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.
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