September 13, 2008Rituxan (rituximab) Rituxan (rituximab)
Progressive Multifocal Leukoencephalopathy with use of Rituxan in patient with rheumatoid arthritis. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007) This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the publication "Safe Practices in Pa... Pacific Consolidated brand Mobile Oxygen Storage Tank Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. Recalls and Safety Alerts: Preventing Meningitis in Children with Cochlear Implants (December 2007) This story originally aired in December 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is reminding healthcare practitioners about the importan... Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008) This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join... Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008) This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des... Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007) This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent report from the Institute for Safe Medication Prac... FDA approves vaginal cancer vaccine - Presstv FDA approves vaginal cancer vaccine - Presstv
FDA officials have approved the Gardasil vaccine which will prevent from vulvar and vaginal cancers in girls and women aged 9 to 26. Gardasil first gained FDA approval in 2006 for cervical cancer, and abnormal precancerous genital lesions and warts Source: www.presstv.ir Avoid Chinese Infant Formula, FDA Warns - Eflux Media The FDA issued a warning saying that parents and caregivers should avoid feeding babies with infant formula made in China, on account of potential contamination with melamine, the chemical substance found in pet food from China and associated with Source: www.efluxmedia.com Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008) Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008)
This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join... Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007) This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent report from the Institute for Safe Medication Prac... Preventing Medical Errors: What to Do about Unretrieved Device Fragments (January 2008) This story originally aired in January 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the journal Nursing2007 alerts health... FDA to Post Quarterly Report of Potential Safety Issues The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Potential Problems at Two Baltimore Pharmacies Potential Problems at Two Baltimore Pharmacies
FDA is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5) Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29) Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 because it has the potential to be contaminated with Listeria monocytogenes, an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Avoid Chinese-made baby formula: FDA - Reuters Avoid Chinese-made baby formula: FDA - Reuters
WASHINGTON (Reuters) - Baby formula from China is illegal in the United States and should not be used, U.S. regulators warned on Thursday after Chinese officials blamed tainted formula for the death of an infant. U.S. Food and Drug Administration Source: www.reuters.com FDA issues warning about baby formula produced in China - Arizona Daily Star BEIJING — Investigators believe dairy farmers added a dangerous chemical to milk that has been linked to kidney stones in dozens of babies and one death in China's latest product-safety scandal. The government vowed "serious punishment" on Friday Source: www.azstarnet.com FDA hires 1,300 new doctors and scientists - NWITimes.com WASHINGTON - The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific Source: nwitimes.com FDA hires more than 1,300 health professionals - MSNBC WASHINGTON - The Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that officials hope will help it better protect the public health amid rapid technological and scientific change. "Every pay period, we Source: www.msnbc.msn.com FDA cites brain virus with Genentech, Biogen drug - Boston Globe WASHINGTON— Federal regulators said Thursday one case of a deadly brain infection has been reported in a patient taking Genentech and Biogen Idec's blockbuster arthritis and cancer drug Rituxan. The Food and Drug Administration said the woman died Source: www.boston.com FDA warns baby formula could be contaminated - Pensacola News Journal The Food and Drug Administration is alerting Asian and ethnic markets throughout the United States that infant formula made in China may be contaminated. The FDA is working with state health agencies across the country to make members of Chinese Source: www.pnj.com FDA: Infant Formula From China Tainted - Washington Post WASHINGTON -- Federal officials warned Thursday that tainted infant formula from China may be on sale at ethnic groceries in this country, even though it is not legally approved for importation. The Food and Drug Administration urged U.S. consumers Source: www.washingtonpost.com September 12, 2008A New Wrinkle for an Old Drug - Motley Fool A New Wrinkle for an Old Drug - Motley Fool
Apparently, sometimes you can teach an old drug new tricks. On Thursday, Allergan (NYSE: AGN ) announced that its drug Botox succeeded in two pivotal studies testing its ability to prevent migraine headaches. The stock ended the day up more than 10 Source: www.fool.com Investors await crucial bone drug data from Amgen - Guardian Unlimited BOSTON, Sept 12 (Reuters) - Results due next week from a trial of Amgen Inc's experimental osteoporosis drug denosumab will represent a pivotal moment for the world's biggest biotechnology company as it struggles with declining sales of its flagship Source: www.guardian.co.uk Surprise checks on drug trials soon - Business Standard The hospitals, the sponsor pharma companies and the institutional ethics committees that oversee these trials will all come under the regulator’s scanner. “The inspections have been planned to create confidence among various stakeholders on Source: www.business-standard.com FDA Hires 1,300 in Public Health Effort - FOX News WASHINGTON — The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific Source: www.foxnews.com FDA tells parents to avoid infant formula from China - Seattle Times WASHINGTON — Tainted infant formula from China may be on sale at ethnic groceries in this country, even though it is not approved for importation, federal officials warned Thursday. The Food and Drug Administration (FDA) officials stressed that the Source: seattletimes.nwsource.com China recalls toxic baby food - Hindustan Times China has launched a nationwide probe into all domestic baby milk powder products, after samples of a major brand were found laced with a dangerous industrial chemical. Overnight, over 8000 tonnes of the Sanlu Group’s baby milk powder has been Source: www.hindustantimes.com Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008) Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008)
