October 11, 2008Food Rules: Labels Must Now Give Origin - ABC News Food Rules: Labels Must Now Give Origin - ABC News
New regulations at U.S. supermarkets are giving consumers the knowledge they have been asking for—where the fresh food they buy originates. A sticker shows the country of origin of an avocado in San Rafael, California. (Justin Sullivan/Getty Images Source: abcnews.go.com Study: Risky drug samples given to kids - Seattle Times A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children's health at risk. The study, being published today in the journal Pediatrics, analyzed an in-depth survey Source: seattletimes.nwsource.com FDA Launches Food Defense Awareness Training Kit for Employees in the - WebWire FIRST tool kit teaches how to reduce the risks of food contamination Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense Source: www.webwire.com Supreme Court to tackle cigarette, drug issues - MSNBC In their new term beginning Monday, the justice of the U.S. Supreme Court will be asked to decide how much authority state courts should have in granting big damage awards against the makers of prescription drugs and cigarettes. They also face Source: www.msnbc.msn.com US clears drug for swelling disease - ONE News US health regulators have approved Lev Pharmaceuticals Inc's experimental drug to treat a rare genetic disease that causes swelling of the hands, feet and other parts of the body. The drug, called Cinryze, aims to treat hereditary angioedema, a Source: tvnz.co.nz One agency to rule them all - New Straits Times Definitely, says Associate Professor Dr Ayub Mohd Yatim, head of Universiti Kebangsaan Malaysia's Food Cleanliness and Safety Training Academy. "At present, we have many different agencies handling food issues -- Health Ministry, Agriculture and Agro Source: www.nst.com.my Viread for chronic hepatitis B in adults - Xagena Medical News Viread for chronic hepatitis B in adults - Xagena Medical News
The FDA ( Food and Drug Administration ) has approved Viread ( Tenofovir disoproxil fumarate ) for the treatment of chronic hepatitis B, a serious liver disease caused by the hepatitis B virus ( HBV ). Chronic hepatitis B is the leading cause of Source: www.xagena.it Study: Risky drug samples given to kids - Seattle Times A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children's health at risk. The study, being published today in the journal Pediatrics, analyzed an in-depth survey Source: seattletimes.nwsource.com Study Says Drug Samples May Endanger Children - The Ledger A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children’s health at risk. The study, being published Monday in the journal Pediatrics, analyzed an in-depth Source: www.theledger.com Safe food on the table - New Straits Times IN this day and age, when enlightened citizens and public servants are expected to cast a wary and watchful eye on the unscrupulous, we are visited by the melamine-tainted milk scandal where four babies have died and many thousands made ill in China Source: www.nst.com.my Supreme Court to tackle cigarette, drug issues - MSNBC In their new term beginning Monday, the justice of the U.S. Supreme Court will be asked to decide how much authority state courts should have in granting big damage awards against the makers of prescription drugs and cigarettes. They also face Source: www.msnbc.msn.com Pro-Pharmaceuticals announces FDA meeting - Boston Globe Pro-Pharmaceuticals Inc. of Newton announced today that a pre-New Drug Application meeting with the US Food and Drug Administration is scheduled for December 22nd to discuss Davanat. Davanat, a company drug candidate, is designed for use as a Source: www.boston.com Study questions safety of free drug samples for children - Boston Globe Children who receive free samples of prescription drugs from their doctors may be risking safety problems, a new study says. Four of the 15 medications most frequently given out as free samples to more than 10,000 children in a 2004 national survey Source: www.boston.com FDA Launches Food Defense Awareness Training Kit for Employees in the - WebWire FIRST tool kit teaches how to reduce the risks of food contamination Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense Source: www.webwire.com Family Blames Soldier's Suicide on Anti-Malaria Drug: Lariam Known to - Washington Post CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John" M. Torres, had killed himself in Afghanistan just weeks before he was to return home in July 2004. He figured that John, 25, was murdered because of his opposition to the Source: www.washingtonpost.com Plastics with BPA may impact health d-burton - Joplin Independent Bisphenol A, also known as BPA, is a chemical used to make plastic food and beverage containers, dental sealants and the resin lining in cans. The Food and Drug Administration has concluded that exposure to BPA from food-grade plastics is below Source: www.joplinindependent.com Drug Shortage: MVI Adult Injectable Drug Shortage: MVI Adult Injectable
Hospira information updated. McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30) The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch. Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1) The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date. NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26) NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides (“to be weighed at time of sale”) sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. 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. FDA to Continue Review of Alogliptin NDA - Forbes FDA to Continue Review of Alogliptin NDA - Forbes
