FDA issues warning label for AstraZeneca’s Crestor

Share this article:
AstraZeneca's cholesterol drug Crestor is being relabeled to add a warning telling doctors to start some patients at lower doses and to check for certain medical conditions before prescribing the drug.
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."
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.