Rea Blakey: Monitor statin use closely

CNN Health Correspondent Rea Blakey

The consumer advocacy group Public Citizen wants the U.S. Food and Drug Administration to issue a warning about cholesterol-lowering drugs called statins, marketed under various brand names. The group says muscle deterioration can result from use of the drugs. CNN Health Correspondent Rea Blakey answers questions that might be asked by people prescribed the drugs.

Q. If you are taking these drugs, what kind of precautions should you take?

A. As always, consult your physician or health-care provider should you be experiencing any side effects. The real concern regarding statin cholesterol-lowering drugs is the possible development of a rare and possibly fatal condition called rhabdomyolysis in which muscle cells are destroyed and released into the bloodstream. In a worst-case scenario, patients develop kidney failure.

If you develop muscle symptoms, let your doctor know immediately so that you can get a blood test called a CK (creatine kinase) test to determine if muscle damage is present. Muscle pain, tenderness or weakness, or a general feeling of tiredness could be possible symptoms of rhabdomyolysis, a muscle-deteriorating disease. Dark urine and fever are also symptoms.

Q. If you don't have signs of muscle tiredness or other symptoms, should you still be worried?

A. Statin drugs, like so many other medications, can also cause liver problems. Changes in liver function occur in just a small fraction of patients taking statins, according to medicalreasoning.com. Your doctor should routinely monitor your liver's function. If it becomes abnormal, you'll likely be taken off statin drugs, and liver function should return to normal.

Outside of liver concerns and rare instances of muscle deterioration problems, statin drugs are extremely effective in reducing bad cholesterol levels and protecting patients from heart attack and stroke.

Q. How many people subscribe to these cholesterol-lowering drugs?

A. Before the National Cholesterol Education Program revised cholesterol treatment guidelines in May, an estimated 13 million Americans had been prescribed statin drugs. At that time NCEP predicted nearly three times as many Americans could be prescribed the cholesterol-lowering drugs based on the newest guidelines. The FDA estimates some 20 million Americans are currently taking statin drugs.

Q. Has anyone confirmed that the 50 deaths mentioned by the consumer advocacy group were actually caused by these "statin drugs"?

A. The figure of 50 additional statin drug-related deaths comes from the FDA's own Adverse Event Reporting System. Obviously, it's possible that other deaths have occurred but have not been associated or reported to the FDA's system. The total number of statin drug-related deaths reported to this system since October of 1997 is 81. Thirty-one deaths were reported among patients taking Baycol (Bayer AG voluntarily pulled its product off the shelves). The remaining 50 represent deaths reported among patients taking the five other statin drugs: Lipitor, Pravachol, Zocor, Mevacor and Lescol.