PPD, Inc. (Nasdaq: PPDI) today announced that Takeda Pharmaceutical Company Limited reported that Takeda Global Research and Development Center, Inc., a wholly owned U.S. subsidiary, received notification that the U.S. Food and Drug Administration Source: www.forbes.com Supreme Court on the FDA - Lewrockwell.com NPR lays out the upcoming docket for the Supreme Court. There's a theme in the cases highlighted: the executive branch should be able to do whatever it wants. Let's look at the FDA case as an example. You can't sell a drug in the US unless you get Source: www.lewrockwell.com FDA: No quick decision on cold medicines for kids - Miami Herald WASHINGTON -- A top government health official Thursday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm. But Food and Drug Administration Source: www.miamiherald.com FDA: Traces of melamine are not harmful in foods - Detroit News WASHINGTON -- Tiny traces of melamine, the chemical that has set off a global food safety scare, are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said Friday its safety experts have Source: www.detnews.com ATryn(R) (antithrombin alfa) BLA Filing Accepted by FDA - Forbes OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ATryn(R) (antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in Source: www.forbes.com FDA: Melamine unacceptable - Morris County Daily Record No level of the chemical melamine, which has been found in milk from China, is acceptable in baby formula, the Food and Drug Administration has ruled. In other foods, only a tiny amount -- 2.5 parts per million -- is considered acceptable, the agency Source: www.dailyrecord.com BRIEF-MedX Health wins FDA clearance for Oralase - Forbes Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com Key FDA role on cold-remedy guidelines for kids - San Francisco Gate Saturday, October 11, 2008 Because the Food and Drug Administration suggested that, too. FDA officials proposed the cutoff earlier this year in private discussions with the industry, government and industry officials confirmed Friday. The companies Source: www.sfgate.com Pro-Pharmaceuticals announces FDA meeting - Boston Globe Pro-Pharmaceuticals Inc. of Newton announced today that a pre-New Drug Application meeting with the US Food and Drug Administration is scheduled for December 22nd to discuss Davanat. Davanat, a company drug candidate, is designed for use as a Source: www.boston.com Study questions safety of free drug samples for children - Boston Globe Study questions safety of free drug samples for children - Boston Globe
Children who receive free samples of prescription drugs from their doctors may be risking safety problems, a new study says. Four of the 15 medications most frequently given out as free samples to more than 10,000 children in a 2004 national survey Source: www.boston.com Study: Risky drug samples given to kids - Seattle Times A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children's health at risk. The study, being published today in the journal Pediatrics, analyzed an in-depth survey Source: seattletimes.nwsource.com FDA Launches Food Defense Awareness Training Kit for Employees in the - WebWire FIRST tool kit teaches how to reduce the risks of food contamination Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense Source: www.webwire.com South Korea orders 4 more Chinese-made food products tainted with - Newsday SEOUL, South Korea (AP) _ South Korea's food watchdog has ordered four more Chinese-made food products to be destroyed after they were found to contain the industrial chemical melamine. Melamine was found in Snickers Peanut Funsize and M&Ms chocolate Source: www.newsday.com Supreme Court to tackle cigarette, drug issues - MSNBC In their new term beginning Monday, the justice of the U.S. Supreme Court will be asked to decide how much authority state courts should have in granting big damage awards against the makers of prescription drugs and cigarettes. They also face Source: www.msnbc.msn.com Pro-Pharmaceuticals announces FDA meeting - Boston Globe Pro-Pharmaceuticals Inc. of Newton announced today that a pre-New Drug Application meeting with the US Food and Drug Administration is scheduled for December 22nd to discuss Davanat. Davanat, a company drug candidate, is designed for use as a Source: www.boston.com Food Rules: Labels Must Now Give Origin - ABC News New regulations at U.S. supermarkets are giving consumers the knowledge they have been asking for—where the fresh food they buy originates. A sticker shows the country of origin of an avocado in San Rafael, California. (Justin Sullivan/Getty Images Source: abcnews.go.com Focus on food safety fundamentals - Taipei Times THE MELAMINE-CONTAMINATED milk powder scandal has shaken Taiwan¡¦s food industry and has scared the living daylights out of the public. However, prior to this incident, there were many warning signs such as poor quality starch, poisonous hairy Source: www.taipeitimes.com Food Safety - Chicago Tribune WASHINGTON (AP) _ The government is urging consumers to thoroughly cook frozen chicken dinners after 32 people in 12 states were sickened with salmonella poisoning. The health warning by the U.S. Department of Agriculture cited frozen dishes in which Source: www.chicagotribune.com Infant Formula Manufactured in China Contaminated With Melamine Infant Formula Manufactured in China Contaminated With Melamine
UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves. Tiotropium (marketed as Spiriva HandiHaler) UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Biodel Announces Timing of FDA Discussions on VIAject(TM) - MSN MoneyCentral Biodel Announces Timing of FDA Discussions on VIAject(TM) - MSN MoneyCentral
Biodel Inc. BIOD announced today that it will meet with officials from the U.S. Food and Drug Administration ’ s (FDA) Division of Metabolic and Endocrine Drug Products by the end of January 2009 to discuss the submission of a new drug application Source: news.moneycentral.msn.com US clears Lev Pharma drug for rare swelling disease - Reuters WASHINGTON, Oct 10 (Reuters) - U.S. health regulators on Friday approved Lev Pharmaceuticals Inc's (LEVP.OB: Quote , Profile , Research , Stock Buzz ) experimental drug to treat a rare genetic disease that causes swelling of the hands, feet and other Source: www.reuters.com Can Botox beat hot, stinky feet? - St. Petersburg Times Let's face it, BO is one of our greatest fears. We check ourselves, making sure we got everything right. Lord, help us if we didn't. The cosmetic industry tries to help us with deodorants and powders for everyone: scented, unscented, potpourri. Then Source: www.tampabay.com South Korea orders 4 more Chinese-made food products tainted with - Newsday SEOUL, South Korea (AP) _ South Korea's food watchdog has ordered four more Chinese-made food products to be destroyed after they were found to contain the industrial chemical melamine. Melamine was found in Snickers Peanut Funsize and M&Ms chocolate Source: www.newsday.com FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar - WebWire AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the Source: www.webwire.com Limit on cold remedies for kids was FDA's idea - MSNBC WASHINGTON - When drug makers made a surprise announcement this week that they no longer recommend cough and cold remedies for youngsters under 4 , they didn't let on that it was the government's idea. And why age 4 rather than the age 6 that Source: www.msnbc.msn.com October 10, 2008Bottled Water Everywhere: Keeping it Safe 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. QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26) QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine. Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30) The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? 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. NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26) NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26)
NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides (“to be weighed at time of sale”) sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes. Mom's Food Products, Inc. Issues Allergy Alert On Undeclared Eggs in Sandwiches and Potato Salad (September 23) Mom's Food Products, Inc. of Ft Worth, TX is recalling all Tuna Salad sandwiches, Pimento Cheese sandwiches, and potato salad because they may contain eggs in the salad dressing. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. Tarceva (erlotinib) Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1) The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. October 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Is It Really FDA Approved? Is It Really FDA Approved?
Some marketers say their products are "FDA approved", but how can you know for sure? 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. FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. Victory predicted for FDA powers on tobacco - Inrich.com Victory predicted for FDA powers on tobacco - Inrich.com
A proposal to give the Food and Drug Administration the power to regulate tobacco products appears dead for the year, but anti-smoking advocates say they expect it to pass in 2009. The measure passed the House this summer with overwhelming support Source: www.inrich.com Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Statin drugs and amyotrophic lateral sclerosis (ALS) New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS. Over The Counter Cough and Cold Medications Product labels being modified to state "do not use" in children under 4 years of age. FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. October 9, 2008Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek
Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com FDA to List Drugs - 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 targets 2 eye products - Chicago Tribune The federal government told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with the products. The Food and Drug Source: www.chicagotribune.com FDA blocks imports from India's generic drug giant - FOX News WASHINGTON — The government closed U.S. borders Tuesday to more than 30 generic drugs _ including popular antibiotics and cholesterol medicines _ made by India's biggest pharmaceutical company, citing poor quality in two of its factories. The Food Source: www.foxnews.com FDA hires 1,300 new doctors and scientists - Washington Post 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.washingtonpost.com Ranbaxy Shaken By FDA Action - Forbes Ranbaxy Laboratories responded with shock Wednesday to the U.S. Food and Drug Administration's actions to limit the importation of its drugs into the U.S. "Ranbaxy is very disappointed in the action FDA has taken. The company has responded to each Source: www.forbes.com India Pharma Ranbaxy Fights FDA Probe - 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 Scientists, FDA face off over safety of BPA in consumer plastics - USA Today BPA is used in lightweight, durable plastics. Products include some baby bottles, sippy cups and reusable food and drink containers, such as reusable sports water bottles and Tupperware, compact discs, DVDs, eyeglass lenses and sports safety goggles Source: www.usatoday.com FDA Tests Gilead's Patience - Forbes Gilead Sciences had a minor setback this week, but it's nothing that the company can't handle, analysts said. The Foster City, Calif.