Tuesday, January 10, 2012

Generic Zocor Leads to Woman’s Muscle Breakdown


An Ohio woman has filed a Zocor lawsuit against Merck, alleging that the side effects of Zocor caused her to suffer rhabdomyolysis and other kidney problems after she took an 80 mg dose of the popular cholesterol drug. The FDA has issued a warning against the 80mg dosage of Zocor. The warning was issued because of Zocor's association with an increased risk of muscle injury. Zocor, known in its generic form as simvastin, is a cholesterol lowering drug. While statins in general tend be associated with a higher incidence of muscle injury, Zocor may leave patients susceptible to an even higher risk of muscle injury including rhabdomyolysis. Rhabdomyolysis is a critical form of muscle injury, which has the potential to cause serious kidney damage, kidney failure, and even fatality.
Hayden’s is the first lawsuit to be filed against the makers of Zocor or a generic version of the drug, simvastatin, since the Food and Drug Administration warned earlier this year that taking Zocor or simvastatin at 80mg daily doses, either all at once or via two, 40mg doses per day could lead to rhabdomyolysis or myopathy. Regulators went so far as to restrict access to that dosage levels because the risk was so high. The report indicates the lawsuit filed by the Ohio woman accuses Merck of “negligence, strict liability, failure to warn, breach of warranty, misrepresentation and suppression, fraud, negligent misrepresentation and violating consumer protection laws.” She seeks monetary and punitive damages, including the medical costs associated with treating her new condition.
In June of last year, Merck announced that the prescribing information for Zocor would change to reflect the recent findings of an increased risk of myopathy, including rhabdomyolysis. The new prescribing information also recommends that patients currently using simvastatin 80 mg who need to be initiated on a drug with a contraindication or dose cap be switched to an alternative statin with less potential for drug interaction. The lawsuit charges Merck with negligence, strict liability, failure to warn, breach of warranty, misrepresentation and suppression, fraud, negligent misrepresentation and violating consumer protection laws. Hayden seeks compensatory and punitive damages against the drug maker.

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