The FDA released an 80 mg simvastatin (Zocor, Vytorin, Simcor) news release today, citing safety label changes for the highest dose of this widely used cholesterol-lowering medicine.
The FDA released an 80 mg simvastatin (Zocor, Vytorin) news release today, citing safety label changes for the highest dose of this widely used cholesterol-lowering medicine. Roughly 2.1 million prescriptions have been written for products containing this 80 mg dose and the changes made today are the result of FDA review of a 7 year study.
The highest approved dose of simvastatin has been associated with an increased risk of muscle injury (or myopathy)...especially during the first year of use. What the FDA is recommending is that the 80 mg dose should be used only in patients who have been taking this dose for 12 months or more and HAVE NOT had any muscle toxicity. They further added that this dose should NOT be prescribed to new patients. The FDA also revised the labels of combination products that contain simvastatin to caution against combinations with certain other medicines which may increase the blood levels of simvastatin (an undesirable drug-drug interaction).The FDA made its conclusions based on the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine.
It is important to note that such a pattern of increased risk HAS NOT been found with the 40 mg or lower doses. Patients with concerns should talk to their doctors BEFORE making any changes to their medicines. There is NO DOUBT that lowering of bad (LDLc) cholesterolis a key to decreasing risk of heart attack and stroke. The full FDA news release can be found at www.fda.gov.