May 31, 2008May 2008 Patient Safety News May 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Xiadafil VIP Tablets Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. FDA requests more info on Wyeth's pneumonia drug - Forbes FDA requests more info on Wyeth's pneumonia drug - Forbes
Wyeth said Thursday the Food and Drug Administration will require more information on the safety and effectiveness of its antibiotic Tygacil in treating community-acquired pneumonia before granting approval. Tygacil is currently approved to treat Source: www.forbes.com Avastin Added to Chemo Helps Women With Advanced Breast Cancer - Atlanta Journal Constitution SATURDAY, May 31 (HealthDay News) -- Adding the drug Avastin to chemotherapy lengthened progression-free survival in women with advanced breast cancer, new research shows. Previous studies have found that adding Avastin (bevacizumab) to the Source: www.ajc.com FDA panel favors Glaxo, Ligand blood drug - San Francisco Gate Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline and Ligand Pharmaceuticals is effective for short-term use, despite reservations by FDA scientists. A panel of outside advisers voted unanimously in Source: www.sfgate.com Analyst: J&J blood-clot drug poised for success - CNBC NEW YORK - The anti-bloodclotting drug Rivaroxaban could help Johnson & Johnson fight off anticipated revenue losses from generic competition, according to a Deutsche Bank-North America analyst. The drug, which treats blood clots after orthopedic Source: www.cnbc.com Gilead buying hypertension drug from Navitas - CNN Money NEW YORK (Associated Press) - Biotechnology company Gilead Sciences Inc. said Thursday it will buy privately held Navitas Assets' hypertension treatment Cicletanine for an undisclosed amount, in a move to enhance its product pipeline. The drug is Source: money.cnn.com J&J blood clot drug beats Sanofi-Aventis' Lovenox - Boston Globe NEW YORK— Johnson & Johnson said Friday its experimental drug to treat blood clots after orthopedic surgery proved more effective in a late-stage trial than a competing drug from Sanofi- Aventis SA which is already on the market. Rivaroxaban, 10 Source: www.boston.com FDA panel favors Glaxo, Ligand blood drug - Los Angeles Times WASHINGTON -- Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: www.latimes.com FDA: Time for Asthma Patients to Get New Inhalers - ABC News FDA: Time for Asthma Patients to Get New Inhalers - ABC News
Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use inhalers that dispense Source: www.abcnews.go.com FDA panel favors Glaxo, Ligand blood drug - Forbes Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside advisers voted Source: www.forbes.com FDA panel says data backs use of Glaxo's Promacta - Forbes CHICAGO (Reuters) - An expert advisory panel to the U.S. Food and Drug Administration said Friday that current clinical data supports short-term use of GlaxoSmithKline (nyse: GSK - news - people ) Plc's experimental platelet-boosting drug, Promacta Source: www.forbes.com Tainted Drug Imports Set Off Warnings, Not FDA Action (Update2) - Bloomberg May 30 (Bloomberg) -- Two Americans died and 15 suffered seizures. The suspected cause: The epilepsy medicine they depended on stopped working because of a counterfeit ingredient from overseas. The case of the flawed drug, made by a company that no Source: www.bloomberg.com UPDATE 1-FDA panel says data backs use of Glaxo's Promacta - Reuters CHICAGO, May 30 (Reuters) - An expert advisory panel to the U.S. Food and Drug Administration said on Friday that current clinical data supports short-term use of GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research )(GSK.N: Quote , Profile Source: www.reuters.com State to share in Vioxx accord - Baltimore Sun Merck & Co. has agreed to pay $58 million to multiple states, including Maryland, to settle allegations that its ads for the once-popular painkiller Vioxx deceptively played down the health risks. The agreement announced yesterday also calls for Source: www.baltimoresun.com FDA: Time for asthma patients to switch inhalers - Salon May 30th, 2008 | WASHINGTON -- Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives Source: www.salon.com Lupin receives USFDA nod for Topiramate tablets - MyIris Lupin , leading drugmaker received tentative approval for its abbreviated new drug application (ANDA) for Topiramate tablets, 25 mg, 50mg, 100mg and 200 from the US Food and Drug Administration (US FDA). Lapin`s Topiramate tablets are the AB rated Source: www.myiris.com FDA panel favors Glaxo, Ligand blood drug - Los Angeles Times WASHINGTON -- Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: www.latimes.com Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes
Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi... Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Cardinal Alcohol-Free Mouthwash Additional lot recalled because of the presence of Burkholderia cepacia. Heparin Sodium Injection FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Recalls and Safety Alerts: Unsafe Use of Extended-Release Tussionex Suspension FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorp... Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and Relenza Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients... Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)
FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). Current Drug Shortage: Neupro (rotigotine transdermal system) UCB is preparing to recall all Neupro lots in the U.S. by May 2008 FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. FDA Requests Recall of Xiadafil VIP Tabs The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Cardinal Alcohol-Free Mouthwash Additional lot recalled because of the presence of Burkholderia cepacia. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. FDA urges patients to switch to new inhalers - Detroit Free Press FDA urges patients to switch to new inhalers - Detroit Free Press
WASHINGTON — Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year’s end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use Source: www.freep.com Loose lips can sink stocks - Baltimore Sun So much can depend on a subcutaneous micro-infusion device. Thats what Marylands United Therapeutics hopes will deliver its first product to patients. Its also the companys hope for delivery to the promised land of profitable biotech concerns Source: www.baltimoresun.com Wyeth:FDA Fast Track For Pediatric Pneumococcal Vaccine - CNN Money Wyeth's (WYE) division, Wyeth Pharmaceuticals, said the Food and Drug Administration granted fast track designation to its investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The company is seeking a pediatric Source: money.cnn.com FDA: Time for asthma patients to switch inhalers - Morris County Daily Record WASHINGTON (AP) -- Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end -- and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use Source: www.dailyrecord.com UPDATE: Glenmark Gets FDA OK For Generic Mometasone Furoate - CNN Money BANGALORE -(Dow Jones)- Glenmark Generics Ltd. - a unit of drugmaker Glenmark Pharmaceuticals Ltd. (532296.BY) - has received the U.S. Food and Drug Administration's approval to make and sell generic Mometasone Furoate ointment and cream. Mometasone Source: money.cnn.com FDA reminds asthma patients it's time to get new CFC-free inhalers - Minneapolis Star Tribune Yes, thanks to the FDA for renewing the patent on Albuterol, thus reducing the number of providers to three. That's the reason that … read more inhalers tend to be more expensive now - not because of the new "HFA" technology. Once again, thanks Source: www.startribune.com Eli Lilly asks FDA to expand approved Cymbalta use - CNN Money Eli Lilly asks FDA to expand approved Cymbalta use - CNN Money
NEW YORK (Associated Press) - Drug developer Eli Lilly and Co. said Thursday it asked the Food and Drug Administration to approve its depression drug Cymbalta as a chronic pain treatment. The company said its filing with the FDA is based on studies Source: money.cnn.com May 30, 2008Combating Antibiotic Resistance Combating Antibiotic Resistance
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and Relenza Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients... FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Recalls and Safety Alerts: Liver Injury with Tysabri Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f... Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. PROMACTA(R) (eltrombopag) RECEIVES UNANIMOUS RECOMMENDATION BY FDA - MSN MoneyCentral PROMACTA(R) (eltrombopag) RECEIVES UNANIMOUS RECOMMENDATION BY FDA - MSN MoneyCentral
