Public Citizen Asks FDA for Stronger Warning on Statin Drugs
Almost two weeks after Bayer AG pulled its cholesterol drug Baycol from the market because of safety concerns, the consumer group Public Citizen is asking the FDA to require "stronger warnings" on other drugs in the statin class, the Wall Street Journal reports. Besides Baycol, Public Citizen has "singled out" Lipitor by Pfizer Inc., Zocor and Mevacor by Merck & Co., Pravachol by Bristol-Myers Squibb Co. and Lescol by Novartis AG. Statins, one of the drug industry's "most important" and "widely used" products, are associated with risk of rhabdomyolysis, a "debilitating muscle-weakening condition" that can be fatal (Adams, Wall Street Journal, 8/21). Baycol was linked to 31 deaths from rhabdomyolysis over a three-year period (ABCNews.com, 8/20). Use of statins is expected to "skyrocket" in coming years because recent federal guidelines called for "far more people to begin taking them" to lower their cholesterol, the Journal reports. Based on FDA records, Public Citizen cited 772 cases of rhabdomyolysis among patients taking the six drugs between October 1997 and December 2000. Half of those cases were related to use of Baycol, and each of the five other statins were linked to between 10 and 187 cases (Wall Street Journal, 8/21). Sidney Wolfe, director of the organization's Health Research Group, said, "Doctors and patients are grossly uninformed about this" (Sternberg, USA Today, 8/21). He added, "Baycol is more dangerous than these other drugs. But these other drugs are more dangerous than most doctors and patients realize" (ABCNews.com, 8/20). Public Citizen is asking the FDA to require its "most severe warning" -- called a "black box" -- for statin labels, as well as an FDA-approved guide for patients and a "dear doctor" letter for physicians nationwide. John Jenkins, a drug-review official with the FDA, said that the agency believes the number of "serious reports" and deaths associated with statins is "much lower" than the numbers Public Citizen reported, but he added that the agency is taking the group's petition "very seriously" (Wall Street Journal, 8/21). If the FDA requires the black box warning, it decreases the likelihood that the drugs would ever be available over the counter, the Washington Post reports. Last year, Merck and Bristol-Myers both applied for OTC status for their drugs but were turned down (Brown, Washington Post, 8/21).