The decision last week by the German company Bayer AG to withdraw the cholesterol-lowering statin drug Baycol from the market after it was linked to 31 deaths left 700,000 Americans scrambling to find a new drug. It also left the millions who are taking other statins wondering whether the entire class of medications is safe.

Experts expect most Baycol users to be put on one of the five statins that remain on the market. But like Baycol, those drugs are linked to the same rare muscle weakness, known as myositis, which occurs in about 1 in 1,000 statin users, according to James Cleeman, director of the National Cholesterol Education Program at the National Heart, Lung, and Blood Institute.

That condition occasionally progresses to rhabdomyolysis -- a complete breakdown of muscle cells that can lead to kidney failure and death. How many cases occur is not known, because of limited post-market surveillance by the Food and Drug Administration (FDA).

Even so, Cleeman says the benefits of statins "far outweigh the risks.

People taking Baycol need to talk to their doctor about what drug they should switch to.

And people taking other statins should continue to take them because they are many, many times more beneficial" than they are risky.

But the Baycol experience illustrates the growing potential for medical complications and drug interactions as Americans increasingly rely on numerous pharmaceuticals to control chronic conditions such as elevated cholesterol, high blood pressure, arthritis and diabetes. In about a third of the Baycol cases, deaths occurred among people who also took gemfibrozil, a drug used to lower triglyceride levels.

Other reports in the scientific literature link combinations of statins and other drugs, including warfarin (used to prevent blood clotting), ketoconazole (an antifungal drug) and clarithromycin (an antibiotic) to rhabdomyolysis.

Even the experts are struggling to sort out the extent of the problem. "Who knows what the risks are?" says pharmacologist and physician Raymond Woosley, vice president at the University of Arizona's Health Sciences Center in Tucson. "You can find out on the Internet how many suitcases are lost in air travel, but who knows how many people are harmed by drugs?"

Consumer advocate Sidney Wolfe, director of the Public Citizen Health Research Group, believes statin complications may be greater than previously thought. He and his group are reviewing FDA statin data from the past three years and plan to petition the agency to require all statin drug labels to feature a more explicit warning about the side effects.

Until the facts are more clear, here is what you need to know if you take Baycol -- or any statin:

Any of them can cause myositis. Some experts believe that pravastatin (Pravachol) and fluvastatin (Lescol) may have less potential for drug interactions, but the data aren't sufficient to declare one drug safer or more dangerous than the others.

Watch carefully for muscle tenderness or weakness. Although muscle weakness occurs only rarely, given the 12 million statin prescriptions written yearly in the United States, that works out to thousands of cases.

Look for "feelings of achiness or weakness that can be localized or diffuse and can occur independent of exercise," says Sidney Smith, chief science officer of the American Heart Association. Fever can be another symptom of muscle weakness. Seek immediate medical attention if your urine turns brown -- a symptom of muscle proteins' being excreted through the kidneys.

Ask about getting a blood test. Liver function blood tests are routinely performed before statins are started and again 10 to 12 weeks later to ensure no problem is emerging. But you need another blood test -- either creatine kinase (CK) or creatine phosphokinase (CPK) -- to monitor whether muscle cells are breaking down.

Experts say this test should be performed if any muscle weakness is experienced. Some also believe that the test should be used routinely to screen for muscle weakness, but this remains controversial.

Tell your doctor what other medications you take. You've heard this before, but it's absolutely crucial with the statins. Deaths have been reported not only in people who also took Baycol with gemfibrozil, but in those who took other statins with other drugs, including cyclosporin.

Don't forget to tell your doctor if you take any over-the-counter medications, dietary supplements or herbal or botanical substances.

For more information on statins: please see the related links below.

Washington Post August 14, 2001; Page HE03