FDA Issues Health Advisory on Crestor, OKs Updated Labeling

The FDA has issued a health advisory on AstraZeneca's Crestor, announcing that the cholesterol drug, like other statins, can have a rare side effect of serious muscle damage.

Clinical research has shown that patients taking statin drugs run the risk of developing a muscle disease known as rhabdomyolysis. The FDA stated that extensive review of the large amount of data available from controlled trials as well as the latest postmarketing safety information indicates that patients taking recommended doses of Crestor (rosuvastatin calcium) have a similar risk of rhabdomyolysis as patients on other statin cholesterol treatments.

In addition to issuing the public health advisory, the FDA announced it has approved revised labeling for Crestor. The changes re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis.

To view the FDA advisory, go to http://www.fda.gov/bbs/topics/news/2005/NEW01159.html (http://www.fda.gov/bbs/topics/news/2005/NEW01159.html).