Celebrex Newsroom

Crestor A Member Of A Class Of Cholesterol Lowering Drugs Commonly Referred To As Statins

Crestor, a member of a class of cholesterol-lowering drugs commonly referred to as “statins”, was approved in the U.S. in August 2003, based on review of an extensive clinical database involving approximately 12,000 patients.

These data supported the safety and efficacy of Crestor for use in lowering serum cholesterol, but also showed that Crestor, like all statins, rarely could cause serious muscle damage (myopathy and rhabdomyolysis).

In the approved labeling, the FDA identified in the WARNINGS section of the product label those patients in whom more careful monitoring was warranted when prescribed Crestor. In a section titled: “Myopathy/Rhabdomyolysis”, the label states that patients who are of advanced age ( 65 years), have hypothyroidism, and/or renal insufficiency should be considered to have a greater risk for developing myopathy while receiving a statin.

Physicians are warned to prescribe Crestor with caution in these patients, particularly at higher doses, as the risk of myopathy increases with higher drug levels.

Based on these concerns, from the time of original approval, the FDA required Astra-Zeneca to make available in the U.S. a 5-mg dose that could be used in patients requiring less aggressive cholesterol-lowering or who were taking concurrent cyclosporine. The maximum recommended dose in the FDA-approved label is limited to 10 mg daily in patients with severe renal impairment or who are also taking gemfibrozil.