The agency said the 80-milligram dose caused a potentially severe muscle disease, called myopathy, especially in the first year of taking the medication.
No new patients should be put on the high dosage, the F.D.A. said, recommending that existing patients should continue only if they have used the drug for more than a year without experiencing muscle pains. Alternative statins may be safer, the agency said.
This surely will lead to a spate of product/medical liability lawsuits against the manufacturers of this drug.
The drug’s manufacturer,
The F.D.A. approved 80-milligram Zocor in 1998, seven years after it approved lower dosages of the drug. It was once Merck’s top-selling product. Since the patent expired in 2006, simvastatin has mostly been sold as a generic drug.
The new restriction also applies to Vytorin, a combination drug sold by Merck and Schering-Plough that has some formulations in the 80-milligram dose.
And the restriction applies to Simcor, a combination pill sold by
Two other statins are more potent and can accomplish the same cholesterol targets at lower doses, he said, citing
Some doctors have prescribed simvastatin because it is cheaper in generic form. Lipitor goes off patent in November.
Muscle aches have long been known as a possible side effect of statins. The F.D.A. issued a safety warning on high-dose simvastatin in March 2010. On Wednesday, it said a seven-year study and patient reports prove that patients taking the higher dosage have a higher risk of muscle injury than those taking a lower dose of the drug or taking other statins.
The high doses accounted for 11.7 percent of 94 million simvastatin