Group wants tougher warning on statins

WASHINGTON (CNN) -- A consumer advocacy group is pushing for a special warning label to be added to cholesterol-lowering medications called statin drugs.

Public Citizen is petitioning the U.S. Food and Drug Administration to require statin drug makers to warn patients about of the risk of muscle deterioration when unexplained muscle pain, muscle tenderness, muscle weakness, or general tiredness occur.

Earlier this month Bayer AG withdrew its brand of statin, Baycol, after it was linked to 31 deaths.

Public Citizen says there are grounds for special warning labels -- placed in black boxes to make them stand out -- based on the FDA's own Adverse Event Reporting System. The system received reports of 50 more deaths associated with the use of statin drugs since October of 1997, not including Baycol.

Statin drugs can dramatically lower "bad" cholesterol levels and triglycerides, boosting protective "good" cholesterol levels.

But in some patients, statins can caused muscle damage, even death. Symptoms associated with the more advanced problems include dark urine and fever.

Based on recently updated guidelines, 36 million Americans could be prescribed these drugs to keep their cholesterol in check. The FDA estimates there are currently about 20 million prescriptions for statins.

Statin drugs still on the market include: Pravachol from Bristol-Myers Squibb, Lipitor from Pfizer, Lescol from Novartis, and Zocor and Mevacor from Merck. Currently none of the statin drug labels have a black box warning.

In response to the Public Citizen action, a representative of Bristol Myers Squibb said there is "no need for a black box warning," claiming the company's product, Pravachol, is very safe.

The FDA said it is looking into the Public Citizen petition.