This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des... Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers. Byetta (exenatide) UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta. Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008) Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008)
This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des... Warning on Certain Mussel Products from Bantry Bay Seafood FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins. FDA cites brain virus with Genentech, Biogen drug - Boston Globe FDA cites brain virus with Genentech, Biogen drug - Boston Globe
WASHINGTON— Federal regulators said Thursday one case of a deadly brain infection has been reported in a patient taking Genentech and Biogen Idec's blockbuster arthritis and cancer drug Rituxan. The Food and Drug Administration said the woman died Source: www.boston.com FDA hires 1,300 new doctors and scientists - Atlanta Journal Constitution The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific change. “Every Source: www.ajc.com Avoid Chinese-made baby formula, FDA says - Reuters WASHINGTON (Reuters) - Baby formula from China is illegal in the United States and should not be used, U.S. regulators warned on Thursday after Chinese officials blamed tainted formula for the death of an infant. U.S. Food and Drug Administration Source: www.reuters.com FDA: Infant formula from China tainted by chemical - Miami Herald Tainted infant formula from China may be on sale at ethnic groceries in this country, even though it is not approved for importation, federal officials warned on Thursday. However, the Food and Drug Administration stressed that the domestic supply of Source: www.miamiherald.com FDA Hires 1,300 in Public Health Effort - FOX News WASHINGTON — The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific Source: www.foxnews.com India Sun Pharma gets U.S. FDA nod for alendronate - Reuters BANGALORE, Sept 12 (Reuters) - India's Sun Pharmaceutical Industries (SUN.BO: Quote , Profile , Research , Stock Buzz ) said it has received approval from the U.S. Food and Drug Administration to market alendronate sodium tablets, the generic version Source: www.reuters.com FDA Hires 1,300 Docs, Scientists - Time (WASHINGTON) — The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific Source: www.time.com Can Chantix Make A Comeback? - Forbes Pfizer will restart TV advertising for its Chantix anti-smoking drug on Sunday, nine months after voluntarily putting the campaign on hold as worries about a link between the medicine and suicidal thoughts and actions grew. The spots run 90 seconds Source: www.forbes.com FDA beefs up workforce with 1,300 new staffers - San Francisco Gate The Food and Drug Administration said Thursday that it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect public health amid rapid technological and scientific change. "Every Source: www.sfgate.com FDA: Tainted Infant Formula That Sickened 59 Babies in China May Be on - FOX News However, the Food and Drug Administration stressed that the domestic supply of infant formula is safe. FDA officials are urging U.S. consumers to avoid all infant formula from China, after several brands sold in that country came under suspicion of Source: www.foxnews.com 1 Drug Beats Another, but Who Will Care? - The Money Times 1 Drug Beats Another, but Who Will Care? - The Money Times
Yeah, this needle-phobic Fool would pick the pill, too. Amylin Pharmaceuticals (Nasdaq: AMLN) and Eli Lilly (NYSE: LLY) are fighting an uphill battle as they try to convince diabetics that the benefit from the two-needle-prick regimen of Byetta is Source: www.themoneytimes.com Alpharma reports positive Embeda pain drug data - Guardian Unlimited BOSTON, Sept. 9 (Reuters) - Alpharma Inc, which is fighting off a $1.4 billion takeover bid from King Pharmaceuticals Inc said on Tuesday that its experimental pain drug Embeda significantly reduced pain due to osteoarthritis of the hip or knee. Data Source: www.guardian.co.uk (Recasts, adds details) - Reuters Sept 11 (Reuters) - Jazz Pharmaceuticals Inc (JAZZ.O: Quote , Profile , Research , Stock Buzz ) said the final patient had completed participation in the first late-stage trial of JZP-6 for the treatment of chronic pain syndrome, fibromyalgia, and it Source: www.reuters.com Inspire Announces Plans for Clinical Testing of New Compound INS117548 - MSN MoneyCentral Inspire Pharmaceuticals, Inc. ISPH announced today that the standard 30-day review period by the U.S. Food and Drug Administration (FDA) relating to Inspire ’ s Investigational New Drug Application (IND) for INS117548 Ophthalmic Solution for the Source: news.moneycentral.msn.com Vanda shares rise on plans for FDA response - Forbes Shares of Vanda Pharmaceuticals Inc. ticked higher Thursday after the company said it plans to send the Food and Drug Administration a response to the rejection of its experimental schizophrenia drug iloperidone. The stock gained 3 cents, or 2.9 Source: www.forbes.com ImClone's Erbitux Extends Head, Neck Cancer Survival (Update1) - Bloomberg Sept. 11 (Bloomberg) -- ImClone Systems Inc .'s Erbitux prolongs survival for patients with recurring head and neck cancer more than chemotherapy alone, a ``notable'' potential treatment improvement, according to a report in the New England Journal Source: www.bloomberg.com Cell Genesys: FDA places partial clinical hold on GVAX Phase 3 program - Forbes BOSTON (Thomson Financial) - Cell Genesys Inc. Thursday said the Food and Drug Administration has placed a partial clinical hold on the GVAX Phase 3 program for prostate cancer as a result of the company's announcement to terminate the VITAL-2 Phase Source: www.forbes.com FDA Law Enforcers Protect Consumers' Health FDA Law Enforcers Protect Consumers' Health
Inside the FDA's Office of Criminial Investigations Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. Disposable Battery Operated Lavage System (BOLS) The cutting of battery pack cables for disposal can lead to sparks, fires, toxic fumes, and explosions. 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. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. September 11, 2008FDA Classifies as a Class I Action an Urgent Medical Device Correction - MSN MoneyCentral FDA Classifies as a Class I Action an Urgent Medical Device Correction - MSN MoneyCentral
Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc. MDT announced today the FDA has classified as a Class I action the company ’ s recently initiated and completed voluntary urgent medical device recall of 249 fully automatic LIFEPAK Source: news.moneycentral.msn.com Oxygen Biotherapeutics, Inc. Sets FDA Meeting Date for Proposed Phase - MSN MoneyCentral “ At that meeting, we will be extensively prepared to resolve any remaining issues and concerns the FDA may have, ” said company chairman and CEO Chris J. Stern, DBA. “ We view this as a positive development, as the agency has also offered to Source: news.moneycentral.msn.com Avoid Chinese-made baby formula: FDA - Reuters WASHINGTON (Reuters) - Baby formula from China is illegal in the United States and should not be used, U.S. regulators warned on Thursday after Chinese officials blamed tainted formula for the death of an infant. U.S. Food and Drug Administration Source: www.reuters.com FDA hires more than 1,300 health professionals - MSNBC WASHINGTON - The Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that officials hope will help it better protect the public health amid rapid technological and scientific change. "Every pay period, we Source: www.msnbc.msn.com Cardica surges following FDA approval for bypass surgery system - Forbes BOSTON (Thomson Financial) - Shares of Cardica Inc. soared Tuesday after the Redwood City, Calif.-based surgical systems maker said it received 510(k) clearance from the Food and Drug Administration to market its PAS-Port Proximal Anastomosis System Source: www.forbes.com FDA: Infant formula from China tainted by chemical - Miami Herald Tainted infant formula from China may be on sale at ethnic groceries in this country, even though it is not approved for importation, federal officials warned on Thursday. However, the Food and Drug Administration stressed that the domestic supply of Source: www.miamiherald.com Business Highlights - MSN MoneyCentral NEW YORK (AP) — Lehman Brothers has approached other major financial institutions about a potential acquisition or investment in the battered securities firm, people close to the situation said Thursday. The nation's No. 4 investment bank has been Source: moneycentral.msn.com China investigating milk powder in babies' illnesses - International Herald Tribune BEIJING : The Chinese safety watchdog is investigating a domestic milk powder brand to determine if the formula may have caused kidney stone cases in infants in at least seven provinces, Xinhua News Agency said Thursday. The General Administration of Source: www.iht.com FDA cites brain virus with Genentech, Biogen drug - Boston Globe WASHINGTON— Federal regulators said Thursday one case of a deadly brain infection has been reported in a patient taking Genentech and Biogen Idec's blockbuster arthritis and cancer drug Rituxan. The Food and Drug Administration said the woman died Source: www.boston.com FDA hires 1,300 new doctors and scientists - WJLA The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific change. "Every Source: www.wjla.com Voluntary Recall: Wegmans In-Store Made Bagels (September 10) Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard. Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer. Starway Inc. Issues Alert on Undeclared Sulfites in Ego Brand Preserved Peaches (September 3) EGO brand Preserved Peaches is sold in a 14 ounce, un-coded, clear plastic package and was distributed nationwide. It is a product of Malaysia. Recall of Patak's Dopiaza Cooking Sauce (September 4) ACH Food Companies, Inc. is recalling its Patak's Dopiaza Cooking Sauce sold in the United States because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products. The product is distributed nationally through retail stores. ACH Food Companies is notifying its distributors and stores that carry this product that it contains an undeclared milk allergen and to immediately remove it from distribution. Tysabri (natalizumab) Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year. LifePak CR Plus Automated External Defibrillators Class I Recall because the shock button is not visible, making the responder unable to provide shock therapy. FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. Voluntary Recall: Wegmans In-Store Made Bagels (September 10) Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard. Starway Inc. Issues Alert on Undeclared Sulfites in Ego Brand Preserved Peaches (September 3) EGO brand Preserved Peaches is sold in a 14 ounce, un-coded, clear plastic package and was distributed nationwide. It is a product of Malaysia. Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29) Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 because it has the potential to be contaminated with Listeria monocytogenes, an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5) Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts. Warning on Certain Mussel Products from Bantry Bay Seafood Warning on Certain Mussel Products from Bantry Bay Seafood
FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. 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. Tysabri (natalizumab) Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year. Cell Genesys: FDA places partial clinical hold on GVAX Phase 3 program - Forbes Cell Genesys: FDA places partial clinical hold on GVAX Phase 3 program - Forbes
BOSTON (Thomson Financial) - Cell Genesys Inc. Thursday said the Food and Drug Administration has placed a partial clinical hold on the GVAX Phase 3 program for prostate cancer as a result of the company's announcement to terminate the VITAL-2 Phase Source: www.forbes.com A Pfizer Drug With a Cloudy Future - The Money Times A cautious recommendation for approval is better than nothing. But don't bet the farm on it. On Monday, Pfizer (NYSE: PFE) and partner Ligand Pharmaceuticals (Nasdaq: LGND) received a positive vote from an FDA advisory panel committee for their Source: www.themoneytimes.com Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
See Web site for additional information on this current drug shortage Europe Drugmakers' Outlook Worsens on Patent Expirations - Bloomberg Europe Drugmakers' Outlook Worsens on Patent Expirations - Bloomberg
