Product Recall: Simvastatin (Zocor) - MedWaste Management Product Recall: Simvastatin (Zocor) - MedWaste Management

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Product Recall: Simvastatin (Zocor)

Simvastatin is a generic form of Zocor. Zocor  is a hypolipidemic, or anti-cholesterol, drug. It is a member of a class of drugs called statins. It’s made from the aspergillus terreus fungus and is used to reduce low-density lipoprotein (LDL) cholesterol. High LDL cholesterol levels (“bad” cholesterol) are associated with increased risk of stroke, heart attack, and cardiovascular death.

The World Health Organization (WHO) considered Zocor one of the safest, most effective, essential medications on the market. In 2005, Zocor earned its manufacturer, Merck, more than $4.3 billion in sales to an estimated 2.1 million patients.

Simvastatin Recall:

To date, there have been ten recalls of Simvastatin. The biggest Simvastatin recall so far affected just over 54,000 bottles, which is relatively minor compared to other generic medications. (Lisinopril had over a million bottles recalled at once.) The biggest recall was the  2015 Class III recall by Micro Labs, involving 54,096 bottles. The reason for the Simvastatin Recall was impurities in the pills.

FDA Warnings:

There is no complete Simvastatin Recall from the market.

However, due to FDA warnings, there are strict restrictions on the drug, especially the 80mg dose.

In 2011, the FDA announced changes for the safety labels of Simvastatin, because of increased risk of injury while taking the highest dose of 80 milligrams.

Risk of Injury is particularly high within the patient’s first 12 months of Zocor use at the 80mg dosage. The FDA advised that new patients should not be prescribed the 80mg dosage. Also, patients using 40mg doses of Zocor should not be increased to 80mgs. Instead, they should be switched to an alternative statin drug.

In 2012, the FDA issued a Drug Safety Communication warning users of interactions between protease inhibitors and statins. Findings indicated that using both simultaneously leads to increased risk of muscle injury. The safety labels of the HIV protease inhibitors as well as the affected statins have been updated to communicate the risk to patients.

All data came from the FDA’s Adverse Event Reporting System. This system is one of the main ways the FDA evaluates medicines after they have hit the market.

Simvastatin Side Effects:

Common side effects are headaches, constipation, and nausea. Simvastatin is contraindicated for patients with kidney trouble and pregnancy.

Other side effects include:

  • 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.
  • Muscle Pain

There have also been some findings on Simvastatin Weight Gain.

The weight gain may also be linked to sleep problems that can be set off by Simvastatin crossing into the brain. The resulting sleep disturbance can result in insulin resistance, weight gain, and generally affecting the patient’s quality of life in a negative way. 

The more severe side effects of Zocor occur in the muscles. Patients taking Zocor may develop myopathy, a condition that causes weakness and pain in the muscles. The muscle damage is often caused by the drug’s interaction with other medicines.

Some people are just genetically predisposed to this kind of muscle damage disease.

A risky, much less common side effect is Rhabdomyolysis, a fatal muscular disease. During rhabdomyolysis, the body’s muscles break down excessively and release myoglobin into the blood called myoglobin which can cause kidney damage. In severe cases, rhabdomyolysis can lead to kidney failure and death.

Patients taking Zocor who experience muscle pain or tenderness, fatigue, weakness, or dark urine should seek immediate medical attention.

Taking the 80mg dose of Simvastatin (the highest approved dose)have been found to be at greater risk for severe side effects, especially during the first year of treatment.

A European study shows that patients taking statins may have a nine-percent increased risk for developing type 2 diabetes and/or liver disease.

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

Merck Misconduct:

Merck has been accused of misconduct by failing to warn the public of the risks associated with using Zocor. Allegedly, Merck was negligent in its duties to its customers by not warning users of the severe side effects in time to prevent them. Merck is accused of purposely withholding knowledge about the risky side effects of Zocor.

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