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.

Consumer Watch Group Calls For Ban of Zocor

Zocor (simvastatin) is a synthetic statin developed by Merck that is designed to lower cholesterol. Zocor is part of a class of drugs called statins that are used to treat high LDL (bad) cholesterol. Simvastatin is also sold in generic versions, and is an active ingredient in the combination drugs Vytorin and Simcor. Zocor muscle injury has long been recognized as a possible statin side effect, and the labels of these medications all bear warnings regarding this risk. In 2010, the U.S. Food and Drug Administration (FDA) updated the labels of high-dose simvastatin to warn of an association with muscle injuries.

The FDA now says that doctors should no longer prescribe 80 milligrams of Zocor unless a patient has already been taking the dose for a year without any apparent trouble. But not everyone agrees that the warning goes far enough. Public Citizen has placed the Zocor 80 mg doses on its “Do Not Use” list, following an FDA warning about the risk of serious and potentially life-threatening muscle damage from Zocor that

Zocor Side-Effects Have Been Linked To Max Dosage

The FDA has revised the drug labels for Zocor, generic simvastatin pills, to include the new 80 mg dosing restrictions. According to the FDA, there is a higher risk of developing rhabdomyolysis (sometimes just called "rhabdo") with the 80 mg dose of Zocor or simvastatin in two instances: during the first year using pill with 80 mg, and when a Zocor 80 mg or generic simvastatin pill which contains 80 mg dose of simvastatin is used in combination with patients taking calcium channel blockers, particularly Cardizem or generic Diltiazem. The FDA also indicated that the 80mg Zocor dose has the highest rate of many different types of muscle injury of any statin and recommended that it only be used by patients who had already taken 80 mg of simvastatin for at least a year without problems.
Zocor is a synthetic statin developed by Merck & Co., which is also widely available as generic simvastatin. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best-selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005. Currently, potential product liability lawsuits are being reviewed by lawyers for individuals throughout the United States who have been diagnosed with rhabdomyolysis, myopathy or severe Zocor related muscle problems. The side-effects are usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.
Of the 253 million prescriptions written for cholesterol-lowering drugs in 2010, some 11 million were prescribed at the 80mg dosage. Given the recent FDA warning, Merck may soon be defending numerous Zocor lawsuits.  Additionally, the FDA has also required Merck to change the drug’s labeling in order to reduce the risk of prescription errors, and clearly differentiate the drug’s differing dosage amounts.  As a result of Merck’s failure to warn consumers about the risk of muscle injuries and potential for kidney failure, the likelihood that those individuals will begin filing Zocor lawsuits increases.  Should Merck be found liable in these Zocor lawsuits, the company will have to pay compensation to injured victims.