Panel Votes, 16-0, in Favor of Short-Term Treatment of Chronic Idiopathic Thrombocytopenic Purpura (ITP) CHICAGO, May 30 /PRNewswire-USNewswire/ -- GlaxoSmithKline GSK today announced that the United States Food and Drug Administration's Oncology Source: news.moneycentral.msn.com FDA panel favors Glaxo, Ligand blood drug - Forbes Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside advisers voted Source: www.forbes.com UPDATE 2-FDA panel says data backs use of Glaxo's Promacta - Reuters CHICAGO, May 30 (Reuters) - An expert advisory panel to the U.S. Food and Drug Administration said on Friday that current clinical data supports short-term use of GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research )(GSK.N: Quote , Profile Source: www.reuters.com Wyeth gets fast track designation from FDA for investigational vaccine - Forbes NEW YORK (Thomson Financial) - Wyeth's pharmaceutical unit Thursday said it received fast track designation from the Food and Drug Administration for its investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The company Source: www.forbes.com Tainted Drug Imports Set Off Warnings, Not FDA Action (Update2) - Bloomberg May 30 (Bloomberg) -- Two Americans died and 15 suffered seizures. The suspected cause: The epilepsy medicine they depended on stopped working because of a counterfeit ingredient from overseas. The case of the flawed drug, made by a company that no Source: www.bloomberg.com FDA reminds asthma patients it's time to switch to CFC-free inhalers - Minneapolis Star Tribune thanks to the HFA switchover, I discovered Advair and have all but eliminated my need for a fast acting inhaler, leading to a much more … read more active and fulfilling life. the kicker is the Advair costs about as much as my HFA inhaler would Source: www.startribune.com FDA: Time for asthma patients to switch inhalers - FOX News WASHINGTON — Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end _ and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use Source: www.foxnews.com FDA: Time for asthma patients to get new inhalers - MSN MoneyCentral Sepracor Inc ( SEPR ) Stock Quote , Chart , News , Add to Watchlist WASHINGTON (AP) - Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year's end — and the government is urging patients not to wait until Source: moneycentral.msn.com FDA panel says data backs use of Glaxo's Promacta - Forbes CHICAGO (Reuters) - An expert advisory panel to the U.S. Food and Drug Administration said Friday that current clinical data supports short-term use of GlaxoSmithKline (nyse: GSK - news - people ) Plc's experimental platelet-boosting drug, Promacta Source: www.forbes.com Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16)
Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and Relenza Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients... Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. FDA Requests Recall of Xiadafil VIP Tabs The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi... Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ... Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)
FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). FDA Approves New Formulation of Coagulation Therapy he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. India's Glenmark gets U.S. FDA clearance to market skin disorder - Forbes India's Glenmark gets U.S. FDA clearance to market skin disorder - Forbes
MUMBAI (Thomson Financial) - India's Glenmark Pharmaceuticals Ltd. said its subsidiary Glenmark Generics Ltd. received U.S. FDA approval to market drugs that treat skin disorders and diabetes in the U.S. The approval covers Mometasone Furoate Source: www.forbes.com FDA Proposes Change To Physician Labeling - Post Chronicle The U.S. Food and Drug Administration said it is proposing major revisions to the physician labeling of prescription drugs. FDA officials said the proposed changes would provide better information about the effects of medicines used during pregnancy Source: www.postchronicle.com FDA reminds asthma patients it's time to switch to CFC-free inhalers - Minneapolis Star Tribune WASHINGTON - Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use inhalers Source: www.startribune.com U.S. Agency Supports New York Restaurant Calorie Rule (Update1) - Bloomberg May 30 (Bloomberg) -- The U.S. Food and Drug Administration said New York City has the power to require McDonald's Corp. , Burger King Holdings Inc. and other chain restaurants to post the calorie content of their food. The FDA supported a new city Source: www.bloomberg.com Tainted Drug Imports Set Off Warnings, Not FDA Action (Update1) - Bloomberg May 30 (Bloomberg) -- Two Americans died and 15 suffered seizures. The suspected cause: The epilepsy medicine they depended on stopped working because of a counterfeit ingredient from overseas. The case of the flawed drug, made by a company that no Source: www.bloomberg.com Mommy's Bliss Nipple Cream Mommy's Bliss Nipple Cream
Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Cardinal Alcohol-Free Mouthwash Product recalled because of the presence of Burkholderia cepacia. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. FDA Takes Action Against Scientific Laboratories Inc. A permanent injunction bars Scientific Laboratories from making and distributing drug products until its manufacturing operations comply with law and its products are approved. Xiadafil VIP Tablets Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Controlling Cholesterol with Statins When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Trasylol (aprotinin injection) Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. FDA may change how it labels which drugs are safe during pregnancy - Minneapolis Star Tribune FDA may change how it labels which drugs are safe during pregnancy - Minneapolis Star Tribune
WASHINGTON - Doctors may soon get a new way to tell which medications are safe for women to use during pregnancy and when they breastfeed. Today, prescription drugs carry a code in the fine print of their labels that rank their pregnancy safety Source: www.startribune.com FDA Proposes New Drug Labels for Pregnant Women - KVIA.com WEDNESDAY, May 28 (HealthDay News) -- U.S. health officials proposed Wednesday changes to the labels on prescription drugs that would detail potential health effects for pregnant and breast-feeding women, their fetuses or their newborns. If enacted Source: www.kvia.com Glaxo, Ligand drug gets negative FDA assessment - MSN MoneyCentral NEW YORK (AP) - A Food and Drug Advisory Committee said Wednesday GlaxoSmithKline's blood-clotting disorder drug Promacta is no more effective than placebo, sending shares of longtime partner Ligand Pharmaceuticals Inc. plunging to a new low. On Source: moneycentral.msn.com Glaxo's Promacta has little effect-US FDA staffer - Reuters WASHINGTON, May 28 (Reuters) - GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research ) (GSK.N: Quote , Profile , Research ) Promacta, an experimental platelet-boosting drug, did not help control bleeding any better than a placebo, a U.S. Food and Source: www.reuters.com Dr Reddy's gets tentative US FDA nod for omeprazole - Reuters Dr Reddy's gets tentative US FDA nod for omeprazole - Reuters
MUMBAI, May 30 (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd (REDY.BO: Quote , Profile , Research )(RDY.N: Quote , Profile , Research ) has received tentative approval from the U.S. Food and Drug Administration for omeprazole delayed Source: www.reuters.com FDA asks Xiadafil VIP Tabs be recalled - The Money Times Washington -- The U.S. Food and Drug Administration said it has asked SEI Pharmaceuticals of Miami to recall all of its Xiadafil VIP Tabs. The FDA said the recalled drug -- sold in 8 tablet bottles (Lot 6K029) or blister cards of 2 tablets (Lot 6K029 Source: www.themoneytimes.com RPT India's Lupin says gets tentative FDA approval for Topiramate - CNBC (Repeating to show approval was tentative in first paragraph) MUMBAI (Thomson Financial) - Indian pharmaceutical company Lupin Ltd. said it has received tentative approval from the U.S. Food and Drug Administration for the abbreviated new drug Source: www.cnbc.com Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
Dear Healthcare Professional Letter is available. Drug Approved for Irritable Bowel Syndrome with Constipation FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Bayer Removes Remaining Trasylol Stock Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. Enbrel (etanercept) Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis. Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). Controlling Cholesterol with Statins When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. May 29, 2008FDA Approves New Formulation of Coagulation Therapy FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Device Identifies Fatty Deposits in Coronary Arteries A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. Controlling Cholesterol with Statins When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. AMAG Pharmaceuticals, Inc. to Webcast Upcoming Analyst and Investor - MSN MoneyCentral AMAG Pharmaceuticals, Inc. to Webcast Upcoming Analyst and Investor - MSN MoneyCentral
