Cholesterol-lowering drugs may do more harm than good

Nutrition Health Review, Fall, 2002

It always pays to do your research and read the fine print, even when taking a seemingly safe drug.

The group of drugs classified as statins--most notably lovastatin (Mevacor[R]), pravastatin (Pravachol[R]), simvastatin (Zocor[R]), and atorvastatin (Lipitor[R])--are used by a large number of people to control high cholesterol levels. The medications' own prescribing information warns of countless adverse effects and contraindications.

"Active liver disease or unexplained persistent elevations of serum transaminases" tops the list of contraindications on one leading simvastatin drug. "Liver Dysfunction--HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function" is listed as a warning on an atorvastatin calcium drug. The warning goes on to say that jaundice developed in one patient in clinical trials.

Liver damage is not the only drawback to statin drugs.

In August 2001, Bayer Pharmaceutical Division announced a voluntary withdrawal of Baycol[R] (cerivastatin), a popular drug used to lower cholesterol. Approved in 1997, Baycol[R] was touted as a "miracle drug" that blocked a specific enzyme in the body that is involved in the creation of cholesterol. Unfortunately, a significant amount of patients developed rhabdomyolysis--a condition in which serious muscle damage results in release of muscle cell contents into the bloodstream--as a result of Baycol[R] treatment. Rhabdomyolysis has been known to cause fatal kidney damage as well as damage to other vital organs. Most patients complaining of this condition require hospitalization. Fatal rhabdomyolysis was reported most frequently when used in higher doses, with elderly patients, and when taken with gemfibrozil (Lopid[R] and generics).

According to a study published in 2002 in Biological Psychiatry, a woman taking medication for schizophrenia along with lovastatin developed a prolonged QTc, a measure of the heartbeat. On the day she was scheduled for a routine test, she took 20 milligrams of lovastatin, double the dose prescribed, because she had missed a dose. Doctors lowered her dosage of lovastatin to 5 milligrams per day, and her QTc returned to normal one day later.

The remaining statin-class drugs are generally considered safe, but the literature for both Lipitor[R] and Zocor[R] mentions numerous ailments associated with statin therapy. Among the side effects listed are muscle cramps, loss of libido, dysfunction of certain cranial nerves (including alteration of taste and impairment of extraocular movement), facial paralysis, breast enlargement, incontinence, sweating, acne, and uterine hemorrhage. Zocor[R], according to its literature, occasionally causes myopathy, "which is manifested as muscle pain or weakness associated with grossly elevated creatine kinase."

According to the May 14, 2002, issue of Neurology, statin drugs can also increase the risk of peripheral neuropathy, a condition characterized by weakness, numbness, and pain in the hands and feet as a result of damage done to the peripheral nerves. Patients taking statin drugs were 14 times more likely to develop peripheral neuropathy than those not taking the medication. Taking statins for extended periods of time increased the risk.