Is this a similar situation to what happened with Baycol® (cerivastatin), the cholesterol drug that was withdrawn from the market?

No. Baycol was associated with a high number of deaths due to rhabdomyolysis (more than 30). For this reason, the drug was withdrawn from the market. In contrast, there are no reported cases of death due to rhabdomyolysis with Crestor in the over 3 million patients worldwide who have used Crestor since launch.

The U.S. Consumer group Public Citizen has submitted a petition to the FDA recommending that Crestor be removed from the pharmaceutical marketplace. This comes after twenty-nine patients who had taken AstraZeneca Plc’s drug Crestor developed kidney damage. The rate of reported kidney problems is approximately 75 times higher than with competing drugs within the same class of statins.

Crestor (rosuvastatin calcium) is a cholesterol reducing drug and part of a class of pharmaceuticals called “statins.” Statins reduce cholesterol by reducing a specific enzyme responsible for the synthesis of Cholesterol in the body.

Statins have been associated with rare occurrences of Rhabdomyolysis, but significantly more occurrences have been reported that are associated with the use of Crestor. 65 cases of Rhabdomyolysis have been reported to the FDA so far, which is similar to the rate associated with Baycol.

The FDA Endrocrinologic and Metabolic Drugs Advisory Committee opposed the approval of Crestor because of its unique kidney toxicity. Because of the safety concerns, the maximum dose strength was reduced from 80 mg to 40 mg.

BAYCOL® is a registered trademark of Bayer Corporation.

CRESTOR® is a registered trademark of the AstraZeneca group of companies.

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