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FDA Warns of Zocor Dangers

By Paul Napoli

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare professionals that there is an increased risk of muscle injury associated with Zocor (simvastatin) 80 mg, a prescription drug used to lower

cholesterol, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

All statin drugs, including Zocor, which lower cholesterol by blocking the enzyme in the liver that manufactures cholesterol, have a known risk factor for a muscle injury called myopathy. Myopathy patients experience muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase).

Rhabdomyolysis, the most serious form of myopathy, occurs when release of the protein myoglobin causes muscle fibers to break down. In addition to the general myopathy muscle symptoms, patients with rhabdomyolysis experience dark or red urine and fatigue. Rhabdomyolysis can lead to kidney damage, failure and death because the myoglobin damages the kidneys as they filter the body's blood.

The FDA has issued this latest warning concerning higher doses of Zocor (simvastatin) and an increased risk of myopathy and rhabdomyolysis after reviewing data from a large clinical trial and data from other sources.

The FDA also found that after reviewing prescription drug use data, medical professionals are continuing to endanger patients by prescribing higher doses of simvastatin with other medications known to increase the risk for rhabdomyolysis, despite dose limitations and drug interaction precautions included in the simvastatin drug label.

Medical professionals should not prescribe simvastatin for patients taking Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, HIV protease inhibitors or Nefazodone. Patents using Gemfibrozil, Cyclosporine or Danazol should not be prescribed more that 10 mg of simvastatin. The maximum dosage for patients taking Amiodarone or Verapamil is 20 mg and for those taking Diltiazem, 40 mg.

The FDA encourages healthcare professionals to weigh the risks and benefits of simvastatin and carefully review patients' medications for potential drug-drug interactions before prescribing the drug.

The FDA says patients with questions about simvastatin should talk to their healthcare professional and continue using the drug unless told not to by their healthcare professional.

If you or a loved one has suffered harmful side effects or a dangerous drug interaction from over-the-counter or prescription medication, contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on March 22, 2010 (boomark / email).