Millions of patients are taking prescription drugs to lower cholesterol without being fully aware of their potential side effects. If you are considering a prescription drug treatment for lowering your cholesterol, we recommend you click here to read the article Lower Cholesterol without Drugs by Dean Ornish, M.D.

In the next paragraphs we include an overview of prescription drugs—commonly used by medical doctors to treat high cholesterol—and their potentially serious side effects.

In the past, the prescription drug choices to treat elevated LDL (bad cholesterol) were the bile acid sequestrants (cholestyramine and colestipol) and nicotinic acid (niacin). Niacin in particular has troublesome side effects (e.g. itching, flushing) and therefore requires considerable patient education in order to achieve adherence. Other prescription drugs—gemfibrozil, probucol, and clofibrate—have proven to moderately reduce LDL cholesterol levels and effectively reduce other blood lipids (i.e. Triglyceride).

Nowadays other types of "more friendly” prescription drugs are being used for treating high cholesterol. They are HMG-CoA reductase inhibitors, which control the production of cholesterol in the liver and are commonly known as “statins” drugs. Examples of these commonly-prescribed—hundreds of millions of patients are taking them—statin drugs are: Lipitor/atorvastatin, Baycol/cerivastatin, Lescol/fluvastatin, Mevacor/lovastatin, Pravachol/pravastatin, Crestor/rosuvastatin, and Zocor/simvastatin.

Although statin drugs have proven effective for lowering LDL cholesterol levels, they have shown common short-term side effects and more importantly, long-term side effects are still unknown—data is still being compiled on a worldwide basis.

One of the statin's short-tem side effect has been clearly identified, muscle pain. Therefore patients taking statin prescription drugs must be very alert to the possibility of developing muscle pain, especially in the legs. Muscle pain is a well known side effect of statin drugs and might be an indication that more serious long-term side effects will develop. If you are under a cholesterol-lowering prescription drug treatment and you are feeling muscle pain, particularly in your legs, ask your doctor to regularly check your muscle enzymes to make sure they are within a normal range.

To better understand statin drugs, and their potentially serious side effects, we recommend you take the time to read thoroughly the following important reference information:

- Physicians often ignore or dismiss patient complaints about possible side effects of statin prescription drugs.

In October 2006, a team of researchers—led by Beatrice Golomb M.D., Ph.D. at the University of California San Diego—asked patients to help them fill a gap in research data being collected on statin drugs side effects. The effects currently being researched include: muscle pain, muscle weakness, fatigue, peripheral neuropathy, memory/thinking problems, and mood/personality changes among other symptoms. In an article published at the time, Dr. Golomb stated that nearly 60% of patients reported muscle weakness or fatigue, and about half reported cognitive problems. To read an article referring this research, click here.

In August 2007, a study published by Dr. Golomb's team in the journal Drug Safety concluded that physicians often ignore or dismiss patient complaints about possible side effects of statin prescription drugs. To read an article on this study, click here.

In November 2007, the same team of researchers reported to a meeting of the American Heart Association's Scientific Sessions 2007 that simvastatin, a popular statin drug commonly prescribed to lower cholesterol, could be the cause of disrupted sleep in some patients. To read more infomation about this study, click here.

- Scientists Identify Gene Responsible for Statin-induced Muscle Pain.

A recent study published in the December 2007 issue of The Journal of Clinical Investigation—co-authored by Vikas P. Sukhatme M.D., Ph.D., a professor of medicine at Harvard Medical School— offer the first evidence that a specific gene plays a key role in statin-related muscle pain. To read an article with important information on the findings of this study, click here.

- Lovastatin decreases coenzyme Q10 (CoQ10) levels in humans. Karl Folkers [et. al] theorized that the inhibition of HMG-CoA reductase would also inhibit intrinsic biosynthesis of coenzyme Q10 (CoQ10), an essential compound that facilitates the electron transfer in the mitochondria for the production of adenosine triphosphate (ATP), the usable unit of energy required in most metabolic processes within the body. In a three protocol study, Folkers and his collaborators found that Lovastatin did cause CoQ10 levels to drop. Furthermore, the directors of the study concluded that “although a successful drug, Lovastatin does have side effects particularly including liver dysfunction, which presumably can be caused by the Lovastatin-induced deficiency of CoQ10.” The study Lovastatin decreases coenzyme Q levels in humans was conducted by Folkers K., Langsjoen P., Willis R., Richardson P., Xia L.J., Ye C.Q.,Tamagawa H. Published in the Proc. Natl. Acad. Sci. U.S. 1990 Nov 87:22 8931-4. To read the study click here. For more information on Coenzyme Q10 (CoQ10) visit the section titled Nutrition on this Web site.

- Bayer Voluntarily Withdraws Baycol. In the year 2001, the consumer group Public Citizen conducted an analysis of the U.S. Food and Drug Administration's side-effect registry and discovered that statin drugs were linked to seventy two fatal, and seven hundred seventy two non-fatal cases of rhabdomyolysis between October 1997 and December 2000. In a letter dated May 21, 2001—addressed to the Health Care Professional community— the pharmaceutical giant company Bayer AG stated that in December 1999 the company had warned that the combined use of Baycol (Cerivastatin sodium tablets) with a triglyceride-lowering drug named gemfibrozil is contraindicated due to a risk for rhabdomyolysis and that "concurrent use should not occur under any circumstances." In August 2001, after the report was published, the pharmaceutical company Bayer voluntarily removed from the U.S. market its once high-flying statin drug Baycol (Cerivastatin). Baycol was suspected to be linked in the U.S. to at least thirty-one rhabdomyolysis-related deaths. To read the U.S. FDA communication "Bayer Voluntarily Withdraws Baycol", click here.

- Dangers of Rosuvastatin [Crestor] identified before and after U.S. FDA approval. Letters from the U.S.-based Public Citizen’s Health Research Group (PCHRG) and AstraZeneca were published by The Lancet with opposite points of views on the safety of the drug. According to PCHRG: (a) Patients taking Crestor have experienced severe muscle deterioration at a higher rate than patients taking other cholesterol-lowering drugs. (b) The rate of rhabdomyolysis for Crestor appears to surpass that of all other currently marketed statins. (c) From its approval in August 2003 to April 2004, eighteen patients, including eleven in the U.S., suffered severe muscle deterioration. In addition, the PCHRC letter states, eight cases of acute kidney failure and four cases of kidney insufficiency related to the use of Rosuvastatin have been reported. To read both letters, click here.

- Non-conclusive data about the potential relationship between statins and cancer.

In one paper published by the Journal of the American Medical Association (JAMA) researches raise the possibility of long-term statin use causing cancers. In the original paper, authors T.B. Newman and S.B. Hulley pointed out that all statin drugs have been shown to induce cancer in experimental lab rodents, and that in some cases the amount of statin causing cancer in animals matched dosages being prescribed to humans. While accepting that extrapolating incidence of cancer in rodents to humans is “an uncertain process,” the authors recommended that “lipid-lowering drug treatment, especially with the fibrates and statins, should be avoided except in patients at high short-term risk of Coronary Heart Disease (CHD).” Click here to read the paper Carcinogenicity of lipid-lowering drugs by Newman T. B., Hulley S.B., originally published in the JAMA 1996 Jan 3;275(1):55-60.

In June 2007, the Journal of the American College of Cardiology (JACC) published an editorial comment titled Low-Density Lipoprotein and Cancer by Anthony N. DeMaria MD, MACC and Ori Ben-Yehuda, MD, FACC. The paper presents non-conclusive data about the potential relationship between LDL, statins and cancer. To read two interesting articles on this important subject, click here.

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