American College of Cardiology

The cholesterol-lowering drugs commonly known as statins are safe and effective for most patients. Patients on statins who are experiencing no side effects should continue taking the drugs and should talk with their doctors if they have concerns about the drugs' safety.

Statins have been studied closely and have proven to be a safe and effective way to help patients lower their cholesterol levels.

Statins, especially in combination with a good diet and regular exercise, have been proven to decrease the risk of heart attack and stroke, lessen the need for heart surgery and angioplasty, and reduce the risk of death significantly.

Baycol was recalled by its manufacturer because of 31 deaths related to a dangerous but rare side effect of the drug. The side effect, rhabdomyolysis, is a rare condition where damage to muscles in the body results in release of muscle cell contents into the bloodstream. When this happens, the kidneys and other organs can be damaged, sometimes enough to be fatal.

While this muscle damage is a known side effect of all statins, especially when they are taken in conjunction with other drugs called fibrates, it is an extremely rare side effect.

It appears that rhabdomyolysis may be more common with Baycol, so it was withdrawn from the market.

For most patients, the benefits of statin drugs in reducing the risk of heart disease and cardiovascular events far outweigh the risks of serious side effects.

All patients taking Baycol should stop its use and contact their physician to discuss switching to another cholesterol-lowering drug.

Patients on Baycol—or any statin, for that matter—who are experiencing muscle aches or have dark urine, should immediately discontinue the use of the drug and contact their physician.

Patients taking Baycol and gemfibrozil (Lopid and generic equivalents) should immediately discontinue the use of Baycol and contact their physician.

In the case of rhabdomyolysis, patients will feel muscle aches in their calves, back, or their entire body. Weakness, fever, nausea, vomiting, and passing of dark urine may accompany this pain.

If caught early, problems from side effects can be quickly and effectively treated. Physicians can also perform tests, including those for liver and kidney function and markers of muscle inflammation, to look for signs of problems possibly related to the drugs. These tests may identify whether patients are having side effects before any overt symptoms are displayed.

These tests are generally performed routinely to check on the effects of the statin.

Statins are a class of drugs that help to reduce the amount of LDL or "bad" cholesterol as well as increase the amount of HDL or "good" cholesterol. In so doing, statins help to prevent the buildup of fatty material in the arteries, a condition known as atherosclerosis.

Long-term studies of statins have proven that they are extremely effective and, when combined with a good diet and regular exercise, have helped save tens of thousands of lives. As a result, statins have proven to decrease the risk of heart attack and stroke, lessen the need for heart surgery and angioplasty, and reduce the risk of death in people with heart disease significantly.

Five other statin drugs besides Baycol have been approved by the FDA: atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor).

There are also other drugs approved for lowering cholesterol besides statins. Patients should consult their physician to determine which treatment is right for them.

Statins, like all prescription drugs, have side effects. In the case of statins, the most serious and the most rare is rhabdomyolysis. This condition is more likely to occur when statins are being taken in combination with drugs called fibrates.

While deaths have been associated with rhabdomyolysis caused by the use of other statins, it appears to be more common with Baycol, which is why it was withdrawn from the market.

In general, the risk of a fatal reaction to a statin drug is very low.

As is the case with all prescription drugs, however, patients should carefully follow their physicians' directions on their use and read the information included with the prescription to learn more about the drug's potential side effects.

Statins are often given in combination with fibrates, the most common of which is gemfibrozil (Lopid or generic equivalents).

In most cases, using these drugs simultaneously is perfectly safe and effective.

While there is an increased risk of rhabdomyolysis when these drugs are combined, it is still a very rare side effect.

To minimize the risk of this side effect, physicians carefully adjust the dosages you are taking of both medications and monitor for possible side effects. Such monitoring may include routine tests to assess your liver and kidney function and markers of muscle inflammation. If you have kidney disease, your risk of a side effect with this combination may be increased and you should consult your physician.

There are other drugs that increase the risk of side effects when taken with statins, including: erythromycin-type antibiotics, high doses of Niacin, cyclosporine, certain antifungal drugs, the antidepressant Serzone (Nefazodone), and HIV protease inhibitors.

Patients who are having side effects can often be switched to one of the other approved statins or another cholesterol-lowering drug.

Cholesterol-lowering drugs may be an important part of your doctor's plan for managing your cholesterol levels, so your physician will likely try to find another drug to help you achieve the appropriate changes in your cholesterol levels.

It's important to remember that the most important steps to improve your cholesterol and to reduce your risk for heart disease are those you can take without medications, especially maintaining a good diet and exercising regularly. Cholesterol-lowering drugs are an adjunct to these lifestyle changes.

For more information on a heart healthy diet, visit the National Heart, Lung, and Blood Institute Web site, or the American Heart Association Web site.