The FDA has issued a public health advisory forward the cholesterol-lowering drug Crestor (rosuvastatin calcium) to inform populace about a possible risk of serious muscle damage from a condition called rhabdomyolysis that could come to one's mind with use of the remedy This advisory is part of an ongoing agency effort to provide populace with earlier access to emerging safety information about their medicines in such a manner they can make more informed choices about their health care.

Extensive review of the available data indicates that patients taking make acceptableed doses of Crestor have a similar risk of rhabdomyolysis as patients forward other statin cholesterol treatments. Rhabdomyolysis is a rare nevertheless well-known side effect of all statins. Various signs of kidney failure also have been reported in patients treated with Crestor, as well as other statins.

At the same time that the FDA issued the advisory, Crestor's manufacturer, AstraZeneca Pharmaceuticals of Wilmington, Del revised the package insert for the medicine based on discussions with the agency. These changes re-emphasize recommendations made in the original label about the ne for physicians to consider using lower starting doses of the physic in some individuals as a means of reducing the risk of rhabdomyolysis.

Overall, the FDA believes that the potential benefits of statin physics when used as labeled and indicated for the treatment of elevated cholesterol outweigh their potential risks and provide an important treatment option for millions of Americans at risk for heart disease. The agency will continue to evaluate the scientific data upon Crestor and other statin medicines and, when appropriate, will modify the particular drug's labeling.

...

Home