CNN Money ZURICH -(Dow Jones)- Swiss biotechnology firm Basilea Pharmaceutica AG ( BSLN.EB) said Wednesday that the U.S. Food and Drug Administration has further delayed approval of antibiotic ceftobiprole, after the regulator raised issues about data Source: money.cnn.com Barewa Pharmaceuticals shut after syrup kills 25 infants - Businessday Online Nigeria's drug administration agency has closed down a pharmaceuticals manufacturer in the commercial capital Lagos after contaminated teething syrup killed 25 infants and hospitalised at least 10 more. The National Agency for Food, Drug Source: www.businessdayonline.com FDA and industry detect traces of melamine in US-produced infant - Fremont News-Messenger Traces of the industrial chemical melamine have been detected in samples of top-selling U.S. infant formula, but federal regulators insist the products are safe. The Food and Drug Administration said last month it was unable to identify any melamine Source: www.thenews-messenger.com Traces of Melamine Found in US Infant Formula - Food Ingredients First Nov 26,2008 -The Food and Drug Administration (FDA) is insisting the formula is still safe for children, despite releasing previous statements that the agency could not identify any safe level of exposure to the chemical. 26/11/08 The US Food and Source: www.foodingredientsfirst.com FDA advisers recommend approval of new drug to treat gout - Canada East WASHINGTON - Government health advisers in the U.S. have recommended approval of the first new drug in 40 years for gout, a painful joint disease that mainly strikes middle-aged men. About five million people in the country suffer from gout, a form Source: www.canadaeast.com FDA rejects Johnson & Johnson infection treatment - Boston Globe NEW BRUNSWICK, N.J.— Johnson & Johnson said Wednesday the U.S. Food and Drug Administration rejected its new-drug application for ceftobiprole, an antibiotic for the treatment of complicated skin and skin-structure infections, including diabetic Source: www.boston.com 2nd UPDATE: Basilea Drug Ceftobiprole Faces Renewed FDA Delay - CNN Money ZURICH -(Dow Jones)- Swiss biotechnology firm Basilea Pharmaceutica AG ( BSLN.EB) said Wednesday that the U.S. Food and Drug Administration has further delayed approval of antibiotic ceftobiprole, after the regulator raised issues about data Source: money.cnn.com Cephalon (CEPH) and Eurand (EURX) File Infringement Suit Against Mylan - StreetInsider.com More News related to BRL Cephalon, Inc. (Nasdaq: CEPH ) and Eurand, Inc. (Nasdaq: EURX ) have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc. (NYSE: MYL ) and its subsidiary, Mylan, Inc., and Barr Source: www.streetinsider.com Melamine Traces Found in US-Made Infant Formula - Eflux Media China ’s tainted milk crisis that sickened thousands of babies across the country continues to spread fear in other parts of the world. The Food and Drug Administration said Tuesday it had discovered the toxic contaminant melamine in one sample of Source: www.efluxmedia.com PANOS Brands Recalls Vegan Rella Cheddar Block (November 21) PANOS Brands Recalls Vegan Rella Cheddar Block (November 21)
PANOS brands, of Saddle Brook, NJ is recalling Vegan Rella Cheddar Block, (a cheese substitute) with a Sell by date of 12/09/2008. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics) Potential increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen allele, HLA-B*1502. FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5) FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. November 25, 2008Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Web site for additional information Drug Shortages: Resolved Drug Shortages; Argatroban Injection See Related information section Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information New from FDA: FDA?s Drug Safety Newsletter Now Available Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The Drug Safety Newsletter is one way ... Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics) Potential increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen allele, HLA-B*1502. Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence. FDA has received nearly ... Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information November 24, 2008FDA Warns Public of Extortion Scam by FDA Impersonators FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. September 2008 Safety-Related Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Recalls and Safety Alerts: Serious Muscle Injury with Simvastatin/Amiodarone Combination FDA is reminding healthcare professionals that patients who take amiodarone along with drugs that contain simvastatin have an increased risk of rhabdomyolysis, a type of muscle injury that can lead to kidney failure and death. Amiodarone is an antia... November 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien) Recall due to mislabeling that could lead to incorrect insulin dosing. Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence. FDA has received nearly ... Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Product recalled because some bottles of the product could include metal fragments.. Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator Class I recall because of unsupported claims. New from FDA: FDA?s Drug Safety Newsletter Now Available Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The Drug Safety Newsletter is one way ... Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg) Generic products recalled because of the potential for oversized tablets that could cause serious or life-threatening consequences. False cancer cures - Global Nation False cancer cures - Global Nation