-based pharmaceutical company said it received a letter from the U.S. Food and Drug Administration asking for more Source: www.forbes.com FDA Approves New Injection Site for RISPERDAL(R) CONSTA(R) for - MSN MoneyCentral Alkermes, Inc. ALKS today announced that patients with schizophrenia now have a new administration option for RISPERDAL ® CONSTA ® [ (risperidone) Long-Acting Injection ] . The U.S. Food and Drug Administration (FDA) has approved a new injection Source: news.moneycentral.msn.com Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
See information in Related Information section. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. 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. 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. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1) Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1)
The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date. Wegmans Expands Dates of Bagel Recall and Includes Additional Bakery Products (September 11) Wegmans Food Markets, Inc. has expanded the voluntary recall of in-store made bagels and bialys first announced on Wednesday, September 10. The recall is now expanded to include Challah bread and in-store baked bagels, bialys and rolls. These products were sold in Wegmans' bakery department between June 19 and September 11, 2008. Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30) The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch. Mars Petcare US Issues Voluntary Recall of Everson, PA Plant Dry Pet Food Product due to Potential Salmonella Contamination (September 12) Mars Petcare US announced a voluntary recall of products manufactured at its Everson, Pennsylvania facility. The pet food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund. This voluntary recall only affects the United States. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3) Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine. FDA Detects Melamine Contamination in Flavored Drink FDA Detects Melamine Contamination in Flavored Drink
The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6) New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. 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. CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24) CaJohns Fiery Foods Company is recalling a total of 103 individual bottles of HDH Grillin' Sauce sold between the dates of 01/01/07 and 09/15/08. This recall is initiated due to the possibility of non-declared contents on the Ingredient Declaration. The products contain the listed Worcestershire Sauce, but may not be parenthetically listed as to it's ingredients one of which is Anchovies, a serious allergen to specific individuals. These products also contain the listed Soy Sauce, but may not be parenthetically listed as to it's ingredients. Soy Sauce contains Soybeans and Wheat which are serious allergens to specific individuals. 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. Statin drugs and amyotrophic lateral sclerosis (ALS) New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS. QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26) QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine. Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores. 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. Tainted milk: 10,000 Chinese kids still ailing as government imposes - Chicago Tribune Tainted milk: 10,000 Chinese kids still ailing as government imposes - Chicago Tribune
BEIJING (AP) _ More than 10,000 children remained hospitalized after being sickened in China's tainted milk scandal, eight of whom were in serious condition, officials said. The Health Ministry said in a statement on its Web site Wednesday that 10 Source: www.chicagotribune.com Lack of Funding Forces Closure of Food Supply Safety Program - Forbes WASHINGTON, Oct. 2 /PRNewswire/ -- Despite extensive efforts by America's veterinarians to convince the US Congress, the US Department of Agriculture, and the Food and Drug Administration to provide long-term funding, a critical food safety resource Source: www.forbes.com China suspends sale and use of herbal injection after adverse - In-Forum China has suspended the sale and use of an injectable herbal remedy after six people suffered adverse reactions, including three who died. The State Food and Drug Administration said in a notice posted late Wednesday that the six suffered "serious Source: www.in-forum.com Medtronic warns doctors of drug pump problems - BusinessWeek Medtronic has warned physicians about issues with some of its implantable drug pump systems that have been linked to one patient death and dozens of other problems. The Food and Drug Administration on Thursday posted a notice about problems with the Source: www.businessweek.com Watson gets FDA approval for BPH drug - MSN MoneyCentral CORONA, Calif. (AP) - Watson Pharmaceuticals Inc. said late Wednesday the Food and Drug Administration approved its drug Rapaflo for the treatment of urinary problems. The drug is approved as a treatment for BPH, or benign prostatic hyperplasia Source: news.moneycentral.msn.com Ginseng jabs kill three in Yunnan - BBC Asia-Pacific The deaths, announced on China's health ministry web site, occurred in Yunnan province after six hospital patients received the injections. It said sales and use of the ginseng extract had been suspended. The ministry is also trying to dampen fears Source: news.bbc.co.uk Phase Forward to Share Expertise at DIA Clinical Forum and CReaTE 08 - Forbes Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that it will participate in two key global events in October: the DIA Clinical Forum, to be held in Ljubljana, Slovenia Source: www.forbes.com 10,000 Chinese children still sick from milk - Philadelphia Inquirer BEIJING - More than 10,000 children remained hospitalized after being sickened in China's tainted milk scandal, eight of whom were in serious condition, officials said. The Health Ministry said in a statement on its Web site Wednesday that 10,666 Source: www.philly.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. FDA Law Enforcers Protect Consumers' Health Inside the FDA's Office of Criminial Investigations Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. 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. October 8, 2008Drug companies: No cold medicine for kids under 4 - Newsday Drug companies: No cold medicine for kids under 4 - Newsday
WASHINGTON - Children under 4 should not be given over-the-counter cough and cold remedies, drug companies said yesterday in a concession to pediatricians who doubt the drugs do much and worry about risks. The voluntary change in advice to parents Source: www.newsday.com FDA clears Neuronetics’ depression therapy - Philadelphia Inquirer Medical-device company Neuronetics Inc., of Malvern, today said the U.S. Food and Drug Administration has cleared its "transcranial magnetic stimulation" therapy system for the treatment of depression. The system will be introduced on a limited basis Source: www.philly.com FDA cracks down on eye wash and skin cream - FOX News FDA cracks down on eye wash and skin cream - FOX News
WASHINGTON — Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash, known Source: www.foxnews.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com FDA targets 2 eye products - Chicago Tribune The federal government told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with the products. The Food and Drug Source: www.chicagotribune.com FDA hires 1,300 new doctors and scientists - Washington Post 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.washingtonpost.com India Pharma Ranbaxy Fights FDA Probe - 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 Tarceva (erlotinib) Tarceva (erlotinib)
Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Relates information section 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. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. 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 Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. 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. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26) NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26)
NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides (“to be weighed at time of sale”) sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes. 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. Lumen Biomedical Receives FDA Clearance of Embolectomy System for - Forbes Lumen Biomedical Receives FDA Clearance of Embolectomy System for - Forbes
Lumen Biomedical, Inc., a Minnesota-based medical device company, announced today receipt of FDA clearance for the LBI Embolectomy System for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. The LBI Source: www.forbes.com Drugmakers Issue Warning - Washington Post Resize The makers of cold and cough medications announced yesterday they are voluntarily warning parents not to give their products to children younger than 4, a move negotiated in private with federal drug regulators over the past six months Source: www.washingtonpost.com Cold medicines taboo for kids under 4 - Miami Herald Drug manufacturers said Tuesday that over-the-counter cold medicines should not be given to children under 4, acknowledging pediatricians' and health officials' concerns. The Consumer HealthCare Products Association said labels saying ''do not use Source: www.miamiherald.com Are bird droppings the secret to Posh Spice and David Beckham's good - New York Daily News David & Victoria Beckham in New York last month. It's no longer a secret that celebrities have some strange beauty habits. But are bird dropping facials really the next big thing? Victoria and David Beckham are the latest duo said to have joined in Source: www.nydailynews.com FDA Takes End Run to Award PR Contract - Washington Post The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products. FDA leaders decided to hire a contractor for a public Source: www.washingtonpost.com Firm to offer test to detect genetic risk of breast cancer - Houston Chronicle WASHINGTON — A biotech company today will begin offering the first genetic test to assess a woman's risk for the most common forms of breast cancer, reigniting debate about the growing number of unregulated genetic tests. The test by deCODE Source: www.chron.com E-mails suggest Pfizer tried to suppress study on drug - Boston Globe Top drug company marketing executives suppressed a large European study suggesting their blockbuster medication Neurontin was ineffective for chronic nerve pain, and they privately strategized about how to silence a British researcher who wanted to Source: www.boston.com Cold-medicine makers issue warning for kids under 4 - Seattle Times WASHINGTON — The makers of cold and cough medicines said Tuesday they are voluntarily warning parents not to give their products to children younger than 4, a move negotiated in private with federal drug regulators during the past six months Source: seattletimes.nwsource.com Drugmakers promise to relabel cold remedies as wrong for kids under 4 - Baltimore Sun The makers of cold and cough medicines said yesterday that they will stop marketing over-the-counter remedies to children under 4 - acting amid an extensive federal review of whether the drugs are safe and effective for children under 12. The Source: www.baltimoresun.com Kids under 4 shouldn’t get cold medicines - Tacoma News Tribune Kids under 4 shouldn’t get cold medicines - Tacoma News Tribune
