Consumer Group Seeks Cholesterol Drug Ban
Source: Dr Koop.com

The consumer advocacy group Public Citizen is once again calling on the federal government to ban a newly marketed cholesterol-lowering drug because of what it calls dangerous side effects.

In a letter to the acting director of the U.S. Food and Drug Administration, Public Citizen said AstraZeneca's Crestor (rosuvastatin) could lead to a life-threatening muscle disease called rhabdomyolosis. Users are also at greater risk of kidney failure, the group said, citing FDA statistics.

In one case, a user developed rhabdomyolosis in the United States, where the drug had only been on the market for a little over five months, the Public Citizen letter said. Two other American users developed kidney failure within the same time frame, the letter added.

Six additional cases of the muscle disease and nine cases of kidney problems have been reported in the United Kingdom and Canada, where the drug has been available longer, according to the letter.

Noting an association between these side effects and higher-than-recommended doses, AstraZeneca recently issued a warning to doctors that the drug should not be prescribed at doses higher than 10 milligrams. Despite this, the letter from Dr. Sidney Wolfe, Public Citizen's health director, calls the medication "a doomed drug" that the FDA never should have approved in the first place, since the side effects had been observed in clinical trials prior to approval.