Groups: Statin benefits outweigh risks

Several sudies have found that statins can reduce the risk of death in patients with heart disease.

BETHESDA, Maryland (CNN) -- In response to recent questions about popular cholesterol lowering drugs called statins, two national medical groups are trying to reassure patients that the medicines are safe and effective.

"More than a decade of medical research has shown that statins prolong lives and prevent heart disease by effectively lowering serum cholesterol levels," the American College of Cardiology (ACC) and the American Heart Association (AHA) said in a joint statement.

Earlier this month, Bayer AG voluntarily withdrew its statin drug, Baycol, after 31 deaths were linked to it.

That action "prompted some patients to stop taking their other statin drugs," the groups said. "Many others have expressed serious concern about whether they are safe."

Dr. Douglas Zipes, president of the ACC, said, "the benefits of using statins to manage a patients' cholesterol far outweigh the risks of serious side effects from their use." He noted that all drugs have side effects.

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The five other statins still on the market "have a proven track record of effectiveness and safety despite the withdrawal of Baycol," the AHA and ACC said.

Those five statins are: Pravachol from Brystol Myers Squibb, Lipitor from Pfizer, Lescol from Novartis, and Zocor and Mevacor from Merck.

"Statins significantly reduce the risk of heart attack and stroke," said Dr. David Faxon, president of the AHA. He cited multiple large studies that have shown that statins can reduce the risk of death in patients with heart disease by as much as 30 percent.

The consumer advocacy group Public Citizen petitioned the U.S. Food and Drug Administration to add a "black box warning" to the label of some of the cholesterol-lowering drugs to warn patients of the possible side effects. They say the drugs destroy muscle and in rare instances the dead muscle cells can cause kidney failure and deaths.

The symptoms would include muscle pain, tenderness and weakness. As the problem advanced, patients could experience dark urine and fever.

In its petition, Public Citizen cited FDA records that show an additional 50 deaths have been linked to statin drugs other than Baycol since October 1997. The FDA said it is reviewing the petition.

The safety of statins will be among the topics of discussion at the annual meeting of the European Society of Cardiology which convenes this weekend in Stockholm.