Zocor (Simvastatin) is a prescription medication that lowers blood cholesterol levels by blocking the production of cholesterol in the body. Manufactured by the pharmaceutical company Merck & Co., Zocor is a member of a class of drugs known as statins that inhibit the enzyme responsible for cholesterol synthesis. Zocor is normally prescribed if one’s blood cholesterol levels are too high, but only after non-drug treatments such as a low-calorie diet and exercise have proven unsuccessful. Once administered, Zocor is meant to be a supplement to other cholesterol-lowering measures. Maintaining a normal cholesterol level is important because it may lower the risk of heart disease and stroke.
Zocor FDA Warning
On March 19, 2010, the U.S. Food and Drug Administration (FDA) issued a safety announcement regarding Zocor use. The Zocor FDA Warning stated that according to data from a large clinical trial, as well as data from other sources, there may be an increased risk of muscle injury in consumers who are taking the highest approved dose of Zocor, 80 mg, compared with those who take lower doses of Zocor, or its generic Simvastatin.
The increased risk of muscle weakness may also be associated with other statin class drugs. An 80 mg dosage has been shown to have a higher risk of skeletal muscle injury, particularly in cases where the drug is combined with other medications. Simvastatin is also part of Merck’s cholesterol drug Vytorin and Abbott Laboratories’ drug Simcor. The drug is currently sold by 11 other generic drug makers.
Zocor Side Effects
The muscle weakness associated with high doses of Zocor is known as myopathy. Symptoms of myopathy include:
- Muscle pain
- Muscle weakness, or weakness in the limbs
- Elevated muscle enzymes in the blood
- Muscle cramps or stiffness
Statins such as Zocor may result in a very serious form of myopathy knows as rhabdomyolysis. In fact, a once popular statin known as Baycol (Cerivastatin) was withdrawn from the market in 2001 after numerous reported cases of rhabdomyolysis. Rhabdomyolysis, or “rhabdo” for short, occurs when the skeletal muscle breakdown is rapid.
This breakdown results in the release of muscle fibers (myoglobin) into the bloodstream. When the myoglobin compounds are broken down and released into the bloodstream, they are eventually filtered through the kidneys. Some of these compounds are very harmful to the kidneys and have been known to cause kidney damage and in some cases kidney failure. Symptoms of rhabdomyolysis may include:
- Muscle tenderness
- Muscle stiffness or aching
- Abnormally dark or red colored urine
- Joint pain
- Unintentional weight gain
When statins are combined with other medications, especially other hypolipidemic agents such as fibrates, the risk of developing rhabdomyolysis may increase.
If you or someone close to you has experienced any potential side effects from using Zocor, you may be entitled to compensation from the manufacturer. For a free consultation and review of your case, call us at 1-888-316-2311 or email us.