Originally approved in 1991, Zocor was given the nod for an 80-milligram version in 1998. Now, the FDA is saying that no new patients should be put on high-dose Zocor. What's more, the FDA is only comfortable with existing patients continuing with 80-mg Zocor if they have successfully used the drug for at least one year without experiencing muscle pain.
Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, noted in comments published Wednesday in The New York Times that the FDA move was long overdue. "Most experts in the field have known for many years that these high doses of Zocor were not safe compared with the other statins."
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This latest move by the FDA comes on the heels of a seven-year study that mirrored patient reports received by the FDA suggesting that patients taking the higher dose of simvastatin carried a higher risk for muscle injury than those taking lower doses of that particular statin, v. other statins.
The FDA, according to The New York Times, issued a safety warning on higher-dose simvastatin in March of last year. An estimated 2.1 million Americans use either Zocor or generic simvastatin.
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