WASHINGTON – Don’t give over-the-counter cold remedies to kids under 4, drug companies said Tuesday. What sniffling little ones need, doctors said, is plenty of fluids and lots of tender, loving care. “The best thing a parent can do is comfort Source: www.thenewstribune.com Suit Alleges Pfizer Spun Studies - Wall Street Journal Suit Alleges Pfizer Spun Studies - Wall Street Journal
Pfizer Inc. marketers urged the suppression of medical studies that reached unfavorable conclusions about the effectiveness of the company's big-selling drug Neurontin, according to internal Pfizer documents submitted in a lawsuit against the company Source: online.wsj.com No cold medicines for kids under 4 - Times of India WASHINGTON: Don't give over-the-counter cold remedies to kids under 4, drug companies said on Tuesday. What sniffling little ones need, doctors said, are plenty of fluids and lots of tender, loving care. "The best thing a parent can do is comfort Source: timesofindia.indiatimes.com Drug firms warn about cold medicine for kids under 4 - Miami Herald Drug manufacturers said Tuesday that over-the-counter cold medicines should not be given to children under 4, acknowledging pediatricians' and health officials' concerns. The Consumer HealthCare Products Association said labels saying ''do not use Source: www.miamiherald.com German stocks - Factors to watch on Oct 8 - Reuters Two television commercials for Bayer's birth control pill Yaz give a misleading impression of its benefits and minimise the drug's risks, the U.S. Food and Drug Administration said. [ID:nN07476709] Related news [BAYG.DE-E] HYPO REAL ESTATE (HRXG.DE Source: www.reuters.com Drug labels get new warning - Herald Tribune Manufacturers of pediatric cough and cold medicines said Tuesday that they would voluntarily change their products' labels to say that they should not be used in children under age 4. In addition, products with certain antihistamines will get new Source: www.heraldtribune.com Cold meds not for kids - Detroit News WASHINGTON -- Don't give over-the-counter cold remedies to kids under 4, drug companies said Tuesday. What sniffling little ones need, doctors said, are plenty of fluids and lots of tender, loving care. "The best thing a parent can do is comfort Source: www.detnews.com Unregulated Drug Test Reignites Debate - Washington Post A biotech company today will begin offering the first genetic test to assess a woman's risk for the most common forms of breast cancer, reigniting debate about the growing number of unregulated genetic tests. The test by Decode Genetics of Reykjavik Source: www.washingtonpost.com Drugmakers: No Cold Remedies for Kids Under 4 - Washington Post The makers of cold and cough medications announced yesterday they are voluntarily warning parents not to give their products to children younger than 4, a move negotiated in private with federal drug regulators over the past six months. Medications Source: www.washingtonpost.com October 7, 2008Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
See Relates information section Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage FDA hires 1,300 new doctors and scientists - Washington Post FDA hires 1,300 new doctors and scientists - Washington Post
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.washingtonpost.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com FDA Tests Gilead's Patience - Forbes Gilead Sciences had a minor setback this week, but it's nothing that the company can't handle, analysts said. The Foster City, Calif.-based pharmaceutical company said it received a letter from the U.S. Food and Drug Administration asking for more Source: www.forbes.com FDA cracks down on eye wash and skin cream - FOX News WASHINGTON — Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash, known Source: www.foxnews.com FDA to List Drugs - 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 blocks imports from India's generic drug giant - FOX News WASHINGTON — The government closed U.S. borders Tuesday to more than 30 generic drugs _ including popular antibiotics and cholesterol medicines _ made by India's biggest pharmaceutical company, citing poor quality in two of its factories. The Food Source: www.foxnews.com Scientists, FDA face off over safety of BPA in consumer plastics - USA Today BPA is used in lightweight, durable plastics. Products include some baby bottles, sippy cups and reusable food and drink containers, such as reusable sports water bottles and Tupperware, compact discs, DVDs, eyeglass lenses and sports safety goggles Source: www.usatoday.com India Pharma Ranbaxy Fights FDA Probe - 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 Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution
See Web site for additional information on this current drug shortage Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. 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. Safety and Food Packaging FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. 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. 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. Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... FDA Law Enforcers Protect Consumers' Health Inside the FDA's Office of Criminial Investigations FDA Drug Safety Newsletter FDA Drug Safety Newsletter
Summer 2008 edition available for healthcare professionals and the medical community. Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma... Recalls and Safety Alerts: Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion. Although FDA has approved two rhBMP products for very specific me... Recalls and Safety Alerts: Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon r... Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Recalls and Safety Alerts: Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injec... Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and... October 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Epoetin alfa Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. October 6, 2008Nobel Prize to HPV Researcher Highlights Importance of Cervical Cancer - MSN MoneyCentral Nobel Prize to HPV Researcher Highlights Importance of Cervical Cancer - MSN MoneyCentral
- QIAGEN's HPV testing technologies are a successful commercialization of VENLO, Netherlands , October 6 /PRNewswire/ -- The Nobel Prize-winning discovery of the causal link between human papillomavirus (HPV) and cervical cancer has spurred Source: news.moneycentral.msn.com FDA urged to recall child cold medicines - CNBC Doctors question safety of over-the-counter drugs for kids under 6 WASHINGTON - With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question Source: www.cnbc.com FDA targets 2 eye products - Chicago Tribune FDA targets 2 eye products - Chicago Tribune
The federal government told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with the products. The Food and Drug Source: www.chicagotribune.com FDA hires 1,300 new doctors and scientists - Washington Post 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.washingtonpost.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com Free prescription drug samples carry risks for children - eMaxHealth.com Free prescription drug samples carry risks for children - eMaxHealth.com
First of its kind study finds safety concerns in frequently distributed free drug samples. Free prescription drug samples distributed to children may be unsafe, according to a study by physicians from Cambridge Health Alliance and Hasbro Children's Source: www.emaxhealth.com South Korea finds melamine in 10 China-made products - Reuters SEOUL, Oct 6 (Reuters) - South Korea's food watchdog said on Monday it had found melamine in 10 Chinese dairy products and ordered them to be taken off shelves. "The levels of melamine found in those products do not pose a big health threat but we'll Source: www.reuters.com Lecturer tackles TV dinners and barbecues as subject of research - University Daily Kansan Photo by Julianne Kueffer After researching the history of American food, which looks at the kinds of foods people ate and how they reflected the cultural shifts during 1950s, Tim Miller, KU history lecturer, is ready to take on his next topic Source: www.kansan.com S KOREAN WATCHDOG DETECTS MELAMINE IN CHOCOLATES FROM CHINA - TradingMarkets.com The Korea Food and Drug Administration (KFDA) said 2.38 parts-per millimeter (ppm) and 1.78 ppm of the toxic substance was discovered each in one sample of M&M's Milk and Peanut Snickers Fun Size products from Mars Korea. A Kit Kat bar from Nestle Source: www.tradingmarkets.com More Snacks Found to Contain Melamine - Digital Chosunilbo The Korea Food and Drug Administration has found the industrial chemical melamine in four additional products made by multinational confectionaries and Korea¡¯s Lotte, bringing the total to 10 as of Sunday. The KFDA on Saturday said melamine was Source: english.chosun.com Free drug samples carry risks for children - Genetic Engineering News Cambridge, MA Free prescription drug samples distributed to children may be unsafe, according to a study by physicians from Cambridge Health Alliance and Hasbro Children's Hospital. The national study, the first to look at free drug sample use Source: www.genengnews.com More Chinese Kimchi Gets the Thumbs-Down - Digital Chosunilbo The amount of Chinese-made kimchi declared unfit for import by the Korean Customs Office last year increased almost six times since 2005, when a parasite scare swept Korea. According to data submitted by the Korea Food and Drug Administration to GNP Source: english.chosun.com High court term begins quietly in campaign season - Boston Globe WASHINGTON - The Supreme Court is doing its best to stay out of the spotlight in the final days of the presidential campaign. It opens its new term today with no cases on race, abortion, or other social issues that might split the court and the Source: www.boston.com On the Supreme Court's docket - Elkhart Truth Vermont musician Diana Levine won a $6.8 million judgment against drugmaker Wyeth after having part of her right arm amputated in 2000 when an anti-nausea drug was injected improperly. Now Wyeth, backed by the Bush administration, wants the high Source: www.etruth.com October 5, 2008FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Doctors want FDA to halt cold medicines for kids - Reuters India Doctors want FDA to halt cold medicines for kids - Reuters India
