Quoted from http://www.reuters.com/article/2011/06/08/fda-merck-idUSL3E7H835S20110608
FDA recommends limits on highest dose of Merck's Zocor
Wed Jun 8, 2011 3:44pm EDT
By Esha Dey
BANGALORE, June 8 (Reuters) - U.S. health regulators recommended limiting the use of the highest dose of Merck & Co's cholesterol drug Zocor, citing an increased risk of muscle damage.
Zocor, also known as simvastatin, is widely available as a generic drug and is also sold in combination with ezetimibe as Merck's Vytorin and niacin as Abbott's Simcor.
The highest approved dose of 80 mg should be used only by patients who have been taking it for 12 months or more without any evidence of muscle injury, the U.S. Food and Drug Administration said on its website.
"We do not see much impact here given the fact that relatively few patients were being started at this high dose," Merck Chief Medical Officer Michael Rosenblatt said.
"Most doctors were already aware that there was a disproportionate number of muscle side effects at this dose. And most of it is generic any way for simvastatin," he added.
The FDA also requires changes to the drug label to add new contraindications and dose limitations for using the drug with certain medicines.
Patients taking Zocor 80 mg daily have an increased risk of muscle injury compared to patients taking lower doses of the drug or other drugs in the same class, the FDA said.
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