FDA rejects petition to ban Crestor
Monday, March 14th 2005, 2:48 pm
News On 6
WASHINGTON (AP) _ The Food and Drug Administration said Monday it has rejected a petition to remove the cholesterol drug Crestor from the market.
Dr. Sidney M. Wolfe of the consumer group Public Citizen had petitioned the agency to remove the drug from sale, citing reports of muscle toxicity and kidney damage.
FDA said in its response that a review of several studies indicate that Crestor does not pose a greater risk of muscle damage than other cholesterol drugs, called statins, on the market.
In addition, Dr. Steven K. Galson of 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.