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American Morning

Statin Drugs for Cholesterol May be Deadly

Aired August 20, 2001 - 11:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
LEON HARRIS, CNN ANCHOR: A consumer group today is demanding a new warning label on an entire class of popular cholesterol-lowering drugs. Millions of Americans take these drugs, which go by brand names such as Lipitor, Zocor and Pravachol.

CNN medical news correspondent Rea Blakey joins us now from Washington. She's got the details of all of that. Good morning, Rea.

REA BLAKEY, CNN MEDICAL CORRESPONDENT: Good morning, Leon. That consumer group, Public Citizen, they are calling for changes in labeling and increased awareness regarding the most widely prescribed cholesterol lowering drugs in the U.S. Based on recently updated guidelines, 36 million Americans could be prescribed to take these drugs to keep their cholesterol in check.

Now, statin drugs can dramatically lower bad cholesterols and triglycerides boosting protective, good cholesterol. But in some patients, statins can cause muscle damage, even death. Now, the muscle problems are mentioned in these full page ads from some statin drug makers in several major U.S. newspapers today. Some are offering Baycol patients a free month's trial supply, more on that in just a moment.

Now, Public Citizens says there's grounds for the labeling changes and increased health warnings based on the FDA's own adverse event reporting system, which received reports of 50 deaths associated with the use of statin drugs since October of '97, now that's in addition to the 31 deaths that prompted the makers Baycol to pull their product from the shelves recently.

Now, I want to show you this. This is a copy of the class-action suit filed against Bayer Corporation, the makers of Baycol, claiming product liability and negligence on behalf of the citizens of the state of Pennsylvania.

Now, the statin drugs that are still on the market include Pravachol from Bristol Myer Sqibb, Lipitor from Pfizer, Loscol from Novartis, and Zocor and Mevacor, both from Merck.

Now, Public Citizen wants the FDA to require statin drug manufacturers to add a highly visible and mandatory warning box, a black box on the outside of the packaging, and some consistent bold lettering warnings inside the drug package. It's recommending patients be warned of a risk of muscle deterioration when explained muscle pain, muscle tenderness or even weakness occur, also general tiredness. Now, symptoms associated with more advanced problems include dark urine and fever.

Currently, none of the statin drug labels have a black box warning, and only two, the ones by Merck, Zocor and Mevacor, mention ways to reduce the risk of muscle problems in patients who are taking those medications. And the answer there, Leon, is to stop taking the drugs.

HARRIS: Let's hope the folks get the message. Rea Blakey, in Washington. Thank you very much.

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