FDA Warns of Muscle Damage from Zocor

Last week, the Food and Drug Administration issued a new warning that high doses of Zocor, a popular cholesterol drug, and its generic forms, can cause serious and lethal muscle and kidney damage.

Zocor is manufactured by Merck, and its chemical name is simvastatin, which has been long studied by the FDA for its muscle injury side effects. The FDA is also evaluating data from a recent clinical trial that studied cardiovascular disease in patients prescribed high doses of 80 milligrams or more, versus those on 20 milligrams. The studies showed myopathy, or muscle damage, 52 to one in those taking the higher dosage. Also, eleven patients in the higher group developed rhabdomyolysis, or kidney failure, without any low-dose patients developing these conditions.

Rhabdomyolysis develops when extremely damaged muscle tissues release the protein myoglobin into the bloodstream. Myoglobin can damage the kidneys, leading to lethal kidney failure.

The FDA’s new warning addresses patients who may be taking simvastatin in combination with other medications, especially those on high doses.

If you or a loved one has suffered an injury related to Zocor, we would like to hear your story. Please contact the attorneys at Pogust, Braslow & Millrood