BELTSVILLE, Maryland (Reuters) - Over-the-counter cough and cold medicines should not be sold for young children because they are unproven and can be dangerous, doctors and consumer advocates said on Thursday, despite objections from industry Source: in.reuters.com FDA: Low amounts of melamine, safe - Presstv US FDA safety experts have recently reported that except for baby formula, small traces of melamine are not troublesome in other foods. Recently, melamine-tainted baby formula has sickened thousands of Chinese babies, leading to several deaths caused Source: www.presstv.ir TorreyPines Therapeutics Reports Successful End-of-Phase II Meeting - MSN MoneyCentral LA JOLLA, Calif. , Oct. 1 /PRNewswire/ -- TorreyPines Therapeutics, Inc. TPTX today announced that it held a successful End-of-Phase II meeting for tezampanel with the U.S. Food and Drug Administration (FDA) on September 29, 2008 . Based on a review Source: news.moneycentral.msn.com FDA: No quick decision on cold medicines for kids - Miami Herald WASHINGTON -- A top government health official Thursday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm. But Food and Drug Administration Source: www.miamiherald.com Doctors want US FDA to halt cold medicines for kids - Forbes BELTSVILLE, Md. (Reuters) - Over-the-counter cough and cold medicines should not be sold for young children because they are unproven and can be dangerous, doctors and consumer advocates said Thursday, despite objections from industry representatives Source: www.forbes.com Merck’s Discontinuation On Taranabant Development - Eflux Media Merck’s Discontinuation On Taranabant Development - Eflux Media
Merck & Co. has decided to bring to an end the development the experimental obesity drug taranabant on account of its many adverse events, a statement from the company says. The pharmaceutical company said on Thursday that the efficiency and side Source: www.efluxmedia.com 'Supreme' drug court - Star-Democrat Is there anyone left in America who still thinks that just because a medication is approved for sale by the U.S. Food and Drug Administration it's perfectly safe and without product defects? If so, he or she should type the words "heparin recall" or Source: www.stardem.com CaridianBCT Initiates Clinical Trial for Whole Blood Process with - Forbes CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced today that it has initiated a clinical trial for Source: www.forbes.com More 'inedible' kimchi barred - Straits Times SEOUL - SOUTH Korea has declared a rising volume of Chinese imported kimchi, or spicy fermented cabbage, to be inedible due to banned or harmful additives found in it, officials said on Sunday. The Korea Food and Drug Administration told parliament Source: www.straitstimes.com FDA: Tiny bit of melamine in food usually OK - Citizen WASHINGTON (AP) _ Eating a tiny bit of a melamine, the chemical responsible for a global food safety scare, is not harmful except when it's in baby formula, U.S. food safety officials said Friday. Melamine-tainted formula has sickened more than 54 Source: www.citizen.com Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
See Web site for additional information 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. 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. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Safety and Food Packaging FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease. FDA: No quick decision on cold medicines for kids - NWITimes.com FDA: No quick decision on cold medicines for kids - NWITimes.com
WASHINGTON - A top government health official Thursday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm. But Food and Drug Administration Source: nwitimes.com Major Supreme Court cases for the new term - Myrtle Beach Online Highlights of some high-profile cases that the Supreme Court will take up in its term that begins Monday: Drugmaker liability | Vermont musician Diana Levine won a $6.8 million judgment against drugmaker Wyeth after having part of her right arm Source: www.myrtlebeachonline.com Latest Research Supports New AIDS Drug - Forbes WEDNESDAY, Oct. 1 (HealthDay News) -- New research offers more evidence that a new class of AIDS drug can provide major benefits for certain patients who have become immune to existing medications. The U.S. Food and Drug Administration approved Source: www.forbes.com South Korea finds 4 more melamine-tainted products - NWITimes.com SEOUL, South Korea - South Korea's food watchdog has ordered four more Chinese-made food products to be destroyed after they were found to contain the industrial chemical melamine. Melamine was found in Snickers Peanut Funsize and M&Ms chocolate milk Source: nwitimes.com 60' note may back Stewart's story - Baltimore Sun NEW YORK - Congressional investigators have obtained a document from Merrill Lynch that sheds light on style guru Martha Stewart's alleged early plans to sell her ImClone Systems Inc. stock. It mentions $60 -- the price at which Stewart says she Source: www.baltimoresun.com More nations pull suspect - Manila Times SEOUL: South Korea, Australia and Japan Saturday pulled melamine-contaminated sweets and drinks from supermarket shelves amid a widening scandal over Chinese milk products tainted with the toxic chemical. Authorities in Seoul ordered Mars and Nestlé Source: www.manilatimes.net |
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