80mg Zocor Linked to Liver Damage In FDA Warning

Statin drugs have been linked to diabetes and muscle injury in many recent studies. European researchers report that high-dose regimens of a class of drugs known as statins, such as Zocor may be linked to the onset of diabetes in rare cases, although the drugs do lower the risk of cardiovascular disease. The results of the study were published online in June by the Journal of the American Medical Association. Zocor has also been linked to muscle injury and Zocor liver damage. The researchers looked at five studies involving a total of 32,752 subjects. All were given statin-based cholesterol drugs, but half were given high doses of about 80 mg per day and the other half were given lower doses of 20 to 40 mg per day for an average of about five years. They found that more participants given high doses developed diabetes than those who were given lower doses.  Patients taking 80mg dose Zocor are more likey to experience myopothy, or Zocor rhabdomyolysis as well.

Zocor 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury, the FDA said. The FDA also said health care professionals should switch such patients to another statin if they find that taking 40 mg of simvastatin isn’t meeting their LDL cholesterol goal, rather than raising the simvastatin dose to 80 mg. According to a report from The New York Times, this latest action on the part of the FDA was prompted by a seven-year study and patient reports that prove those taking the higher dosage have a greater risk of Zocor muscle injury than patients treated with lower doses or other statins. Generic versions of simvastatin will also include the myopathy warnings and be subject to dosing restrictions.

Rhabdomyolysis from Zocor causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism. The FDA estimates that 2.1 million people were prescribed some drug containing an 80 mg dose simvastatin in 2010.