The U.S. Food and Drug Administration last week advised doctors to use caution when prescribing Crestor, a cholesterol-lowering drug made by AstraZeneca.
The FDA Public Health Advisory follows a labeling change in the European Union for Crestor by AstraZeneca. The changes were prompted by recent reports of life-threatening side effects in some patients taking Crestor.
“The new European label address prescribing patterns in Europe by stressing the importance of using the medication appropriately, particularly in the small number of patients who require the highest dose (40 mg),” AstraZeneca said in a statement posted on its web site.
FDA is alerting prescribing doctors to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of muscle toxicity in individual patients.
Crestor is the most potent member of a class of cholesterol-lowering drugs commonly referred to as “statins.” Muscle toxicity is a recognized, side effect of statins, leading in rare cases to rhabdomyolysis, a muscle-destroying disease that causes kidney damage and other organ failure that are potentially life threatening.
FDA said it has received reports of rhabdomyolysis in association with Crestor, as it has with other drugs in the statin class.
“In ongoing fashion, we are evaluating these reports of adverse muscle effects with regard to clinical severity and apparent relationship to the drug,” FDA said in a statement. “FDA is comparing the frequency of reporting of muscle injury with Crestor to that with other statins, given differences in prescribing rates for the different drugs.”.
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