The cholesterol-lowering “statin” drug Crestor (manufactured by AstraZeneca) has been the subject of controversy since it was first approved for sale in the United States in August 2003. While consumer groups like Public Citizen and medical experts (including FDA official and whistleblower, Dr. David Graham) have strongly urged that Crestor be either taken off the market or have its sales severely restricted, the FDA has resisted such extreme measures choosing instead to agree with AstraZenecaâ€™s claim that the drug poses no greater risks than those associated with other statins. Crestor, which was heavily promoted in Dr. Seuss-like rhymes read by the actor Patrick Stewart (now replaced by much more subdued advertisements), has already been the subject of two warning letters from the FDA with respect to misleading ads and a number of claims that it poses substantially greater dangers than other statin drugs like Zocor, Lipitor, and Pravachol.
Although there is a risk of rhabdomyolysis (severe muscle damage) with all statin drugs, critics maintain that Crestor is, by far, the most likely to cause this condition. Public Citizen maintains that its analysis of adverse events reported to the FDA between September 2003 and September 2004 linked Crestor to incidents of rhabdomyolysis at a rate 6.2 times higher than all other statin drugs combined. The FDA has acknowledged that Crestor does pose a greater risk to Asian patients as well as patients with severe kidney disease and those taking cyclosporine. As a result, a warning to that effect was added to the Crestor label in March of this year.
Now, however, a study published in the American Heart Association journal Circulation (online 5/23/05) claims that, as among the statins, even though the incidence of rhabdomyolysis is relatively low, “Crestor has a poorer safety profile.” Whether this will change the FDAâ€™s opinion as to the safety of the drug or cause it to require a more serious warning to be placed on the label remains to be seen.