The U.S. Food and Drug Administration (FDA), today issued public health advice, patient information, and professional healthcare information on the risks and benefits of Crestor (Rosuvastatin calcium), a cholesterol-lowering drug.
Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER) said the advice is in line with the FDA's committment to providing Americans with the latest and most comprehensive information on the medicines they use; it 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.
FDA's up-to-date information about the risk of rhabdomyolysis (serious muscle damage) in patients taking Crestor and other statin drugs is welcome. The rare adverse effect of statins is well-known and has been extensively documented and reviewed.
As a result of discussions with the FDA., Crestor's manufacturer Astra-Zeneca Pharmaceuticals revised the package insert for Crestor; recommendations made originally about the need for physicians to consider using lower starting doses of the drug in some individuals to reduce the risk of rhabdomyolysis have been re-emphasised.
This is particularly important in treating Asian American patients, since trial data suggests that they may be at greater risk of muscle injury due to Crestor (along with patients on cyclosporine or patients with severe renal insufficiency) as they may have higher drug levels.