As soon as they hit the market in the late 1980s, statin drugs revolutionized the fight against heart disease. For the first time, anyone could dramatically lower LDL cholesterol by simply taking a pill. Best of all, the drugs seemed to be safe. Only a small percentage of patients ever complained of side effects, a rare occurrence in the world of prescription drugs. At least one company even asked the Food and Drug Administration for permission to sell statins over the counter.

And then reports of serious side effects and even deaths began trickling in. The FDA received reports that 31 people died as a result of complications from taking cerivastatin (Baycol), a popular statin manufactured by Bayer. In every case, the drug caused a breakdown of muscle cells, a condition called rhabdomyolysis. The contents of the cells spilled into the bloodstream, eventually overloading the kidneys until they shut down. Bayer voluntarily withdrew the drug from the market on Aug. 8, 2001.

Long before Bayer pulled the plug on Baycol, doctors knew that like all drugs, statins carried some risks. In fact, every statin -- including lovastatin (Mevacor), rosuvastatin (Crestor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor) -- has been linked to isolated cases of rhabdomyolysis in the past. In a 2001 petition to the FDA calling for stricter labeling for statins, the advocacy group Public Citizen reports that statins other than Baycol have caused at least 81 deaths and 385 cases of rhabdomyolysis, most resulting in hospitalization.

Unfortunately, few patients were even aware of the danger, according to Larry D. Sasich, PharmD, a research associate with Public Citizen. Although all statins contain labels that warn of the possibility of developing a life-threatening case of rhabdomyolysis, the labeling is "extremely inconsistent and inadequate," according to Public Citizen. "Warning labels are written in tiny print and are full of technical jargon," Sasich says. "Only a small percentage of patients [are fully informed] about possible adverse drug effects."

Every patient with a prescription for a statin should know the early symptoms of rhabdomyolysis. The condition causes muscle pain or aches, tenderness, or weakness, most often in the calves and back. Other possible indications include general weakness, tiredness, fever, nausea, vomiting, and dark urine. If you're taking a statin and notice these symptoms, particularly muscle pain, the American Heart Association advises you to stop taking the drug IMMEDIATELY and call your doctor right away. Fast action -- including no longer taking the statin -- can usually prevent any long-term damage.

In its petition to the FDA, Public Citizen stated: "Prompt cessation of the use of statins at the first sign of muscle weakness or tiredness and prompt evaluation by a physician, including a blood test for creatine phosphokinase (a measure of muscle destruction) may avoid the progression to more extensive muscle damage, rhabdomyolysis, and death."

Patients who take a statin along with the drug gemfibrozil (Lopid, also available as a generic) are especially vulnerable to rhabdomyolysis. Of the 31 patients who died while taking Baycol, 12 also used gemfibrozil, a drug often prescribed to lower triglycerides. Patients with weakened kidneys or hypothyroidism are also at increased risk.

Following the voluntary recall, Bayer advised physicians to switch all patients on Baycol to another cholesterol-lowering drug.

No matter which statin you take, be aware of other possible side effects as well. About one out of 100 patients develops a high count of liver enzymes, a sign of liver damage. Your doctor will check your enzymes before prescribing a statin and from time to time afterward. If your enzyme count climbs too high, you'll have to stop taking the drug. To further protect your liver, you should go easy on alcohol -- or avoid it completely -- while taking a statin.

Statins can interact with several other drugs, including some antifungal medications, as well as cimetidine (Tagamet), ranitidine (Zantac), warfarin (Coumadin), digoxin, erythromycin, and niacin. Be sure to tell your doctor if you're taking these or any other medications.

In 2001, Public Citizen urged the FDA to put "black box" warning labels on all statins. This is a label used for drugs with unusually serious side effects and would mean that statins could not be advertised directly to consumers or sold over the counter. The FDA has since issued a health advisory for rosuvastatin (Crestor), which can lead to a greater risk of rhabdomyolysis in certain populations, especially Asian-Americans. The manufacturer revised the package insert to reflect that risk and provided new recommended doses as well. In 2008, the FDA also warned healthcare providers that combining simvastatin (Zocor) with amiodarone increases the risk of rhabdomyolysis.

The American Heart Association and the American College of Cardiology have issued a joint statement agreeing that the benefits of statins -- strong protection against heart attacks -- far outweigh the risks. In May 2001, the National Cholesterol Education Program reported that as many as 36 million Americans should be taking a statin or other cholesterol-lowering medication.

In fact, the biggest danger with statins may be underuse. According to a report in the journal American Family Physician, many patients stop taking the drugs without their doctor's consent, thus opening the door to heart disease.

If your doctor has prescribed a statin, follow the instructions and the warnings to the letter. You should also try to control your cholesterol by exercising regularly and eating a low-fat diet. If your cholesterol drops far enough, you may be able to leave statins behind. As always, the safest drug is the one you no longer need.

-- Chris Woolston, M.S., is a health and medical writer with a master's degree in biology. He is a contributing editor at Consumer Health Interactive, and was the staff writer at Hippocrates, a magazine for physicians. He has also covered science issues for Time Inc. Health, WebMD, and the Chronicle of Higher Education. His reporting on occupational health earned him an award from the northern California Society of Professional Journalists.

References

Last updated July 27, 2009
Copyright © 2001 Consumer Health Interactive