Simvastatin FDA Warning and Recall: The Story


Simvastatin. A statin-class drug used to decrease a person’s “low-density lipoprotein cholesterol,” or what we call bad cholesterol.

Simvastatin was approved in 1991 as a single-ingredient generic medicine. It was branded as Zocor. It comes in various dosages, with the 80mg dose prescribed to more than 2 million people.

The Food and Drug Administration (FDA), however, issued simvastatin warnings after a broad and wide-ranging review of information from clinical trials and data.

All data came from the FDA’s Adverse Event Reporting System. The system is one of the agency’s most important tools for tracking the safety of medicines after they have hit the market.

Simvastatin Muscle Pain

All statin drugs carry the risk of what’s called myopathy. In essence, this means weakness in the muscles.

However, those taking the 80mg dose of simvastatin, which is the highest approved medicinal dosage, have been found to be at greater risk of the disease. And this is especially true during the first year of treatment.

The muscle damage is often caused by the drug’s interaction with other medicines. Plus, some people are just genetically predisposed to this kind of muscle damage disease.

Even worse, a rare form of the disease, called rhabdomyolysis (rab-dough-my-all-iss-iss), can cause kidney failure and even death.

These findings caused the FDA to issue a recommendation: sharply limit the use of the 80mg simvastatin dose.

Note: there is no complete simvastatin recall from the market. But, the strict restrictions mean that no more patients will start on 80mg of simvastatin.

The only people allowed to continue using the 80mg dose are patients who have taken simvastatin for at least 12 months and have not shown any signs of ill effect or muscle toxicity.

Also, patients taking the 40mg dose who still fail to meet their cholesterol goal are not to be given the higher 80 mg dosage. Instead, they would be advised to choose a different statin drug completely.

Simvastatin Side Effects

Aside from myopathy and rhabdomyolysis, the drug can also cause several side effects, ranging from the relatively mild to the life threatening ones:

  • Muscle pain
  • Joint pain
  • Nausea
  • Dizziness
  • Constipation and other gastrointestinal problems
  • Liver damage brought about by increased liver enzymes. This is a serious side effect that must be addressed immediately.

There have also been some findings on simvastatin weight gain.

The root of this is sleep problems that can be set off by the drug crossing into the brain, unique to simvastatin. The resulting sleep disturbance can greatly affect the quality of a patient’s life and may have negative consequences, such as resistance to insulin and increase in weight.


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