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The FDA has announced that Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-American patients, as well as some other higher risk patients.

A clinical trial found that levels in Asian patients were double those of Caucasians taking the same dose, which can increase the chance of suffering serious muscle damage called rhabdomyolysis.

The consumer advocacy group Public Citizen has petitioned the FDA to ban Crestor from the market, and the group responded to the FDA’s announcement of revised labeling by saying it was “yet another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs.”

FDA whistleblower David Graham has also been critical of Crestor’s safety record, and Crestor manufacturer AstraZeneca halted Crestor ads in December after the FDA criticized them for being misleading by suggesting Crestor is safer than has been proved.

The new Crestor label re-emphasizes recommendations in the original label for physicians to consider starting patients on the lowest doses of the drug to reduce the risk of rhabdomyolysis. Revised labeling notes physicians should be especially aware of Asian American patients in lieu of the clinical trial data suggesting that they, along with patients on cyclosporine or patients with severe renal insufficiency, may have higher drug levels than the general population.

Crestor belongs to the category of drugs known as statins, which have been known to carry risk of the rare side effect rhabdomyolysis. Public Citizen noted that the rate of rhabdomyolysis in Crestor patients is not as high as it was for now withdrawn statin Baycol, but that Crestor has more reports of rhabdomyolysis than other available statins.