Zocor and Rhabdomyolysis
In June 2011, the FDA issued a new warning that high doses of Zocor, a popular cholesterol drug can cause serious and lethal muscle and kidney damage. FDA Warning.
According to the FDA, the highest approved dose, 80mg, has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use. It has been recommended that Zocor 80 mg only be used in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients at this dose.
Zocor is prescribed in order to reduce the amount of bad cholesterol in the blood. In 2010, approximately 2.1 million patients in the United States were prescribed a product containing simvastatin 80 mg, the main ingredient in Zocor.
The changes to the label for simvastatin-containing medications are based on the FDA’s review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA’s Adverse Event Reporting System. All showed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury.
Zocor is manufactured by Merck, and has been long studied by the FDA for its muscle injury side effects. Rhabdomyolysis develops when extremely damaged muscle tissues release the protein myoglobin into the bloodstream. Myoglobin can damage the kidneys, leading to lethal kidney failure.
If you or a loved one has suffered rhabdomyolysis while taking high-dose Zocor, we would like to hear your story. Please contact the attorneys at Pogust, Braslow & Millrood.