Zocor Shown to Cause Severe Muscle Damage
This past Wednesday, the Food and Drug Administration (FDA) released a revision of the prescribing information for the drug simvastatin, market name Zocor, which is prescribed to patients with high cholesterol.
The news comes after the FDA’s review of a seven year study on the drug. The FDA found that the drug, when prescribed at its highest dose of 80 milligrams (mg), put patients at a higher risk for severe muscle damage than patients who were prescribed the drug at a lower dose. Further, research has shown that out of 1,000 patients taking the 80mg dose of simvastatin, 61 experienced some form of muscle damage. In sharp contrast, out of 10,000 patients taking a 40mg dose of the same drug, only 8 experienced muscle damage.
Zocor is a statin, which lowers high levels of cholesterol. Just last year, Zocor was the second most prescribed drug in the United States, with 94 million prescriptions written, not including prescriptions for its generic form. (Source IMS Health, Inc.) Other drugs that contain simvastatin include Vytorin and Simcor.
Of the millions of patients taking Zocor, about 12 percent, or 1.2 million people, take the pill in its 80mg dose. The FDA is advising doctors not to prescribe the 80 mg dosage of simvastatin to patients who have never taken the drug before. Additionally, the FDA advises that the drug not be taken with certain other medicines, including antibiotics, anti-fungal medicines, and drugs to treat HIV.
Zocor is known to cause myopathy, a potentially serious form of muscle damage, and rhabdomyolysis, which is a breakdown of muscle fibers, causing a release of the fibers into the blood stream.
Every three out of four patients that take Zocor are protected from major cardiac events, but one out of every four patients suffers some form of muscle damage. Some doctors argue that this label change by the FDA is seven years too late.
If you or a loved one has taken Zocor, Vytorin, Simcor, or a generic form of these drugs and has experienced severe muscle damage, contact Van Wey Law today.