Sept. 11 (Bloomberg) -- The outlook for Europe's pharmaceutical industry worsened for a second year as companies face more patent expirations and increased generic-drug competition, Moody's Investors Service said. Moody's gave the industry outlook a Source: www.bloomberg.com First Treatment Sanctioned for Chorea in Huntington's Patients - Atlanta Journal Constitution FRIDAY, Aug. 15 (HealthDay News) -- Xenazine (tetrabenazine) has been approved by the U.S. Food and Drug Administration as the first drug to treat chorea, the jerky involuntary movement that occurs in people with Huntington's disease. It's the first Source: www.ajc.com UPDATE 2-Alpharma reports positive Embeda pain drug data - Reuters BOSTON, Sept. 9 (Reuters) - Alpharma Inc (ALO.N: Quote , Profile , Research , Stock Buzz ), which is fighting off a $1.4 billion takeover bid from King Pharmaceuticals Inc (KG.N: Quote , Profile , Research , Stock Buzz ) said on Tuesday that its Source: www.reuters.com September 10, 2008Novartis Kidney Cancer Treatment Is Granted Priority FDA Review - Wall Street Journal Novartis Kidney Cancer Treatment Is Granted Priority FDA Review - Wall Street Journal
ZURICH -- Novartis AG said Tuesday its experimental drug Afinitor has been granted priority review by the U.S. Food and Drug Administration for approval as treatment for advanced kidney cancer, paving the way for possible approval early next year Source: online.wsj.com Voluntary Recall: Wegmans In-Store Made Bagels (September 10) Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard. Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers. Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28) Landshire, Inc. is recalling its American Sub sandwich because it has the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5) Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts. Vivitrol (naltrexone) Serious injection site reactions may occur with the use of injectable naltrexone. July 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Clears Test to Help Doctors Manage Heart Transplant Patients The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection. Lucky Country Inc. Recalls All Natural Black Licorice Products (September 5) Lucky Country Inc. of Lincolnton, NC is recalling all of its natural black licorice products from California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Minnesota, New Hampshire, Pennsylvania, Utah, Virginia, and Washington State due to elevated levels of lead. Novartis Kidney Cancer Treatment Is Granted Priority FDA Review - Wall Street Journal Novartis Kidney Cancer Treatment Is Granted Priority FDA Review - Wall Street Journal
ZURICH -- Novartis AG said Tuesday its experimental drug Afinitor has been granted priority review by the U.S. Food and Drug Administration for approval as treatment for advanced kidney cancer, paving the way for possible approval early next year Source: online.wsj.com US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited
ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug Source: www.guardian.co.uk Cardica gets FDA nod for bypass surgery device - Forbes - Sept 9 (Reuters) - Cardica Inc said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent before the bell. The medical device maker said Source: www.forbes.com VioQuest Pharmaceuticals Receives 510(k) Response from FDA for Xyfid - MSN MoneyCentral VioQuest Pharmaceuticals VOQP today announced that it has received a determination from the U.S. Food and Drug Administration (FDA) that Xyfid ™ (1% uracil topical) is a drug rather than a device and would be regulated with the Center for Drug Source: news.moneycentral.msn.com US FDA panel mixed on Pfizer bone drug risks - Forbes ROCKVILLE, Md. (Reuters) - Members of a U.S. advisory panel said Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said they Source: www.forbes.com Pfizer Close To FDA Approval For Osteoporisis Drug - E Canada Now Washington (ECN) - Pfizer is closer than ever to receiving FDA approval for its osteoporosis drug Fablyn. A panel of medical experts has coem out and stated that the Pfizer osteoporosis drug has more benefits for postmenopausal woman than it does Source: www.ecanadanow.com FDA panel mixed on Pfizer bone drug risks - Reuters ROCKVILLE, Maryland (Reuters) - Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said Source: www.reuters.com DOR BioPharma Announces Named Patient Access Program for Latin America - MSN MoneyCentral DOR BioPharma Announces Named Patient Access Program for Latin America - MSN MoneyCentral
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain Source: news.moneycentral.msn.com Pfizer Close To FDA Approval For Osteoporisis Drug - E Canada Now Washington (ECN) - Pfizer is closer than ever to receiving FDA approval for its osteoporosis drug Fablyn. A panel of medical experts has coem out and stated that the Pfizer osteoporosis drug has more benefits for postmenopausal woman than it does Source: www.ecanadanow.com Cardica gets FDA approval for surgical system - Forbes Surgical systems maker Cardica Inc. said Tuesday the Food and Drug Administration approved its PAS-Port system for use in cardiac bypass surgery. The system creates a secure connection between the body's main artery and vein grafts. Cardiac bypass Source: www.forbes.com VioQuest Pharmaceuticals Receives 510(k) Response from FDA for Xyfid - MSN MoneyCentral VioQuest Pharmaceuticals VOQP today announced that it has received a determination from the U.S. Food and Drug Administration (FDA) that Xyfid ™ (1% uracil topical) is a drug rather than a device and would be regulated with the Center for Drug Source: news.moneycentral.msn.com Proteon Receives FDA Fast Track Designation for First Drug Candidate - Genetic Engineering News Proteon Therapeutics, Inc., announced today it has received Food and Drug Administration (FDA) fast track designation for the development program for PRT-201. PRT-201 is being investigated for its ability to improve vascular access in patients Source: www.genengnews.com Rexahn Pharma gets FDA nod to start Phase II Trial of depression drug - RTT News (RTTNews) - Wednesday, biopharmaceutical firm Rexahn Pharmaceuticals, Inc. (RNN: News ), said it received regulatory approval to commence Phase II trial for Serdxin for the treatment of major depressive disorders. Serdxin is being developed as an Source: www.rttnews.com Potential problem drugs listed by FDA - ABC 15 News The government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. Congress ordered the agency to post quarterly listings of medications under Source: www.abc15.com (Adds details from FDA letter, share price) - Reuters WASHINGTON, Sept 8 (Reuters) - U.S. health regulators have warned Forest Laboratories Inc (FRX.N: Quote , Profile , Research , Stock Buzz ) for promoting its hypertension drug Bystolic without properly noting the medication's risk, according to a Source: www.reuters.com Rexahn Pharmaceuticals Receives FDA Approval to Initiate Phase II - Genetic Engineering News Rexahn Pharmaceuticals, Inc. ( AMEX: RNN ), a leader in innovative therapeutics for life-threatening and life-debilitating diseases, announced today that the Company has received FDA approval to begin Phase II trials for Serdaxin(TM), for the Source: www.genengnews.com Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31)
