FDA & Prescription Drugs

• 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...

• Researcher Leaked Avandia Report to Glaxo Before Publication

  Scott Kappes | January 31, 2008 11:34 AM | 0 CommentsHouston, TX

  A Texas researcher has admitted that he leaked a copy of the now infamous New England Journal of Medicine article that tied Avandia to an elevated heart risks. Steven Haffner of the University of Texas Health Science Center at San Antonio conceded that he faxed a pre-publication copy of the report to GlaxoSmithKline (GSK), the makers of Avandia, 17 days before the article was published. Haffner...

• Stop Smoking Aid Receives Approval in Japan

  Scott Kappes | January 29, 2008 10:03 AM | 0 CommentsHouston, TX

  Yesterday Pfizer announced that it had received approval from Japan's Ministry of Health, Labor, and Welfare to manufacture and market the popular stop smoking aid known as Chantix in the US. The drug will be marketed as Champix in Japan, as it is in the UK and EU. This will be the first oral smoking cessation aid availible in Japan and Pfizer expects it to be very popular among Japanese smokers...