FDA issues warning label for AstraZeneca’s Crestor
The revised labeling urges doctors to start Asian patients, those with severe kidney disease and patients taking cyclosporine at the lowest dose level.
Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research said the advisory on Crestor "is part of an ongoing effort to notify the public of potentially significant emerging safety data so that they can make more informed choices about their medical care."
Consumer group Public Citizen has the FDA to ban Crestor, alleging the drug causes more dangerous side effects, including the rare-muscle disease rhabdomyolysis, than other statins.
But the FDA maintained a review of available data indicates the risk form Crestor is no greater than in other drugs in the class and concluded that all statins, when used properly, "outweigh their potential risks."
"Post marketing data for Crestor has been thoroughly reviewed over the past year and this labeling revision is the result of that analysis," AstraZeneca spokesman David Brennan said in a report on TheStreet.com. "The revisions that the FDA has approved provide physicians with further clarification on how to best use Crestor with their patients. We continue to believe that Crestor is safe and effective when used according to the prescribing information."