Are you worried about scary news reports about your cholesterol pill? Should you stop it? Simply, the answer is "Don't worry." Read on.

Following the voluntary recall of Baycol by its manufacturer, questions about the safety of the other statin drugs have been raised by a consumer group. The concern is over the rare incidence of rhabdomyolysis in patients using Lipitor, Lescol, Mevacor, Pravachol or Zocor. Rhabdomyolysis is a condition of muscle inflamation in which muscles all over the body become inflamed and release a protein into the blood. If the process is long enough and severe enough, the protein clogs up the kidneys and causes kidney failure or even death. The FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol. 12 of these patients were also taking Lopid (Gemfibrozil), a triglyceride-lowering drug that combined with a statin has been known to increase the risk. By percentage, this complication rate is low (considering 8 million Americans are estimated to use statins), but it was significantly higher than the other statin drugs.

Patients who develop rhabdomyolysis usually have muscle aches involving their entire body, or at least in several muscles. An ache or pain in one muscle or joint is not rhabdomyolysis, but only arthritis or a muscle strain. The pain may be accompanied by weakness, fever, nausea, vomiting, and passing of dark urine. Severe muscle destruction and death are preventable if patients are aware of the early warning signs and stop the medication. If a patient were to develop muscle aches all over, he should contact his physician. Generally, the physician would temporarily stop the drug and do a blood test (CPK) to determine if any muscle damage is occurring. If the blood test is normal, the statin could be restarted or the patient could abe switched to another drug. It should be noted that around 5% of patients will develop mild muscle aches.

So what is the risk? There is considerable disagreement between the FDA and Ralph Nader's Public Citizen organization over how many cases occur. But even if you use Public Citizen's (probably inflated) statistics, the risk of a statin-user getting rhabdomyolysis is 1 in 750,000. The risk of a statin-user dying from rhabdomyolysis is 1 in 5,747,000.

To put this in perspective, one should consider the benefits of statin drugs. Statins can prevent up to 50% of heart attacks and coronary death in some study groups. Thousands of lives are saved every year because patients are taking statins. Patients receiving statins have fewer first and second heart attacks, need fewer bypass and angioplasty procedures, and are less likely to die from their condition. And there are no other drugs that are anywhere nearly as effective as the statins. Patients should not panic and stop their statin if they are not having any problems.


US News and World Report
Food and Drug Administration Q&A
Food and Drug Administration Press Release
msnbc report

Baycol
Lipitor
Pravachol
Zocor