The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28) Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon. T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4) T. Marzetti Company is recalling a limited number of 12 fl. oz. bottles of Girard's Honey Dijon Peppercorn (item 58105) because they may have the incorrect back label of Girard's French Dressing (item 58015). The Girard's Honey Dijon Peppercorn contains eggs, which is not declared as an ingredient on the Girard's French label. People who have allergies to egg run the risk of serious allergic reaction if they consume this product. Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Cardica gets FDA approval for surgical system - Forbes Cardica gets FDA approval for surgical system - Forbes
Surgical systems maker Cardica Inc. said Tuesday the Food and Drug Administration approved its PAS-Port system for use in cardiac bypass surgery. The system creates a secure connection between the body's main artery and vein grafts. Cardiac bypass Source: www.forbes.com Cardica gets FDA nod for bypass surgery device - Forbes - Sept 9 (Reuters) - Cardica Inc said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent before the bell. The medical device maker said Source: www.forbes.com FDA panel mixed on Pfizer bone drug risks - Reuters UK ROCKVILLE, Maryland (Reuters) - Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said Source: uk.reuters.com Pfizer takes more time with antibiotic application - CNBC NEW YORK - Pfizer Inc. said Tuesday it will withdraw approval requests for the antibiotic dalbavancin and conduct another late-stage clinical trial before reapplying. The drug is being developed as a treatment for antibiotic-resistant skin infections Source: www.cnbc.com Entelos seeks shortcuts to bringing drugs to market - San Francisco Business Journal Entelos seeks shortcuts to bringing drugs to market - San Francisco Business Journal
Entelos’ alliance with the FDA on liver damage is unique, says Karis. Biotech executives and financiers know the numbers all too well: 10-plus years and more than $1 billion to take a drug from lab bench to bedside. And a high risk of failure along Source: sanfrancisco.bizjournals.com UPDATE 1-US FDA panel backs Pfizer osteoporosis drug - Reuters ROCKVILLE, Md., Sept 8 (Reuters) - The benefits of a proposed Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) osteoporosis drug outweigh the risks for women past menopause with the bone-thinning disease, a U.S. advisory panel ruled on Source: www.reuters.com Pfizer to Pitch Treatment For Osteoporosis to FDA Panel - Wall Street Journal Pfizer Inc. is due to appear Monday before outside medical experts and Food and Drug Administration officials to make a case for allowing its Fablyn osteoporosis drug on the market. It will be the drug's third go-round, and approval is important for Source: online.wsj.com FDA panel mixed on Pfizer bone drug risks - Reuters ROCKVILLE, Maryland (Reuters) - Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said Source: www.reuters.com US FDA panel mixed on Pfizer bone drug risks - Forbes ROCKVILLE, Md. (Reuters) - Members of a U.S. advisory panel said Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said they Source: www.forbes.com Potential problem drugs listed by FDA - ABC 15 News The government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. Congress ordered the agency to post quarterly listings of medications under Source: www.abc15.com India's Aurobindo Pharma gets tentative US FDA approval for Epzicom - CNBC MUMBAI (Thomson Financial) - India's Aurobindo Pharma Ltd. said it has received tentative approval from the U.S. Food and Drugs Administration (FDA) to manufacture and market Abacavir Sulfate or Lamivudine tablets, used in the treatment of AIDS. In a Source: www.cnbc.com US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug Source: www.guardian.co.uk FDA panel sees Pfizer drug benefit for some women - Reuters ROCKVILLE, Md., Sept 8 (Reuters) - The benefits of a proposed Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) drug outweigh the risks for some women with osteoporosis, a U.S. advisory panel decided on Monday. The panel voted 9-3, with Source: www.reuters.com September 9, 2008MAD MONEY FEATURES - CNBC MAD MONEY FEATURES - CNBC
Companies: Covance Inc. The drug-approval process is getting more and more expensive for Big Pharma these days. The Food & Drug Administration is requiring more clinical trials, and that’s driving already sky-high development costs even higher. But Source: www.cnbc.com FDA panel mixed on Pfizer bone drug risks - Reuters UK FDA panel mixed on Pfizer bone drug risks - Reuters UK
ROCKVILLE, Maryland (Reuters) - Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said Source: uk.reuters.com Remicade tagged with stronger warning. - Pottstown Mercury WASHINGTON - The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The drugs Source: www.pottstownmercury.com Cardica gets FDA nod for bypass surgery device - Forbes - Sept 9 (Reuters) - Cardica Inc said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent before the bell. The medical device maker said Source: www.forbes.com UPDATE 1-Cardica gets FDA nod for bypass surgery device - Reuters Sept 9 (Reuters) - Cardica Inc (CRDC.O: Quote , Profile , Research , Stock Buzz ) said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent Source: www.reuters.com US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug Source: www.guardian.co.uk Pfizer takes more time with antibiotic application - CNBC NEW YORK - Pfizer Inc. said Tuesday it will withdraw approval requests for the antibiotic dalbavancin and conduct another late-stage clinical trial before reapplying. The drug is being developed as a treatment for antibiotic-resistant skin infections Source: www.cnbc.com Cardica gets FDA approval for surgical system - Forbes Surgical systems maker Cardica Inc. said Tuesday