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Simcard (simvastatin) is a cholesterol-lowering medication that has been linked to some severe side effects — especially when the drug is taken at high doses (80-mg) or used in combination with certain other medications (such as amiodarone). These side effects include myopathy and a life-threatening degenerative muscle disease called rhabdomyolysis, which can lead to kidney failure and death.

What is Simcard (simvastatin)?

Simcard (simvastatin) is a cholesterol-lowering medication manufactured by Cipla Pharmaceuticals Limited, India. It belongs to a popular class of medications known as “statins,” which block an enzyme the liver uses to create Low-Density Lipoprotein (LDL) cholesterol (“bad cholesterol”). Simcard reduces a patient’s risk of heart attack, stroke, and cardiovascular death.

Simcard and FDA Warnings

The U.S. Food and Drug Administration (FDA) has published several warnings about the increased risk of muscle diseases associated with all statins, including Simcard. Studies have found an increased risk of myopathy and rhabdomyolysis associated with statins. Higher doses are associated with higher risks.

In June 2011, the FDA published a Safety Communication, which recommended against using high-dose simvastatin (80-mg), and restricted the dose to 40-mg. The restricted dose of simvastatin is even lower when it is combined with certain other medications (such as amiodarone).

The FDA published another Safety Communication in December 2011 to restrict the dose of simvastatin to 20-mg when combined with amiodarone.

Simcard and Myopathy, Rhabdomyolysis

According to the FDA, patients taking simvastatin (the primary ingredient in Simcard) have a higher risk of myopathy and rhabdomyolysis compared to people taking lower doses or not taking the drug at all. This risk is highest when high doses are used for at least one year. The FDA estimates that hospitalizations for rhabdomyolysis occur in 4.9 people out of every 100,000 who take simvastatin for one year.

Myopathy is a mild muscle injury caused by breakdown of muscle fibers. Symptoms of myopathy typically include muscle pain, tenderness, or weakness, and elevated levels of a muscle enzyme called creatine kinase.

Rhabdomyolysis is a severe form of myopathy that occurs when muscle fibers are so damaged that they release a protein called myoglobin into the bloodstream. This protein can damage the kidneys. Damage to the kidneys can be so severe that patients develop kidney failure, which can be fatal. Symptoms of rhabdomyolysis are similar to myopathy, but may also include fatigue and dark-colored urine.

Simcard Side Effects

Some of the most serious Simcard side effects include:

  • Muscle disease
  • Myopathy (disease of muscle fiber)
  • Rhabdomyolysis (degenerative muscle disease)
  • Kidney damage
  • Kidney failure
  • Liver disease or failure
  • Type-2 diabetes
  • Death