FDA & Prescription Drugs

• Bayer Suspends Marketing of Trasyol

  Jamie G. Goldstein | November 05, 2007 11:05 AM | 0 CommentsChicago, IL

  The FDA announced today that it has requested Bayer Pharmaceuticals Corporation to suspend its marketing of Traysol. Bayer has agreed to the suspension. Traysol, is used to control patient bleeding during heart surgery, but recent studies have suggested it can cause patients an increased risk of death.The FDA and Bayer are currently working to phase out Traysdol without causing a market...

• Bayer Stops Selling Trasylol

  Joe Saunders | November 05, 2007 9:30 AM | 0 CommentsPinellas, FL

  Succumbing to pressure from industry regulators as well as mounting scientific data, Bayer AG has suspended sale of its antibleeding drug Traylol. The evidence has pointed to a greater than acceptable risk of death as a result of using the drug during heart transplant surgery. Safety issues for the drug began to surface in January 2006 when a report in the New England Journal of Medicine...

• Bayer Pharmaceuticals Corp. Suspends Marketing of Trasylol

  Chrissie Cole | November 05, 2007 1:35 AM | 0 CommentsEastern Massachusetts, MA

  The Food and Drug Administration (FDA) has requested Bayer Pharmaceuticals Corp., halt all marketing of Trasylol, a drug used to stop bleeding during heart surgery. The decision was made to pull the drug off the market following a Canadian study that showed an increased risk of death during use.On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response...

• Drug Company Raided By Feds

  Scott Kappes | November 02, 2007 11:50 AM | 0 CommentsGalveston Bay, TX

  Yesterday federal agents raided a St. Louis drug company after being tipped off that the company was hiding drug products behind a fictitious walls and manufacturing medications under unsanitary conditions. The company, General Therapeutics Corp., produces over the counter medications for both humans and animals, dietary supplements, vitamins, and NC solution. Agents from the FDA and the U.S....

• Background of Medtronic Lead Recalls

  Scott Kappes | November 01, 2007 2:44 PM | 0 CommentsHouston, TX

  The FDA has issued a Class I Recall of Medtronic Sprint Fidelis defibrillator leads due to fracture risk that can result in unwarranted shocks being applied to the implanted patient's heart. In the case of this recall, it seems that physicians at the Minnesota Heart Institute made the company aware of possible problem back in February, when for two days in a row they had patients claim that they...

• Did Medtronic Wait Too Long to Pull Leads?

  Scott Kappes | October 31, 2007 5:29 PM | 0 CommentsHouston, TX

  A story published in the Wall Street Journal claims that Medtronic may have had knowledge of problems with their Sprit Fidelis defibrillator leads as far back as February but did not act until October. Last week the FDA issued a Class I Recall on the leads in question after two reports surfaced of people experiencing unwarranted shocks from their defibrillators. One 65-year-old woman claims that...

• Cephalon Warns that Provigil can Cause Life-Threatening Skin Disease

  Jamie Sheller | October 31, 2007 11:30 AM | 0 CommentsPhiladelphia, PA

  Cephalon recently issued letters to healthcare providers that Provigil can cause life-threatening skin disease including Stevens-Johnson Syndrome. Provigil is a medication for adults who suffer from excessive sleepiness. Common users are adults who have narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Cephalon has revised its warning to instruct patients...

• FDA Adds New Warning to Cellcept Drug

  Jamie Sheller | October 31, 2007 11:26 AM | 0 CommentsPhiladelphia, PA

  Earlier this week, the FDA, along with Roche, the maker of Cellcept, notified healthcare providers that use of Cellcept is associated with pregnancy loss, and increased risk of congenital malfunctions. Specific abnormalities include cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Cellcept is typically given to kidney, heart or liver transplant recipients...

• Cholesterol Drug Linked to Liver Problems

  Joe Saunders | October 31, 2007 9:44 AM | 0 CommentsPinellas, FL

  Japan's Takeda Pharmaceutical Co. is suspending clinical trials of its anti-cholesterol drug known as TAK-475 because of potential side effects concerning the liver. The news comes in the wake of Congressional hearings investigating the FDA's role in monitoring and evaluating pharmaceutical products. One interesting twist thus far in the hearings is how the FDA is supposed to monitor foreign...

• Children's Cold Medicine Recalled Over Dosage Cup

  Shannon Weidemann | October 30, 2007 2:32 PM | 0 CommentsLong Beach, CA

  Over the counter cough and cold medicine has been recalled by Wyeth due to a faulty dosage cup that came with the medicine. The recalled drugs include several Robitussin and Dimetapp brands. The recall comes after an advisory board advised the FDA that cold medications had not been tested on children under the age of six and may not be safe. The products are being removed because they come...