Simvastatin (Generic Zocor®)

Simvastatin is a HMG-coA reductase inhibitor (statin), prescribed for patients with high cholesterol. It is sold under the brand name, Zocor®. Made by Merck, simvastatin was first approved for use in 1991. Since its approval, it has been prescribed in tablet form in the following strengths: 5 mg, 10 mg, 40 mg and 80 mg.

FDA Warning about 80 mg Dose

According to a warning put out by the U.S. Food and Drug Administration (FDA) in June 2011, patients taking 80-mg, the highest-approved dose of the cholesterol-lowering medication simvastatin, (Zocor®), may be at an increased risk of developing muscle side effects including myopathy and rhabdomyolysis, a potentially life-threatening condition.

The FDA warning recommends limiting use of the 80-mg dose because of its potential negative impact on a patient's health. The agency advised against prescribing this dose to new patients. The warning stated that patients taking this medication daily may be at an increased risk of myopathy compared to patients taking lower doses of simvastatin or other drugs in the same class.

According to reports, the risk appears to be higher during the first year of treatment and is often the result of interactions with certain medications. The risk is also frequently associated with a genetic predisposition toward simvastatin-related myopathy.

FDA Recommendations for 80 mg Dose

The FDA recommends that the 80 mg dose only be used by patients who have been taking the medication for 12 months and who have not experienced any adverse effects. In patients who are taking a lower dose of simvastatin and who are not meeting their LDL cholesterol goal, the FDA warning recommends that health professionals choose a different medication rather than raising the dose to 80 mg.

The FDA revised the drug labels for all simvastatin/Zocor® medications to include dosing recommendations when the drug is used in combination with medicines that increase the level of simvastatin in the body. It's important to note that the FDA does not want patients to stop taking their medication without consulting their doctors.

Simvastatin Warnings & Precautions

According to the warnings and precautions section of the drug's package:

  • Risks of skeletal muscle effects such as myopathy and rhabdomyolysis increase with higher doses of simvastatin
  • Patients should visit their doctor right away if they experience symptoms of myopathy
  • Patients have an increase in the risk of liver enzyme abnormalities

The most common types of adverse reactions include:

  • Upper respiratory infection
  • Headache
  • Constipation, nausea
  • Abdominal pain

Contact a Zocor® Attorney Today

If you were prescribed simvastatin and were diagnosed with myopathy or rhabdomyolysis, please contact one of our Zocor® attorneys. You may be eligible to file a claim to seek compensation.

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