Warnings Prompted by Reports of Rhabdomyolysis Side Effects

Product information for Crestor (rosuvastatin) has been changed after European regulators required AstraZeneca to recommend a low initial dose and restrict indications for the highest dose of the cholesterol-lowering drug. The product information will now require patients to be started on an initial dose of 10 mg and only increased after a 4 week trial. The 40 mg dose should be prescribed only under specialist supervision and should not be prescribed to people who have specific risk factors for myopathy. These recommendations about safe use of Crestor were set forth in a new Dear Doctor letter to European doctors. This action follows an earlier Dear Doctor letter to British health care professionals from AstraZeneca in May 2004, which cautioned physicians against prescribing higher initial doses. These letters heighten concerns about the safety profile of Crestor.

Crestor, the newest addition to the statin class of cholesterol-lowering drugs, has been under fire because it is more potent than other statins on the market; AstraZeneca has marketed it as a "super statin." Baycol, which was removed from the market in 2001 after reports of rhabdomyolysis and death, was also a super statin. Rhabdomyolysis is a recognized, dose-related adverse reaction to drugs in the statin class, particularly when taken with a fibrate such as Lopid (gemfibrozil). Rhabdomyolysis is severe myopathy (muscle toxicity) leading to kidney damage.

Read more about Crestor on our Crestor Information Page