AMAG Pharmaceuticals, Inc. AMAG today announced it will webcast its Analyst and Investor meeting taking place on June 6, 2008 in New York City beginning at 8:00 am ET. At the meeting, the Company intends to discuss the ferumoxytol development program Source: news.moneycentral.msn.com FDA's Chief of Staff, Susan Winckler and Peter Thonis, Chief - Phramalive.com http://www.exlpharma.com ) is pleased to announce the participation of two keynote speakers from the U.S. Food and Drug Administration and Verizon during the 4th Annual Public Relations and Communications Summit: The Leading Event for Pharmaceutical Source: www.pharmalive.com FDA proposes change to physician labeling - United Press International WASHINGTON, May 29 (UPI) -- The U.S. Food and Drug Administration said it is proposing major revisions to the physician labeling of prescription drugs. FDA officials said the proposed changes would provide better information about the effects of Source: www.upi.com Wyeth Receives Approvable Letter from FDA for TYGACIL for the - Phramalive.com COLLEGEVILLE, Pa., May 29, 2008 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL(R Source: www.pharmalive.com FDA asks Xiadafil VIP Tabs be recalled - The Money Times Washington -- The U.S. Food and Drug Administration said it has asked SEI Pharmaceuticals of Miami to recall all of its Xiadafil VIP Tabs. The FDA said the recalled drug -- sold in 8 tablet bottles (Lot 6K029) or blister cards of 2 tablets (Lot 6K029 Source: www.themoneytimes.com FDA Approvals: Entereg and Aranesp CME - Medscape News Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s) ™ for physicians; Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians To participate in this internet activity: (1) review the target audience, learning objectives, and Source: www.medscape.com FDA Proposes New Drug Labels for Pregnant Women - WTVF FDA Proposes New Drug Labels for Pregnant Women - WTVF
WEDNESDAY, May 28 (HealthDay News) -- U.S. health officials proposed Wednesday changes to the labels on prescription drugs that would detail potential health effects for pregnant and breast-feeding women, their fetuses or their newborns. If enacted Source: www.newschannel5.com FDA requests more info on Wyeth's pneumonia drug - Boston Globe COLLEGEVILLE, Pa.— Wyeth said Thursday the Food and Drug Administration will require more information on the safety and effectiveness of its antibiotic Tygacil in treating community-acquired pneumonia before granting approval. Tygacil is currently Source: www.boston.com GS1 US and FMI to Unveil Powerful New Tool to Address Recall - Forbes Recent product recalls worldwide have forced businesses to re-assess their current recall operating procedures and to look for new ways to improve existing recall efforts to ensure consumer safety. In response, GS1 US and the Food Marketing Institute Source: www.forbes.com UPDATE 1-Lilly sees approval soon for long-acting Zyprexa - Reuters NEW YORK, May 29 (Reuters) - Eli Lilly and Co (LLY.N: Quote , Profile , Research ) said on Thursday a long-acting form of its schizophrenia drug Zyprexa will likely become available in the United States in the "near future," based on favorable Source: www.reuters.com Lilly sees approval soon for long-acting Zyprexa - Reuters NEW YORK, May 29 (Reuters) - Eli Lilly and Co (LLY.N: Quote , Profile , Research ) said on Thursday the long-acting form of its schizophrenia drug Zyprexa will likely become available in the United States in the "near future," based on favorable Source: www.reuters.com Watson says Oxybutynin Topical Gel NDA accepted for filing by FDA - Forbes CORONA, Calif. (Thomson Financial) - Watson Pharmaceuticals , Inc., a specialty pharmaceutical company, announced Wednesday that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food Source: www.forbes.com FDA says Glaxo drug fails to control bleeding - Associated Press WASHINGTON (AP) -- An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to Source: hosted.ap.org Wyeth gets fast track designation from FDA for investigational vaccine - Forbes NEW YORK (Thomson Financial) - Wyeth's pharmaceutical unit Thursday said it received fast track designation from the Food and Drug Administration for its investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The company Source: www.forbes.com FDA requests more info on Wyeth's pneumonia drug - Forbes Wyeth said Thursday the Food and Drug Administration will require more information on the safety and effectiveness of its antibiotic Tygacil in treating community-acquired pneumonia before granting approval. Tygacil is currently approved to treat Source: www.forbes.com Cardinal Alcohol-Free MouthwashEli Lilly submits supplemental new drug application for Cymbalta - CNBC Eli Lilly submits supplemental new drug application for Cymbalta - CNBC
