Simcard (simvastatin) is a type of cholesterol-lowering medication called a statin. Unfortunately, Simcard has been associated with some life-threatening complications, including muscle disease (myopathy) and rhabdomyolysis, a severe break-down of muscle fibers that can cause kidney failure and death. These risks are greatest when Simcard is taken at high doses (80-mg) for at least one year, or used with certain other medications.
What is Simcard (simvastatin)?
Simcard (simvastatin) is a medication that is used to lower cholesterol. It is manufactured by Cipla Pharmaceuticals Limited, India. Simcard is a statin, which is a type of medication that inhibits an enzyme the liver uses to create Low-Density Lipoprotein (LDL) cholesterol, or “bad” cholesterol. High levels of LDL cholesterol increase a person’s risk of cardiovascular diseases, including heart attack and stroke.
Simcard and FDA Warnings
In response to many studies linking simvastatin to serious side effects, the U.S. Food and Drug Administration (FDA) has published multiple warnings. Simcard is associated with an increased risk of myopathy and rhabdomyolysis, especially when a patient uses high doses of Simcard (80-mg) for more than one year. Higher doses of Simcard are associated with higher risks of muscle diseases.
- The FDA published this Safety Communication on June 8, 2011. They restricted the recommended dose of simvastatin to 40-mg per day because of increased risk of muscle damage.
- In December 2011, the FDA published another Safety Communication. They limited the recommended dose of simvastatin to 20-mg per day when it is combined with amiodarone (a drug used to control irregular heart rhythm).
Simcard and Myopathy, Rhabdomyolysis
Simcard (simvastatin) is associated with muscle disease, myopathy, and rhabdomyolysis. According to the FDA, hospitalizations for rhabdomyolysis occur in about 4.9 people per 100,000 who use the medication for at least a year. The risk increases for people who use high doses.
Myopathy is a degenerative muscle disease in which muscle fibers break down. Symptoms include muscle pain, weakness, tenderness, and elevated creatine kinase enzymes in the bloodstream.
Myopathy is not life-threatening, but severe cases can lead to rhabdomyolysis, which is a life-threatening muscle disease. Rhabdomyolysis occurs when damaged muscle fibers release protein into the bloodstream. This can cause kidney damage, kidney failure, or even death. Symptoms are similar to myopathy, but also include dark-colored urine and fatigue.
Simcard Side Effects
Simcard is associated with some severe, life-threatening side effects, which include:
- Muscle injury
- Kidney damage
- Kidney failure
- Liver disease, liver failure
- Type-2 diabetes
- And more