6-9- When the FDA announced that the popular cholesterol drug simvastatin, brand name Zocor, would need a new label warning, it simply reinforced something that many doctors already knew: The highest “recommended” dose of 80 milligrams a day is so dangerous that it probably shouldn’t be recommended at all.
Like other statin drugs, Zocor (generic name simvastatin), can cause muscle weakness and pain, which is annoying but not especially dangerous. But high doses of any statin can be toxic to muscles. In extreme cases, the muscles break down and release dangerous proteins that can damage the kidneys. This complication, known as rhabdomyolysis, can be fatal.
It’s not exactly news that Zocor, an older statin that was first approved by the FDA in 1991, seems to be riskier than other statins, especially at the high-end dose of 80 milligrams a day. The FDA itself warned about this danger in a “safety announcement” last year. At the time, the agency noted a study showing that about 1% patients taking 80 milligrams a day suffered from muscle damage. The same study included more than 6,000 patients taking 20 milligrams of Zocor a day; only one of them developed the muscle problem.
The FDA now says that doctors should no longer prescribe 80 milligrams of Zocor unless a patient has already been taking the dose for a year without any apparent trouble. But not everyone agrees that the warning goes far enough.
http://www.latimes.com/health/boostershots/la-heb-cholesterol-simvastatin-20110609,0,5240693.story?track=rss