NEW YORK (Thomson Financial) - Eli Lilly and Co. Thursday said it submitted a supplemental new drug application to the Food and Drug Administration for a new version of its drug Cymbalta, which treats depressive disorder and diabetic peripheral Source: www.cnbc.com New Drug Eases Severe Constipation - NewsMax.com An experimental once-a-day pill offered relief to nearly half the people with severe, long-term constipation, researchers reported on Wednesday. The drug prucalopride, which Belgium-based Movetis NV plans to market in Europe under the brand name Source: www.newsmax.com Eli Lilly asks FDA to expand approved Cymbalta use - Forbes Drug developer Eli Lilly and Co. said Thursday it asked the Food and Drug Administration to approve its depression drug Cymbalta as a chronic pain treatment. The company said its filing with the FDA is based on studies conducted in patients with Source: www.forbes.com Ligand shares fall 34% on FDA report - San Diego Union-Tribune Shares of Ligand Pharmaceuticals plunged 34 percent after federal drug regulators released documents that indicate they do not favor approving the company's experimental blood disorder drug, Promacta. The Food and Drug Administration in effect called Source: www.signonsandiego.com Wyeth:FDA Fast Track For Pediatric Pneumococcal Vaccine - CNN Money Wyeth's (WYE) division, Wyeth Pharmaceuticals, said the Food and Drug Administration granted fast track designation to its investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The company is seeking a pediatric Source: money.cnn.com UPDATE 1-Glaxo seeks U.S. approval for anti-nausea drug - Reuters LONDON, May 29 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote , Profile , Research ) said on Thursday it had submitted its new anti-nausea drug Rezonic for approval in the United States, and presented fresh clinical data supporting the medicine's Source: www.reuters.com Glaxo seeks FDA approval for anti-vomiting drug - Forbes GlaxoSmithKline PLC said Thursday it submitted an application to the Food and Drug Administration to approve a drug to treat nausea and vomiting associated with chemotherapy. The U.K.-based drug maker said its application is supported by two late Source: www.forbes.com Lilly Submits Cymbalta(R) Supplemental New Drug Application for - MSN MoneyCentral Eli Lilly and Company (NYSE: LLY) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for Cymbalta® (duloxetine HCl) for the management of chronic pain, the Source: news.moneycentral.msn.com Discovery Laboratories receives notice of meeting with FDA regarding - CNBC Discovery Laboratories receives notice of meeting with FDA regarding - CNBC
NEW YORK (Thomson Financial) - Discovery Laboratories Inc. Thursday said it received notice of a meeting with the Food and Drug Administration to confirm the company's approach to addressing items necessary to gain U.S. marketing approval of its drug Source: www.cnbc.com Pfizer Starts Media Ad Blitz to Address Smoking Drug Concerns - Bloomberg May 29 (Bloomberg) -- Pfizer Inc. , the world's biggest drugmaker, will run newspaper ads and send letters to doctors to quell concerns about its quit-smoking treatment Chantix, linked to suicides, seizures, and traffic accidents. The New York-based Source: www.bloomberg.com FDA reviewing Pfizer smoking-cessation drug - Reuters WASHINGTON (Reuters) - The Food and Drug Administration is taking a closer look at Pfizer Inc's (PFE.N: Quote , Profile , Research ) anti-smoking drug Chantix after reports of patients experiencing hundreds of serious problems, an agency official Source: www.reuters.com FDA takes another look at prescription warnings - Baltimore Sun WASHINGTON - Federal health officials proposed yesterday streamlining prescription drug warnings for women who are pregnant or nursing, to make it easier for physicians and patients to determine whether it's safe to take the medicines. The Food and Source: www.baltimoresun.com Drug Labeling Aimed at Pregnant Women May Change - FOX News Doctors may soon get a new way to tell which medications are safe for women to use during pregnancy and when they breastfeed. Today, prescription drugs carry a code in the fine print of their labels that rank their pregnancy safety: Category A means Source: www.foxnews.com Figure Skater Peggy Fleming Teams With HealthSaver: The Impact of Diet - Forbes NORWALK, Conn., May 29 /PRNewswire/ -- Complementary and alternative medicine is a diverse group of health care practices not presently considered to be a part of traditional medicine. According to the U.S. Department of Health