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FDA limits 2nd most prescribed drug: cholesterol lowering Zocor

Dominika Osmolska Psy.D.'s picture

The cholesterol-lowering drug simvastatin, known by its brand name Zocor, has been implicated in muscle injury and damage. The FDA is changing safety labeling for the second most-prescribed drug in the country after a seven year clinical trial has demonstrated that it can result in severe cases of myopathy in vulnerable patients. Myopathy refers to any disease that affects muscle tissue. Diseases of the muscle result in weakness, inflammation, tetany (spasms), or paralysis.

Zocor's higher doses implicated

The FDA’s new warnings are specifically for the highest dose – 80 milligrams – at which some patients have even developed a rare condition called rhabdomyolysis, in which muscle fibers break down and release a kidney-damaging protein into the bloodstream.

The FDA recommends that no new patients be prescribed Zocor at its highest dose, and that anyone who has been taking it at that dose for under a year should discontinue. The warnings also apply to two other drugs containing simvastatin in combination with other medications – Vytorin and Simcor.

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It should be noted that the increased risks of myopathy are still very small - 0.9% for the 20 milligram dose compared to 0.02% for the 80 milligram dose). The risk for rhabdomyolysis was a minuscule 0.4%. Given these statistics, the decision to stop or reduce the medication should be weighed against the risks associated with unhealthy levels of cholesterol, in particular LDL, the “bad” type of cholesterol.

As the second most-prescribed medication in the US, Zocor has been an invaluable ally in fighting heart disease, stroke and inflammatory conditions for 20 years. The statin family of drugs, of which Zocor is a part, has also been tentatively demonstrated to help lower the incidence of dementia and memory loss in elderly patients. Since unprecedented numbers of people are suffering from elevated cholesterol and coronary artery disease with which it is associated, the statins have arguably been the drug superstars of the last two decades. For years, everyone has been asking, where is the downside to taking them? It appears it has emerged in today’s announcement.

The FDA recommends that if patients have other options to choose from, they should go ahead and take them rather than risk their health in either continuing to take the high dose, or quitting the drug altogether. It should be noted that all statins carry a small risk of muscle damage, but only Zocor has thus far been implicated in the more severe cases.

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