US call for ban on cholestrol drug

A 39-year-old woman has died of a muscle-destroying condition linked to the controversial new anti-cholesterol drug Crestor, a consumer advocate claimed in Washington today, citing 16 cases of serious side effects in urging a ban of the drug.

Crestor is in the popular family of cholesterol-lowering drugs called statins.

It won US Food and Drug Administration approval in August, after a delay because of safety concerns.

In studies, Crestor also was linked to some cases of kidney abnormalities not seen with other statins.

The FDA decided to approve Crestor, saying it appeared to be slightly more potent than other statins and thus may be important for some patients.

To lower the risk of side effects, FDA recommended starting doses of 5 mg to 10 mg, and said patients should never exceed 40 mg.

But records from the FDA and health agencies in Canada and Britain show life-threatening side effects occur even at those lower doses, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, in a petition filed with FDA Thursday seeking a ban.

Crestor maker AstraZeneca would not comment on the deaths or other serious side effects except to say “the safety profile is totally comparable” to what pre-marketing studies had predicted, said spokesman Gary Bruell.

The FDA will evaluate the petition, said spokeswoman Laura Bradbard.