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August 2011, Volume 41 Number 8 , p 16 - 16



Because of increased risk of myopathy, the FDA is recommending that healthcare providers restrict the use of the highest-approved dose (80 mg) of the HMG-CoA reductase inhibitor simvastatin. The new recommendations call for lower starting dosages in new patients; the 80-mg dose should be given only to patients who've been taking the high dose for 1 year or more without any evidence of myopathy.The changes are the result of the FDA's review of a 7-year study that compared the efficacy and safety of 80 and 20 mg simvastatin dosages, with or without vitamin B12 and folate, in patients who'd had a myocardial infarction. Fifty-two patients (0.9%) taking 80 mg developed myopathy, which was higher than the labeled risk of 0.53%. The risks for myopathy in patients taking 80 mg were highest in the first year of treatment.The FDA is also requiring changes to the drug label that add new contraindications and dose limitations for simvastatin when used with other medications.Source: FDA drug safety

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