and Human Services Source: www.forbes.com FDA says Glaxo drug fails to control bleeding - San Francisco Gate An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to treat a disorder that Source: www.sfgate.com HGS to Test Lupus Drug As an MS Treatment - Washington Post Human Genome Sciences told analysts yesterday that it was moving forward on several biotechnology drugs and that it planned to begin testing its experimental lupus drug as a treatment for multiple sclerosis. "One of the knocks on this company is that Source: www.washingtonpost.com Figure Skater Peggy Fleming Teams With HealthSaver: The Impact of Diet - Forbes Figure Skater Peggy Fleming Teams With HealthSaver: The Impact of Diet - Forbes
NORWALK, Conn., May 29 /PRNewswire/ -- Complementary and alternative medicine is a diverse group of health care practices not presently considered to be a part of traditional medicine. According to the U.S. Department of Health and Human Services Source: www.forbes.com FDA reviewing Pfizer smoking-cessation drug - Reuters WASHINGTON (Reuters) - The Food and Drug Administration is taking a closer look at Pfizer Inc's (PFE.N: Quote , Profile , Research ) anti-smoking drug Chantix after reports of patients experiencing hundreds of serious problems, an agency official Source: www.reuters.com U.S. reviewing Pfizer smoking-cessation drug - Guardian Unlimited WASHINGTON, May 27 (Reuters) - The U.S. Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of patients experiencing hundreds of serious problems, an agency official told Reuters on Tuesday Source: www.guardian.co.uk Pfizer Starts Media Ad Blitz to Address Smoking Drug Concerns - Bloomberg May 29 (Bloomberg) -- Pfizer Inc. , the world's biggest drugmaker, will run newspaper ads and send letters to doctors to quell concerns about its quit-smoking treatment Chantix, linked to suicides, seizures, and traffic accidents. The New York-based Source: www.bloomberg.com UPDATE 1-U.S. reviewing Pfizer smoking-cessation drug - Guardian Unlimited SILVER SPRING, Md., May 27 (Reuters) - The U.S. Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of hundreds of patients experiencing serious problems, an agency official told Reuters on Source: www.guardian.co.uk Drug Labeling Aimed at Pregnant Women May Change - FOX News Doctors may soon get a new way to tell which medications are safe for women to use during pregnancy and when they breastfeed. Today, prescription drugs carry a code in the fine print of their labels that rank their pregnancy safety: Category A means Source: www.foxnews.com FDA says Glaxo drug fails to control bleeding - Los Angeles Times WASHINGTON -- An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to treat a Source: www.latimes.com ZymoGenetics gets OK for blood-clotting drug size - Forbes ZymoGenetics Inc. said Tuesday the Food and Drug Administration approved a larger vial size for the biotechnology company's blood-clotting drug Recothrom Thrombin. The drug was already available in 5,000 IU vials and is approved in 20,000 IU vials Source: www.forbes.com FDA takes another look at prescription warnings - Baltimore Sun WASHINGTON - Federal health officials proposed yesterday streamlining prescription drug warnings for women who are pregnant or nursing, to make it easier for physicians and patients to determine whether it's safe to take the medicines. The Food and Source: www.baltimoresun.com FDA reviewing Pfizer anti-smoking drug - Reuters SILVER SPRING, Maryland (Reuters) - The Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of hundreds of patients experiencing serious problems, an agency official told Reuters on Tuesday Source: www.reuters.com Put Animal Testing to Sleep - BusinessWeek Put Animal Testing to Sleep - BusinessWeek
What if you tried to start your car and realized you had the wrong key? Would you keep trying to make it fit the ignition, or would you find the right key? It seems a silly question, but this is the situation for researchers who use animals to study Source: www.businessweek.com UPDATE 1-U.S. reviewing Pfizer smoking-cessation drug - Guardian Unlimited SILVER SPRING, Md., May 27 (Reuters) - The U.S. Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of hundreds of patients experiencing serious problems, an agency official told Reuters on Source: www.guardian.co.uk FDA reviewing Pfizer smoking-cessation drug - Reuters WASHINGTON (Reuters) - The Food and Drug Administration is taking a closer look at Pfizer Inc's (PFE.N: Quote , Profile , Research ) anti-smoking drug Chantix after reports of patients experiencing hundreds of serious problems, an agency official Source: www.reuters.com ZymoGenetics gets OK for blood-clotting drug size - Forbes ZymoGenetics Inc. said Tuesday the Food and Drug Administration approved a larger vial size for the biotechnology company's blood-clotting drug Recothrom Thrombin. The drug was already available in 5,000 IU vials and is approved in 20,000 IU vials Source: www.forbes.com U.S. reviewing Pfizer smoking-cessation drug - Guardian Unlimited WASHINGTON, May 27 (Reuters) - The U.S. Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of patients experiencing hundreds of serious problems, an agency official told Reuters on Tuesday Source: www.guardian.co.uk FDA says Glaxo drug fails to control bleeding - Los Angeles Times WASHINGTON -- An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to treat a Source: www.latimes.com FDA reviewing Pfizer anti-smoking drug - Reuters SILVER SPRING, Maryland (Reuters) - The Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of hundreds of patients experiencing serious problems, an agency official told Reuters on Tuesday Source: www.reuters.com FDA Approves Amitiza for IBS-C FDA Approves Amitiza for IBS-C
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx� Stent Graft System In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx� Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ... FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ... A Guide to Drug Safety Terms at FDA This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug. May 28, 2008FDA says Glaxo drug fails to control bleeding - Los Angeles Times FDA says Glaxo drug fails to control bleeding - Los Angeles Times
WASHINGTON -- An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to treat a Source: www.latimes.com FDA asks Xiadafil VIP Tabs be recalled - The Money Times Washington -- The U.S. Food and Drug Administration said it has asked SEI Pharmaceuticals of Miami to recall all of its Xiadafil VIP Tabs. The FDA said the recalled drug -- sold in 8 tablet bottles (Lot 6K029) or blister cards of 2 tablets (Lot 6K029 Source: www.themoneytimes.com Glaxo, Ligand drug gets negative FDA assessment - CNN Money NEW YORK (Associated Press) - A Food and Drug Advisory Committee said Wednesday GlaxoSmithKline's blood-clotting disorder drug Promacta is no more effective than placebo, sending shares of longtime partner Ligand Pharmaceuticals Inc. plunging to a Source: money.cnn.com Watson says Oxybutynin Topical Gel NDA accepted for filing by FDA - Forbes CORONA, Calif. (Thomson Financial) - Watson Pharmaceuticals , Inc., a specialty pharmaceutical company, announced Wednesday that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food Source: www.forbes.com Pfizer Seeks to Counter Chantix Concerns - Wall Street Journal WASHINGTON -- Pfizer Inc. is preparing an advertising and public-relations campaign to counter concerns about its antismoking drug Chantix, once trumpeted as a potential billion-dollar-a-year blockbuster. Chantix is drawing scrutiny from federal Source: online.wsj.com Labs accused of helping food importers beat FDA - Chicago Tribune WASHINGTON—A congressional committee is investigating whether some private U.S. laboratories were instructed to withhold samples of tainted food so that importers could get their goods into the U.S. In a May 1 letter to 10 labs, the House Committee Source: www.chicagotribune.com FDA Orders ED Supplement Recall - WebMD May 27, 2008 -- Due to a risky ingredient, the FDA has ordered a recall of certain lots of Xiadafil VIP Tabs, an illegally marketed "all-natural" dietary supplement touted for sexual enhancement and erectile dysfunction (ED) treatment. FDA lab tests Source: www.webmd.com FDA official sees some delays over safety - Reuters UK SILVER SPRING, Maryland (Reuters) - A new focus on drug safety is delaying the approval of some medicines as regulators impose requirements meant to minimize side effects, a top U.S. drug regulator told Reuters on Tuesday. The Food and Drug Source: uk.reuters.com Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23) WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Recalls and Safety Alerts: Unsafe Use of Extended-Release Tussionex Suspension FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorp... Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. New Type of Latex Glove Cleared New Type of Latex Glove Cleared
FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. A Guide to Drug Safety Terms at FDA This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) |
