:: Health News ::

FDA recently provided health care practitioners and patients with updated information about the risks and benefits of Crestor (rosuvastatin calcium), a cholesterol-lowering drug made by Astra-Zeneca Pharmaceuticals.

Crestor, like all other statins, has been associated with rhabdomyolysis. The incidence of this effect is low, and the risk of serious muscle damage doesn’t appear to be greater for Crestor than for other statins.

But as with all statins, the risk of myopathy increases with higher drug levels. So Crestor’s labeling has been changed to re-emphasize the risk of myopathy, particularly at the highest approved dose of 40 mg. The labeling also stresses the need to consider using lower starting doses in some patients.

This may be particularly important when treating Asian Americans, since a large pharmacokinetic study found that this group of patients had drug levels about twice as high as a Caucasian control group, and that could increase their risk for myopathy. The revised labeling now recommends that the 5 mg dose of Crestor be considered as the starting dose for Asian-Americans, and also for others with predisposing factors for myopathy, including patients on cyclosporine and those with severe renal insufficiency.

Additional Information:

FDA MedWatch Safety Alert 2005 - Crestor (rosuvastatin calcium)
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#crestor