A few weeks ago, an international vendor of herbal products denounced the United States Federal Trade Commission (FTC) for launching what it described as “a campaign of terror against companies selling natural cures for cancer.” This allegation Source: globalnation.inquirer.net Labopharm's NDA for Novel Trazodone Formulation accepted for review by - StreetInsider.com LAVAL, QC, Nov. 24 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDS. ) today announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor Source: www.streetinsider.com Medicaid paying millions for unapproved drugs - Columbus Dispatch WASHINGTON (AP) -- Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are covered under Medicaid, an Associated Press analysis of federal data Source: www.dispatch.com Medicaid covering unapproved drugs - KVUE WASHINGTON – Taxpayers have shelled out at least $200 million since 2004 for medicines that have never been reviewed by the government for safety and effectiveness but still are covered under Medicaid, an Associated Press analysis of federal data Source: www.kvue.com FDA Panel Calls for Warnings on Wrinkle Fillers - Health and Age.com Last week, a US Food and Drug Administration (FDA) panel encouraged changes to product labels on popular cosmetic wrinkle treatments, such as Restylane® and Juvederm®, to warn consumers about scarring and other complications that can occur weeks or Source: www.healthandage.com AP IMPACT: Govt pays for deadly, unapproved drugs - WTOP Radio WASHINGTON (AP) - Dozens of deaths have been linked to medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid , an Associated Press analysis of federal data has found. Taxpayers Source: www.wtopnews.com November 23, 2008Group says FDA should reject Acorn’s device - Minneapolis-St Paul Business Journal Group says FDA should reject Acorn’s device - Minneapolis-St Paul Business Journal
A consumer group is urging federal regulators to deny Acorn Cardiovascular Inc. ’s request for approval to market its device for treating heart failure. New Brighton-based Acorn has struggled in recent years to win the government’s OK for the Source: twincities.bizjournals.com FDA To Review Safety Of Dermal Fillers, Wrinkle Reducers - dbtechno.com Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) is going to look over the safety of dermal fillers, which are often used by men and women to maintain a young appearance by reducing wrinkles. Dermal fillers come from many drug Source: www.dbtechno.com FDA to detain food shipments from China - Atlanta Journal Constitution Federal health officials on Thursday ordered dozens of imported foods from China held at the border as possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It’s unusual for the Food and Drug Administration to put Source: www.ajc.com Brand focus - Business Standard While the healthcare index has been quite resilient in the face of the equity meltdown dropping 28 per cent to Sensex’s 55 per cent over the last one year, some healthcare stocks have fallen quite sharply offering an attractive opportunity for Source: www.business-standard.com UPDATE 1-Targanta drug appears similar to rival-US FDA staff - Forbes NEW YORK, Nov 17 (Reuters) - Targanta Therapeutics Corp's clinical trial data show its antibiotic is about as safe and effective as another similar drug already on the U.S. market, Food and Drug Administration staff said on Monday. In general, the Source: www.forbes.com FDA to open China offices - KRQE News 13 BEIJING (AP) - The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares. The new FDA offices, which are the Source: www.krqe.com FDA rule tackling mad cow disease has side effects - Knoxville News Sentinel LITITZ, Pa. - A federal regulation aimed at preventing mad cow disease from getting into the food supply could create health risks of its own: many thousands of cattle carcasses rotting on farms, spreading germs, attracting vermin and polluting the Source: www.knoxnews.com AP IMPACT: Govt pays millions for unapproved drugs - Yahoo News WASHINGTON – Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data Source: news.yahoo.com Mylan Pharmaceuticals (MYL) Receives Tentative FDA Approval for - StreetInsider.com Mylan Pharmaceuticals (MYL) Receives Tentative FDA Approval for Generic Effexor XR Mylan Receives Tentative FDA Approval for the Generic Version of the Antidepressant Effexor XR(R) Morgan Stanley Starts Mylan (MYL) at Overweight Mylan's Dey L.P Source: www.streetinsider.com AP: Government pays millions for unapproved prescription drugs - Honolulu Advertiser AP: Government pays millions for unapproved prescription drugs - Honolulu Advertiser
WASHINGTON (AP) — Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal Source: www.honoluluadvertiser.com ULM professor, team developing pill to fight breast cancer - News-Star Get University of Louisiana at Monroe pharmacologist Paul Sylvester started talking about vitamin E and he’ll tell you all you ever wanted to know. He speaks with great brio about Vitamin E and with good reason: he believes he’s on the verge of a Source: www.thenewsstar.com Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)
Product recalled because some bottles of the product could include metal fragments.. November 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Recalls and Safety Alerts: Serious Muscle Injury with Simvastatin/Amiodarone Combination FDA is reminding healthcare professionals that patients who take amiodarone along with drugs that contain simvastatin have an increased risk of rhabdomyolysis, a type of muscle injury that can lead to kidney failure and death. Amiodarone is an antia... FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. PANOS Brands Recalls Vegan Rella Cheddar Block (November 21) PANOS brands, of Saddle Brook, NJ is recalling Vegan Rella Cheddar Block, (a cheese substitute) with a Sell by date of 12/09/2008. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. Nestle USA Voluntarily Recalls Two Production Codes of Nestle Nesquik Strawberry Powder (November 7) The recall only includes two (2) production codes of 21.8-ounce containers of Nestle Nesquik Strawberry Powder. Printed on the bottom of each plastic container is a production code of "82255880" or "82265880" with a best by date of "August 2010." Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14) Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14) Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14)
Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products. |
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