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Bayer slow to pull Baycol from the market
-November 22, 2004
An editorial in the Journal of the American Medical Association is one of just several articles to appear in next week's edition that focuses on the FDA's ability to effectively monitor drug safety. Following the September Vioxx recall, more critics have been questioning the FDA's capability to adequately monitor drug safety considering its recent track record. The ability for drug companies to influence federal regulation has also come under intense scrutiny.
Now, additional information regarding the Baycol recall of August 2001 indicates Bayer AG may have known its cholesterol- lowering drug caused a high rate of rhabdomyolysis, a serious muscle condition, over a year before it added a warning to its label. Baycol was withdrawn from the U.S. market after it was linked to more than 100 deaths.
David Graham, a high profile FDA reviewer who accused the FDA of being incapable of protecting Americans from unsafe drugs one week ago in a Senate hearing, said in a separate article that three of the most popular cholesterol-lowering drugs pose a low risk of rhabdomyolysis, according to a study. The drugs include Pfizer Inc.'s Lipitor, Merck's Zocor and Bristol-Myers Squibb Co.'s Pravachol, which are in the same statin class as Baycol. The study found when the statins were taken with medicines that lower triglycerides, called fibrates, a 12-fold risk versus statinsFor more information on the Baycol recall, please contact us.
