80mg Dose of Zocor Now Comes With Strong Warning of Muscle Damage

With a long history of increased risk for Zocor muscle injury, the drug's label has recently been amended by the FDA. The FDA’s new recommendation was prompted by a seven-year study and patient reports that prove those taking the higher dosage of simvastatin have a greater risk of muscle injury and other Zocor side effects than patients treated with lower doses or other statins. The new restrictions and warnings also apply to Vytorin and Simcor, which are combination medications that include

simvastatin as an active ingredient. Generic versions of simvastatin will also include the myopathy warnings and be subject to dosing restrictions. The FDA estimates that 2.1 million people were prescribed some drug containing simvastin in 2010.

Until 2005, when generic versions became available, Zocor (simvastatin) was a top selling drug for Merck and remains popular today. On June 8, the FDA indicated that new warnings will be added to the label for choleterol-lowering medications containing simvastatin, indicating that 80 milligram dose has been associated with an increased risk of muscle injury or Zocor myopathy, especially during the first year of use. Doctors have been warned not to start new patients on 80 mg Zocor (simvastatin) prescriptions and to only use this highest dose among patients who have been taking 80mg Zocor for at least 12 months and have not experienced any muscle problems. The agency also added new contraindications and dose limitations when simvastatin is taken with certain other medications.

All statins have been found to carry a risk of myopathy, and rhabdomyolysis is the most severe form, potentially causing severe kidney damage, kidney failure and death. All statins currently contain a warning that myopathy and rhabdomyolysis are rare possible side effects. Zocor, though, is the first statin to carry a dose-specific risk label. Since the FDA warnings were issued in June, a number of Zocor lawyers are now evaluating potential lawsuits for individuals who developed muscle damage after taking 80 mg doses of simvastatin, arguing that the manufacturer has provided inadequate warnings about the potential risk. Anyone taking Zocor or another simvastatin product should contact their doctor immediately if they experience any of the symptoms of myopathy, regardless of dosage.