The Food and Drug Administration has added new warnings to the blockbuster cholesterol drug Zocor, cautioning doctors that the highest dose of the drugs can cause muscle damage and potentially lethal kidney damage in rare cases.
Regulators say patients taking the 80-milligram dose of Zocor have a higher risk of muscle damage than patients taking lower doses of the drug or similar medications.
The 80-milligram dose should be continued only in patients who have been taking it for more than a year without signs of injury. The agency says new patients should start on a lower dose, the agency said in an online statement.
The FDA had issued word in March 2010 that it was looking into the issue.
Zocor is sold alone, as both a brand name and a generic. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor.
More than 2.1 million patients in the U.S. received a prescription for Zocor or a generic equivalent last year, according to the FDA.
Doctors say it is the most commonly used generic statin drug, and its use has been rising.
And other doctors noted that many patients were put on it when it became generic, because the price was lower.
