After Baycol and Rezulin, Doctors Call For Reform
September 4, 2001
In light of the recent recall of the cholesterol lowering drug Baycol, medical professionals are calling for a better warning system to notify doctors of drugs' potential adverse side effects. Prior to the recall, the Food & Drug Administration (FDA) and Bayer, the maker of Baycol, sent letters to doctors warning them of the drug's tendency to cause rhabdomyolysis, a severe muscle disorder which can lead to kidney failure and death. Despite the warning letters, reports of Baycol related rhabdomyolysis continued, leading to the withdrawal of Baycol in August 2001.
Baycol had been on the market for nearly two years when reports of rhabdomyolysis began to surface. The FDA and Bayer warned physicians to slowly introduce Baycol to patients by initially prescribing low doses of the drug. In addition, officials suggested that doctors avoid prescribing Baycol to anyone already taking gemfibrozil, another cholesterol-lowering drug. Patients taking both drugs are more prone to develop muscle problems.
Public Citizen, a consumer advocacy group, recently petitioned the FDA to include warning labels on all cholesterol drugs, known as statins. While Baycol is linked to nearly ten times more rhabdomyolysis deaths, the other statins are also associated with the potentially fatal disorder.
Public Citizen's Health Research Group reports 81 deaths associated with Baycol. However, the group cautions that many more fatalities may go unreported because hospitals and doctors are not required to report adverse reactions to drugs.
Medical professionals are demanding a new, more effective warning system, citing both Baycol and the diabetes drug Rezulin as prime examples of the current system's failures.
After reports linking Rezulin to liver failure began surfacing in the late 1990s, the FDA and the drug's manufacturer sent four warning letters to physicians, informing them of the potentially fatal side effect. However, statistics indicate that doctors ignored the warnings. After at least 60 deaths from liver failure were associated with Rezulin, the drug was removed from the U.S. market in March 2000.
Physicians fear that deaths and serious illnesses associated with prescription drugs will continue to increase as medications become more innovative. Physicians receive the majority of their information on prescription drugs from pharmaceutical sales representatives, the Physician's Desk Reference and advertising. While advertising contains useful data and statistics, the Physician's Desk Reference is often out of date, leaving a huge gap in current information. Furthermore, pharmaceutical representatives are trying to make sales and may not provide independent, accurate information.
-- Article Courtesy of InjuryBoard.com
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