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Zocor (simvastatin) is a popular cholesterol-lowering medication created by Merck & Co. Unfortunately, high-dose Zocor (80-mg) has been associated with an increased risk of rhabdomyolysis — a severe form of degenerative muscle disease (myopathy) that can lead to kidney damage, kidney failure, or even death.

What is Zocor?

Zocor (simvastatin) is a medication used together with diet and exercise to lower cholesterol. It specifically lowers the amount of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”) in the blood, which reduces a patient’s risk of heart attack, stroke, and cardiovascular death. Zocor belongs to a class of medications called statins, which lower cholesterol by blocking critical enzymes.

Zocor was developed by Merck, approved by the FDA in 1991, and it is now available as a generic medication.

Zocor and Rhabdomyolysis

One of the most serious side effects of high-dose Zocor is degenerative muscle disease called myopathy, which can lead to rhabdomyolysis in its most severe form. The FDA has warned that Zocor should be limited to 20-mg per day in patients who are also taking amiodarone, a drug for irregular heart rhythm.

Rhabdomyolysis is a disease that occurs when muscle fibers rapidly break down. The muscle fibers release protein (myoglobin) in the bloodstream, which can clog the filtering tissues in the kidneys. Rhabdomyolysis is the most serious form of myopathy (muscle injury), and it can lead to kidney failure and even death. The disease is rare, but it occurs in about 5 people per every 100,000 people who use Zocor for at least one year.

Symptoms of Rhabdomyolysis

Symptoms of rhabdomyolysis from Zocor include:

  • Muscle pain, tenderness
  • Muscle weakness, trouble moving arms or legs
  • Muscle cramps
  • Spasms
  • Stiffness
  • Elevated levels of a muscle enzyme in the blood (creatine kinase, CK)
  • Nausea, vomiting
  • Confusion
  • Fever
  • Dark-colored urine, reduced urine

FDA Warnings about Zocor Rhabdomyolysis

The U.S. Food and Drug Administration (FDA) has published several safety communications regarding the increased risk of myopathy and rhabdomyolysis associated with the use of Zocor, or Zocor in combination with other drugs.

  • In June 2011, FDA published a Safety Communication to limit the use of Zocor (simvastin) in 80-mg doses because of increased risk of muscle damage, myopathy, and rhabdomyolysis. They recommended that doctors should stop prescribing Zocor to new patients due to the risk of side effects.
  • In December 2011, FDA published a Safety Communication to warn that patients who are taking Zocor plus amiodarone should not exceed a 20-mg dose per day.
  • In March 2012, FDA published a Safety Communication to warn that combining Zocor with drugs for HIV or hepatitis C (anti-viral protease inhibitors) could increase the risk of myopathy and rhabdomyolysis.

Zocor Class Action Lawsuit

If you were injured by Zocor, you are not alone. A Zocor class action lawsuit has been filed in the U.S. District Court for the Eastern District of Louisiana. The plaintiffs allege that Merck failed to adequately warn about the risk of rhabdomyolysis, myopathy, and muscle injuries.

The lawsuit states, in part:

“The pharmaceutical drug, Zocor, is defective, dangerous to human health, unfit and unsuitable for be marketed and sold in commerce, and lacked proper warnings to the dangers associated with its use.”

Several other individual personal injury lawsuits have also been filed in federal court in Louisiana. The plaintiffs are seeking justice for their injuries, including compensation for medical expenses, pain and suffering, lost wages, and more.

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