the Food and Drug Administration approved its PAS-Port system for use in cardiac bypass surgery. The system creates a secure connection between the body's main artery and vein grafts. Cardiac bypass Source: www.forbes.com Panel cites benefits of Pfizer osteoporosis drug - San Diego Union-Tribune WASHINGTON – An experimental drug from Pfizer could benefit certain women with osteoporosis, federal advisers said Monday, despite concerns of side effects. A Food and Drug Administration panel of experts voted 9-3 that the benefits of Fablyn could Source: www.signonsandiego.com UPDATE 2-US FDA panel backs Pfizer osteoporosis drug - Reuters ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease Source: www.reuters.com FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage Drug Shortage: Fentanyl transdermal patch Availability information updated. FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. Drug Shortage: MVI Adult Injectable Hospira information updated. FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Panel cites benefits of Pfizer osteoporosis drug - San Diego Union-Tribune Panel cites benefits of Pfizer osteoporosis drug - San Diego Union-Tribune
WASHINGTON – An experimental drug from Pfizer could benefit certain women with osteoporosis, federal advisers said Monday, despite concerns of side effects. A Food and Drug Administration panel of experts voted 9-3 that the benefits of Fablyn could Source: www.signonsandiego.com Pfizer takes more time with antibiotic application - CNBC NEW YORK - Pfizer Inc. said Tuesday it will withdraw approval requests for the antibiotic dalbavancin and conduct another late-stage clinical trial before reapplying. The drug is being developed as a treatment for antibiotic-resistant skin infections Source: www.cnbc.com Remicade tagged with stronger warning. - Pottstown Mercury WASHINGTON - The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The drugs Source: www.pottstownmercury.com US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug Source: www.guardian.co.uk Cardica gets FDA approval for surgical system - Forbes Surgical systems maker Cardica Inc. said Tuesday the Food and Drug Administration approved its PAS-Port system for use in cardiac bypass surgery. The system creates a secure connection between the body's main artery and vein grafts. Cardiac bypass Source: www.forbes.com Pfizer Bone Drug Benefits Outweigh Risks, Panel Says (Update2) - Bloomberg Sept. 8 (Bloomberg) -- Pfizer Inc. 's Fablyn, an experimental treatment for women with weak bones, has benefits that outweigh its risks, U.S. advisers said. The Food and Drug Administration panel made the recommendation for postmenopausal women with Source: www.bloomberg.com UPDATE 1-Cardica gets FDA nod for bypass surgery device - Reuters Sept 9 (Reuters) - Cardica Inc (CRDC.O: Quote , Profile , Research , Stock Buzz ) said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent Source: www.reuters.com Cardica gets FDA nod for bypass surgery device - Forbes - Sept 9 (Reuters) - Cardica Inc said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent before the bell. The medical device maker said Source: www.forbes.com UPDATE 2-US FDA panel backs Pfizer osteoporosis drug - Reuters ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease Source: www.reuters.com FDA panel mixed on Pfizer bone drug risks - Reuters UK ROCKVILLE, Maryland (Reuters) - Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Inc drug for osteoporosis increased the chances of dying. Seven members of the Food and Drug Administration committee said Source: uk.reuters.com Drug Shortages: Drugs to be Discontinued; Geref Diagnostic Drug Shortages: Drugs to be Discontinued; Geref Diagnostic
EMD Serono has made a business decision to discontinue this product. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Pacific Consolidated brand Mobile Oxygen Storage Tank Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. FDA to Post Quarterly Report of Potential Safety Issues The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. September 8, 2008FDA posts list of potential problem drugs - Miami Herald FDA posts list of potential problem drugs - Miami Herald
WASHINGTON In an effort to improve communication with doctors and patients on prescription drug safety, the government Friday began posting a list of medications under investigation for potential problems. The first list is a bare-bones compilation Source: www.miamiherald.com Lilly's Brewing Battle With Bristol And Your Emails - CNBC Earlier this week I blogged about the Eli Lilly's "Coming Soon" banner ad I spotted in the online edition of "The New England Journal of Medicine." It's designed to generate buzz about the company's crucial new bloodthinner that could win Food and Source: www.cnbc.com US FDA to list drugs under early safety probes - Forbes United States - WASHINGTON (Reuters) - U.S. health officials will release a new quarterly list of medicines undergoing early reviews of potential side effects, Food and Drug Administration officials said Friday. The list will include drug names and Source: www.forbes.com Remicade tagged with stronger warning. - Pottstown Mercury WASHINGTON - The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The drugs Source: www.pottstownmercury.com US FDA panel backs Pfizer osteoporosis drug - Guardian Unlimited ROCKVILLE, Md., Sept 8 (Reuters) - A Pfizer Inc drug rejected by U.S. regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug Source: www.guardian.co.uk List of medications with potential safety problems - CNBC The list of drugs under investigation by the Food and Drug Administration, what they are used for and the potential problem. _R-Gene 10, a growth hormone, pediatric overdose due to labeling/packaging confusion. _Suprane, an anesthetic, cardiac arrest Source: www.cnbc.com Cymbalta, Tykerb, Tysabri on U.S. drug safety list - Forbes WASHINGTON (Reuters) - U.S. health officials said Friday they are probing safety concerns with Eli Lilly and Co 's antidepressant Cymbalta, GlaxoSmithKline 's cancer drug Tykerb, Biogen Idec and Elan Corp 's multiple sclerosis drug Tysabri and other Source: www.forbes.com FDA posts list of potential problem drugs - Forbes FDA posts list of potential problem drugs - Forbes
