The FDA did not go far enough in restricting the use of high doses of the cholesterol drug Zocor, and approval for 80 mg simvastatin medications should have been withdrawn according to Public Citizen, a prominent consumer group.
Public Citizen has placed the Zocor 80 mg doses on its “Do Not Use” list, following an FDA warning about the risk of serious and potentially life-threatening muscle damage from Zocor that was issued earlier this week.
The FDA announced June 8 that it is recommending that no new patients be started on an 80 mg Zocor (simvastatin) regimen, due to the risk of myopathy, rhabdomyolysis, kidney damage and other muscle injury.
However, instead of issuing a Zocor recall for the 80 mg dose, the FDA allowed doctors to continue prescribe the medication to patients at the highest dose as long as they had taken it for at least a year without ill effects.
Public Citizen has indicated that the FDA did not go far enough and should have issued an outright ban on the high dose version of Zocor, according to a statement made in it’s Worst Pills, Best Pills newsletter. The consumer group has designed Zocor 80mg as a “Do Not Use” medication, and urged all consumers, including those who had taken Zocor 80 mg without any problem so far, to consider switching to another medication or lower Zocor dosage. However, the organization cautioned that patients should check with their doctors before ending any drug treatment.
Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is also widely available as generic simvastatin. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.
Rhabdomyolysis from Zocor causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.
Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. Statin is used in a number of other popular cholesterol controlling drugs, including Crestor, Lipitor, Mevacor, Lescol and Pravachol.
All statins have been found to carry a risk of myopathy, and rhabdomyolysis is the most severe form, potentially causing severe kidney damage, kidney failure and death. All statins currently contain a warning that myopathy and rhabdomyolysis are rare possible side effects.
Since the FDA warnings were issued this week, a number of Zocor lawyers are now evaluating potential lawsuits for individuals who developed muscle damage after taking 80 mg doses of simvastatin, arguing that the manufacturer has provided inadequate warnings about the potential risk.