March 20, 2010

FDA Issues Public Safety Announcement on Popular Cholesterol Medication Zocor

Zocor (simvastatin) is a prescription medication that has been used by millions of Americans to help lower high cholesterol and prevent cardiovascular disease.  On March 19, 2010, the FDA released a public Safety Announcement regarding increased safety risks for patients who take the 80 milligram dose of Zocor (the highest approved dosage of the medication).  An analysis of a large clinical trial (SEARCH) and other data revealed that patients taking Zocor 80 mg. had an increased risk of developing a serious and painful muscle wasting condition called rhabdomyolysis compared to patients taking lower doses of Zocor and possibly other drugs in the statin drug class. 

This class of drugs has come into question in more recent years following the 2001 recall of Baycol, another popular cholesterol-lowering medication in the statin drug family.  Muscle pain, or myopathy, is a known side effect with all statin medications, but the risk of developing myopathy is increased when Zocor is taken at the 80 mg dose, as well as if this medication is combined with other drugs. The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal.

Click here to read the FDA Safety Announcement

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