FDA & Prescription Drugs

• Tysabri Linked to Liver Damage

  Scott Kappes | February 29, 2008 10:18 AM | 0 CommentsHouston, TX

  This week federal health officials updated the prescribing information of Tysabri to warn of a possible link to severe and potentially fatal liver damage. Tysabri, used to treat multiple sclerosis, was recently approved to treat Crohn's disease, but now officials say that a patient can begin to experience liver damage within six days of the first dose of the drug. Tysabri was pulled from the...

• Trasylol Contributed to 1,000 Deaths a Month

  Scott Kappes | February 27, 2008 4:29 PM | 0 CommentsHouston, TX

  A couple of weeks ago the popular news program "60 Minutes" aired a story on Bayer's Trasylol. The broadcast told the tragic story of Joseph Randone and his experiences following heart surgery where Trasylol was used to reduce bleeding during the surgery. Physicians told the Randone family that the risk associated with the surgery was around five percent and that Joe would likely be able to...

• Trasylol Linked to Over 20,000 Deaths

  Scott Kappes | February 26, 2008 2:03 PM | 0 CommentsHouston, TX

  A recent study found that patients that received Bayer's Trasylol during heart surgery were significantly more likely to die within the next decade. Another study of 78,000 patients, originally withheld by Bayer, found a 78 percent increased risk of death within a week following the surgery. In November Bayer suspended sales of Trasylol after a Canadian trial linked the drug to higher death...

• Supreme Court Rules to Limit Medical Device Suits

  Scott Kappes | February 21, 2008 2:00 PM | 0 CommentsHouston, TX

  Yesterday the United States Supreme Court delivered a catastrophic blow to plaintiffs seeking to recover damages associated with FDA approved medical devices. The 8-1 decision bars attorneys from filing lawsuits against medical device makers in cases where the device received FDA approval before being introduced into the market. Most of the more complex and more risky devices such as heart...

• $7 Million Verdict Upheld in Accutane Lawsuit

  Scott Kappes | February 18, 2008 2:15 PM | 0 CommentsHouston, TX

  Drug giant Roche has been ordered to pay a $7 million verdict to man who had to have his colon removed after taking the popular acne medication Accutane. Allegedly the medication caused inflammatory bowel disease, Crohn's disease. This is the second loss for Roche in as many trials for Accutane. Roche still faces over 400 lawsuits alleging that Accutane caused Crohn's disease. An order handed...

• Heparin Investigation Uncovers Chinese Link

  Scott Kappes | February 15, 2008 12:50 PM | 0 CommentsHouston, TX

  A probe into the cause behind 350 bad reactions to the blood-thinner Heparin discovered that most of the active ingredient used in Heparin is produced at a Chinese facility. This information casts new doubt on the safety of the growing percentage of Chinese-based pharmaceutical plants. About 40 percent of the bad reactions were classified as serious, including four possible deaths. The cause of...

• Over 200 Injured by Icy Hot Patches

  Scott Kappes | February 13, 2008 4:50 PM | 0 CommentsHouston, TX

  This week Chattem Inc., the makers of Icy Hot, announced a voluntary recall of its Icy Hot Heat Therapy patches after over 200 complaints of burns and skin irritations were reported in conjunction with the use of the patches. Some consumers experienced first, second, and third degree burns from the product. It is not yet clear whether injuries resulted from the improper or proper use of the...

• Nationwide Recall Issued on Icy Hot Therapy

  Scott Kappes | February 12, 2008 2:47 PM | 0 CommentsHouston, TX

  Friday, in conjunction with the FDA, Chattem Inc. announced a voluntary recall of all sizes and lots of Icy Hot Air Activated Heat Therapy. The recall was prompted by reports of first, second, and third degree burns and skin irritation associated with the use or misuse of the product. More than 200 people claim to have been injured to varying degrees. Catherine Baker, a spokeswoman for Chattem,...

• GSK Profits Slip in Wake of Avandia Troubles

  Scott Kappes | February 11, 2008 3:11 PM | 0 CommentsHouston, TX

  Last week pharmaceutical giant, GlaxoSmithKline, announced that sales for 2007 slipped two percent from 2006. Much of the loss can be attributed to plummeting sales of the once blockbuster diabetes medication Avandia. In May a New England Journal of Medicine article linked the drug to a 42 percent increased risk of heart attack causing worldwide concern and in turn an almost instant plunge in...

• Chantix: FDA Issues Public Health Advisory

  Scott Kappes | February 01, 2008 4:20 PM | 0 CommentsHouston, TX

  Today the FDA issued a Public Health Advisory for Pfizer's stop smoking drug Chantix to inform health care providers and consumers about concerns surrounding the drug. Last November the agency issued an Early Communication on Chantix in response to an abundance of adverse events reported to the agency following the tragic shooting death of Dallas musician Carter Albrecht. Reports of behavioral...