Cholesterol Lowering Drugs Can Cause Nerve Damage and Impotence, if they Don't Kill You First

New research from Denmark suggests that the Cholesterol-lowering drugs, known as statins, may increase the risk of neuropathy (nerve damage). Any side effects of the drugs must be weighed against this "very substantial benefit," according to Dr. Michael Donaghy, of the University of Oxford in the UK, who is the author of a related editorial. Donaghy notes that the study shows that polyneuropathy occurs in 1 out of every 2,200 patients who take statins. This nerve damage likely includes numbness, tingling and pain in the hands and feet, the Oxford physician points out. (Neurology 2002; 58:1321-1322, 1333-1337.)

In March 2000, Researchers discovered that the cholesterol lowering drugs known as statins can also cause impotence. They found 220 cases linking statins and impotence in the U.S. In Britain, a further 163 cases had been reported by family doctors to the Committee on Safety of Medicines. Harvey reported his findings in March at the annual meeting of the British Endocrine Societies.

Nerve Damage
As more and more people have started taking statins on a long-term basis, a small number of patients have developed cases of nerve damage. Dr. David Gaist, of the University of Southern Denmark in Odense, found that statins increased the risk of polyneuropathy.

Compared to a "control" group of people who did not have neuropathy, people who had taken statins were 4 to 14 times more likely to develop polyneuropathy that did not have a known cause.

Several of the statins taken by patients in the study list peripheral neuropathy as a possible side effect. However, even though statins may increase the risk of developing nerve damage, the findings should not discourage the use of the cholesterol-lowering drugs, according to Gaist. "The positive benefits of statins, particularly on reducing the risk of heart disease, far outweigh the potential risk of developing neuropathy," he said in a news release.

Impotence
The link between statin drugs and impotence was discovered by John Harvey and his colleagues at the University of Wales College of Medicine's unit at the Maelor Hospital in Wrexham. Harvey discovered the link with impotence by accident through his research into diabetes. Diabetes sometimes makes men impotent, so Harvey and his colleagues wanted to check if medication increased the risk.

Most of the men affected were in their mid-50s, though some were as young as 30. More than half of the 220 men identified by Harvey recovered their virility after their doctors switched them to different types of statins, but the rest remained impotent. Simvastatin, marketed as Zocor by Merck Sharp & Dohme, caused 77 cases, by far the most linked to a single drug. Of these, 44 recovered after switching drugs.

Rhabdomyolysis & potentially fatal kidney or other organ failure
According to the Food and Drug Administration., Bayer Pharmaceuticals voluntarily withdrew the statin drug Baycol from the market on August 8, 2001, following reports of 31 deaths due to rhabdomyolysis, a severe side effect of the statin drugs that destroys muscle cells then releases them into the bloodstream. The disorder can cause severe muscle pain, frequently in the calves or lower back. In rare instances the effects are so severe, patients develop potentially fatal kidney or other organ failure. Symptoms include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting.

Experts say rhabdomyolysis is a known side-effect of all statins. According to Paul Doering of the University of Florida's College of Pharmacy, the drugs have remained on the market because "the positive benefits of the drug outweigh the rare frequency of occurrence." But Baycol stands out because it has caused a significantly higher number of reported deaths, especially when used in high doses, in elderly patients, and particularly when combined with another cholesterol-lowering drug called gemfibrozil, also known as LOPID.

Doering blames the FDA's approval process for Baycol's recall: "This recall highlights a broader problem, and that is the inability of the drug approval process to predict what the true nature of any drug is, based solely on the data required for an NDA [new drug application]. "It has taken this long for enough data to accumulate for the FDA to finally drop the ax. This begs the question: What is the threshold after which the benefits no longer outweigh the risks? The answer, of course, would depend on the drug and the disease which it treats."

The Cholesterol lowering statin drugs pose several serious risks. The clear and complete explanation of these risks should be required of all physicians who prescribe them. Patient drug information should likewise be more clear, frank and complete in revealing these risks. For information about natural alternatives, please click here: