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Zocor's risks at high doses may post an increased risk of muscle injury, the FDA reports. Patients on the highest dose of Zocor (simvastatin) seem to be at an elevated risk of this side effect, so doctors should stop prescribing that dose for most people, the FDA has advised.
An 80-milligram dose of Zocor (or similar drugs Vytorin and Simcor) should continue to be taken only by patients who have taken it for at least 12 months without muscle injury, the agency said Wednesday in a safety announcement.
Everyone else should heed the FDA’s updated labels on simvastatin, and simvastatin-containing drugs. The labels for Vytorin and Simcorthe will reflect the new dose-restriction recommendation. The labels for all three will offer more guidance about possible interaction risks when used with other drugs.
People take statins, which block an enzyme necessary for the cholesterol-making process, to lower “bad” cholesterol and decrease the risk of heart disease, the Los Angeles Times explains. Statins come in several brands and generics.
Many patients take an 80-milligram version of simvastatin—about 2.1 million people were prescribed a medication containing that dosage last year, the FDA said.
The FDA alerted consumers in March 2010 that this dosage may be dangerous after a clinical trial found that patients taking 80-milligram doses of Zocor were more likely to developmyopathy, a type of muscle pain or weakness, than those on the 20-milligram dose (0.9% of participants compared to 0.02%), the Times reports.
These Zocor risks, which apply equally for Vytorin and Simcor should be heeded by all patients.