Washington, DCThirteen years after high-dose Zocor was approved by the US Food and Drug Administration (FDA) as a drug whose benefits outweighed its risks, the health regulator has slapped new restrictions on the drug over concern for the onset of myopathy.
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."
Zocor is the brand name for simvastatin, a drug designed to help patients maintain optimum cholesterol levels. The patent, originally held by Merck, expired in 2006, and Zocor has been sold mostly in generic form ever since. The restrictions apply to generic Zocor as well, together with Vytorin (a joint project of Merck and Schering Plough) and Simcor, manufactured by Abbott Laboratories.
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.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your claim at no cost or obligation.