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March 18, 2005WSJ.com - FDA Rejects Petition to Ban Crestor From the Market
LINKThe Food and Drug Administration said Monday it has rejected a petition to remove the cholesterol drug Crestor from the market.
Sidney M. Wolfe, a doctor at the consumer group Public Citizen, had petitioned the agency to remove the drug from the market, citing reports of muscle toxicity and kidney damage. The drug is manufactured by AstraZeneca PLC. The FDA said in its response that a review of several studies indicate that Crestor doesn't pose a greater risk of muscle damage than other cholesterol drugs, known as statins, on the market. In addition, Steven K. Galson, of the FDA's Center for Drug Evaluation and Research, said the agency found no convincing evidence that the drug poses a risk of serious kidney injury. he agency said, because many patients who take these drugs have diabetes, high blood pressure or heart disease, they already may be at higher risk for kidney failure. Overall, the FDA said it believes the benefits of statin drugs, when used as recommended, outweigh their potential risks. |