The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 medications and the Source: www.forbes.com Part I: Medical device payments to doctors draw scrutiny - Minneapolis Star Tribune D r. David Polly's reputation precedes him and it's worth a lot. Among spine surgeons, this rather unremarkable-looking 51-year-old is a rock star. Arrayed before him as he spoke at the annual Design of Medical Devices Conference at the University of Source: www.startribune.com FDA Demands Tougher Warnings on Immunosuppressive Drugs - BusinessWeek THURSDAY, Sept. 4 (HealthDay News) -- Federal health authorities have asked the manufacturers of four widely used immunosuppressive drugs to bolster safety warnings on the risk of developing opportunistic fungal infections. The drugs, Humira, Cimzia Source: www.businessweek.com Pro-Pharmaceuticals submits data to the FDA - Boston Globe Pro-Pharmaceuticals submits data to the FDA - Boston Globe
Pro-Pharmaceuticals Inc. of Newton said today it has submitted data to federal regulators to support a plan for its Davanat to be considered as part of chemotherapies for the treatment of advanced solid tumors and breast and colorectal cancers Source: www.boston.com FDA to List Drugs Being Investigated: Complaints Will Be Posted - Washington Post FDA to List Drugs Being Investigated: Complaints Will Be Posted - Washington Post
The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. The FDA will name the drug Source: www.washingtonpost.com Irradiation's expansion increases scrutiny of FDA - Fort Lauderdale Sun-Sentinel After two years of food-borne illness outbreaks and recalls of everything from tainted peanut butter to beef, the Food and Drug Administration's decision to allow the irradiation of lettuce and spinach to kill bacteria didn't surprise anyone in the Source: www.sun-sentinel.com India Pharma Ranbaxy Fights FDA Charges - BusinessWeek by Mehul Srivastava Speaking before reporters at one of New Delhi's poshest hotels last month, Ranbaxy Laboratories ( RANB.BO ) CEO and Chairman Malvinder M. Singh was all smiles. Even though his family's company, India's largest drug manufacturer Source: www.businessweek.com FDA posts its first online list of drugs under investigation for - Chicago Tribune WASHINGTON (AP) _ The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 Source: www.chicagotribune.com FDA to begin posting list of drugs under investigation - Seattle Times WASHINGTON — The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. The FDA will Source: seattletimes.nwsource.com FDA lists drugs under scrutiny - Miami Herald for Women and Families. The government on Friday began posting a list of prescription drugs under investigation for potential safety problems so doctors and patients could be better informed. The first list is a bare-bones compilation naming 20 Source: www.miamiherald.com Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production. Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4) T. Marzetti Company is recalling a limited number of 12 fl. oz. bottles of Girard's Honey Dijon Peppercorn (item 58105) because they may have the incorrect back label of Girard's French Dressing (item 58015). The Girard's Honey Dijon Peppercorn contains eggs, which is not declared as an ingredient on the Girard's French label. People who have allergies to egg run the risk of serious allergic reaction if they consume this product. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13) The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label. Mars Petcare US Issues Voluntary Recall of Limited Bags of PEDIGREE Complete Nutrition Small Crunchy Bites at Albertsons in Southern California and Las Vegas due to Potential Salmonella Contamination (August 8) Mars Petcare US today announced a voluntary recall of limited bags of PEDIGREE® Complete Nutrition Small Crunchy Bites sold in Albertsons stores in Southern California and Las Vegas, Nevada. The pet food is being voluntarily recalled because of potential contamination with Salmonella. There have been no complaints or reports of injury resulting from consumption or handling of the recalled product. FDA posts its first online list of drugs under investigation for - Chicago Tribune FDA posts its first online list of drugs under investigation for - Chicago Tribune
WASHINGTON (AP) _ The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients. The first list is a bare-bones compilation naming 20 Source: www.chicagotribune.com FDA to List Drugs Being Investigated - Washington Post The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. The FDA will name the drug Source: www.washingtonpost.com FDA strengthens arthritis drug warnings - Detroit News WASHINGTON -- The Food and Drug Administration Thursday ordered stronger warnings on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The drugs Source: www.detnews.com FDA Plans To Post List Of Drugs Under Investigation - Tampa Bay Online WASHINGTON - The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. The FDA will Source: www2.tbo.com FDA lists drugs under scrutiny - Miami Herald for Women and Families. The government on Friday began posting a list of prescription drugs under investigation for potential safety problems so doctors and patients could be better informed. The first list is a bare-bones compilation naming 20 Source: www.miamiherald.com Stronger warnings issued for 4 arthritis drugs - MSNBC Stronger warnings issued for 4 arthritis drugs - MSNBC
WASHINGTON - The Food and Drug Administration is ordering stronger warnings on four medications used to treat rheumatoid arthritis. The drugs — Humira, Cimzia, Enbrel and Remicade — work by suppressing the immune system, and the FDA says that can Source: www.msnbc.msn.com US FDA to list drugs under early safety probes - Forbes United States - WASHINGTON (Reuters) - U.S. health officials will release a new quarterly list of medicines undergoing early reviews of potential side effects, Food and Drug Administration officials said Friday. The list will include drug names and Source: www.forbes.com FACTBOX: Drugs on U.S. FDA list for possible risks - Reuters (Reuters) - The U.S. Food and Drug Administration on Friday began issuing a list of drugs undergoing safety probes after the agency received reports of health problems. Appearance on the list does not mean the FDA has concluded the drug caused the Source: www.reuters.com FDA Posts List of Potential Problem Drugs - ABC News The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients. For the first time, the U.S. Food and Drug Administration has posted an online Source: www.abcnews.go.com Lilly's Brewing Battle With Bristol And Your Emails - CNBC Earlier this week I blogged about the Eli Lilly's "Coming Soon" banner ad I spotted in the online edition of "The New England Journal of Medicine." It's designed to generate buzz about the company's crucial new bloodthinner that could win Food and Source: www.cnbc.com Store eases baby bottleneck - Chicago Tribune When Georgette Finnie e-mailed What's Your Problem? on Aug. 25, she was 9 months' pregnant with her first child. The expectant mom had done some research about the baby bottles she had received as gifts through her baby registry at Babies "R" Us. All Source: www.chicagotribune.com September 7, 2008Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007) Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007)
