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Simlup (simvastatin) is a medication that is used to control high cholesterol, a leading cause of heart attack, stroke, and cardiovascular disease. Unfortunately, taking high doses of Simlup for more than a year or using Simlup with certain other medications is associated with an increased risk of muscle toxicity, myopathy, rhabdomyolysis, kidney failure, and death.

What is Simlup (simvastatin)?

The drug Simlup (simvastatin) is a statin — a class of drugs that reduces cholesterol by inhibiting an enzyme called HMG CoA reductase. Simlup and other statins lower levels of “bad” cholesterol, also known as Low-Density Lipoprotein (LDL) cholesterol. People who have high LDL cholesterol levels are at risk of severe, life-threatening cardiovascular disorders.

FDA Warnings for Simlup

Simlup (simvastatin) and other statins are associated with an increased risk of muscle toxicity, and the risk increases with higher doses. According to the FDA, 4.9 people per 100,000 who take simvastatin are hospitalized for rhabdomyolysis, which can be fatal.

The FDA has issued the following warnings about simvastatin:

  • June 8, 2011 — Safety Communication After finding that high-dose (80-mg) simvastatin is associated with an increased risk of myopathy, FDA restricts the dose to 40-mg per day.
  • December 15, 2011 — Safety Communication The FDA restricts the recommended dose of simvastatin to 20-mg per day when the drug is combined with amiodarone (a medication prescribed for irregular heart rhythm)

Simlup and Myopathy, Rhabdomyolysis

Simlup is associated with an increased risk of muscle toxicity (especially when combined with amiodarone). In mild cases, patients may suffer from non-life-threatening myopathy, which involves the breakdown of muscle fibers. Myopathy typically causes muscle pain, weakness, and cramping. Patients who undergo blood tests have elevated creatine kinase enzyme levels.

In more serious cases, Simlup toxicity is associated with rhabdomyolysis — severe breakdown of muscle fibers, which releases the contents of the muscle fibers (a protein called myoglobin) into the bloodstream. Without treatment, the kidneys can be damaged, fail, and cause death.

Simlup Side Effects

People who suffer these symptoms while taking any statin, including Simlup, should seek emergency medical attention. They may be early signs of life-threatening muscle disease. Symptoms and side effects of Simlup include:

  • Muscle aches, soreness, cramps, or pain
  • Dark-colored urine
  • Fatigue
  • Myopathy
  • Rhabdomyolysis
  • Kidney damage, kidney failure
  • Liver injury
  • Type-2 diabetes
  • Death