This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the publication "Safe Practices in Pa... Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008) This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join... Pacific Consolidated brand Mobile Oxygen Storage Tank Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12) The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites FDA to Post Quarterly Report of Potential Safety Issues The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28) Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon. US FDA to list drugs under early safety probes - Forbes US FDA to list drugs under early safety probes - Forbes
United States - WASHINGTON (Reuters) - U.S. health officials will release a new quarterly list of medicines undergoing early reviews of potential side effects, Food and Drug Administration officials said Friday. The list will include drug names and Source: www.forbes.com Lilly's Brewing Battle With Bristol And Your Emails - CNBC Earlier this week I blogged about the Eli Lilly's "Coming Soon" banner ad I spotted in the online edition of "The New England Journal of Medicine." It's designed to generate buzz about the company's crucial new bloodthinner that could win Food and Source: www.cnbc.com FACTBOX: Drugs on U.S. FDA list for possible risks - Reuters (Reuters) - The U.S. Food and Drug Administration on Friday began issuing a list of drugs undergoing safety probes after the agency received reports of health problems. Appearance on the list does not mean the FDA has concluded the drug caused the Source: www.reuters.com Research Update - MSN MoneyCentral FDA schedules Advisory Committee meeting for liraglutide. Novo Nordisk today announced that the Food and Drug Administration (FDA) has informed the company that an FDA Advisory Committee meeting is scheduled to be held on 2 March 2009 to discuss the Source: news.moneycentral.msn.com Stronger warnings issued for 4 arthritis drugs - MSNBC WASHINGTON - The Food and Drug Administration is ordering stronger warnings on four medications used to treat rheumatoid arthritis. The drugs — Humira, Cimzia, Enbrel and Remicade — work by suppressing the immune system, and the FDA says that can Source: www.msnbc.msn.com Store eases baby bottleneck - Chicago Tribune When Georgette Finnie e-mailed What's Your Problem? on Aug. 25, she was 9 months' pregnant with her first child. The expectant mom had done some research about the baby bottles she had received as gifts through her baby registry at Babies "R" Us. All Source: www.chicagotribune.com FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died. FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007) This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the publication "Safe Practices in Pa... FDA Approves 2008-2009 Flu Vaccines The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. FDA Approves DNA Test to Measure Hepatitis B Virus Levels FDA Approves DNA Test to Measure Hepatitis B Virus Levels
The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections. FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4) CF Sauer Foods Inc, of Richmond, VA is recalling all packages of Gold Medal Spaghetti Sauce Mix with the code date as follows: 8119R. People who have an allergy or severe sensitivity to milkrun the risk of serious or life threatening allergic reaction if they consume these products. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007) This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent report from the Institute for Safe Medication Prac... FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4) T. Marzetti Company is recalling a limited number of 12 fl. oz. bottles of Girard's Honey Dijon Peppercorn (item 58105) because they may have the incorrect back label of Girard's French Dressing (item 58015). The Girard's Honey Dijon Peppercorn contains eggs, which is not declared as an ingredient on the Girard's French label. People who have allergies to egg run the risk of serious allergic reaction if they consume this product. Pfizer's Experimental Drug Is Linked to Excess Deaths (Update3) - Bloomberg Pfizer's Experimental Drug Is Linked to Excess Deaths (Update3) - Bloomberg
Sept. 4 (Bloomberg) -- Pfizer Inc. 's experimental treatment for women with weak bones may increase the chances of death from cancer or stroke, according to new data submitted to U.S. regulators. The risks of the once-a-day tablet, Fablyn, must be Source: www.bloomberg.com List of medications with potential safety problems - International Herald Tribune The list of drugs under investigation by the Food and Drug Administration, what they are used for and the potential problem. _R-Gene 10, a growth hormone, pediatric overdose due to labeling/packaging confusion. _Suprane, an anesthetic, cardiac arrest Source: www.iht.com FDA releases list of drugs under investigation - Forbes In an effort to improve communication with doctors and patients on prescription drug safety, the government Friday began posting a list of medications under investigation for potential problems. The first list is a bare-bones compilation naming 20 Source: www.forbes.com FDA warns that 4 drugs for rheumatoid arthritis raise risk of serious - Chicago Tribune WASHINGTON (AP) _ The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections. The Source: www.chicagotribune.com Reuters Health News Summary - San Diego Union-Tribune NEW YORK (Reuters Health) – Adults who are regularly active, whether through exercise or work, are less likely to develop a range of cancers, a new study suggests. The study, which followed nearly 80,000 Japanese adults for up to a decade, found Source: www.signonsandiego.com FDA Posts List of Potential Problem Drugs - ABC News FDA Posts List of Potential Problem Drugs - ABC News
The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients. For the first time, the U.S. Food and Drug Administration has posted an online Source: www.abcnews.go.com |
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