Downside to Statins
Like all drugs, statins have their drawbacks. While they're deemed extremely safe, given the large number of people who take them and the fact that they've been in use for more than 14 years, in rare cases they can cause problems. Among the potential side effects:Muscle and kidney damage. In 2001 Bayer AG voluntarily recalled its statin drug, Baycol (cerivastatin), from the U.S. market because of reports of at least 31 deaths in the United States linked to the drug. The deaths were the result of a condition called rhabdomyolysis, in which muscle cells break down, releasing proteins that become trapped in the kidneys. This interferes with the kidneys' ability to filter out toxins from the blood, leading to kidney failure and, potentially, death. Symptoms include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may occur throughout the body.
While all statins have been associated with very rare reports of rhabdomyolysis, according to the FDA the risk was 16 to 80 percent higher with Baycol, particularly when used at higher doses, in elderly patients, and in combination with Lopid (gemfibrozil), another lipid-lowering drug. The rhabdomyolysis risk associated with the statins that remain on the market, especially when the drugs are used alone by people without rhabdomyolysis risk factors such as renal impairment, is extremely small.
Much less serious is the muscle weakness or pain experienced by some people taking statins. You're more susceptible if you're older than 80, have a small body frame or are frail, have a multisystem disease (such as chronic renal insufficiency), or take multiple medications. Generally about 5 percent of people taking statins will experience these side effects. They usually go away once the drug is stopped and can often be prevented by taking coenzyme Q10.
Taking certain drugs while you're also taking statins might increase your risk of muscle damage. These drugs include: fibrates; nicotinic acid; the antifungals Sporonox (itraconazole), Nizoral (ketoconazole), and anything in the azole class of drug; antibiotics such as erythromycin and clarithromycin; the immunosuppressant Sandimmune (cyclosporine); HIV protease inhibitors; antidepressants such as Serzone (nefazodone); the beta-blockers Calan (verapamil) and Isoptin (verapamil); and the anti-arrhythmia drug Cordarone IV (amiodarone). As always, be sure to tell your doctor about all medications you are taking.
Liver damage. Like most drugs, statins are broken down in the liver, thus putting additional stress on the organ. That's why your doctor will monitor your levels of liver enzymes -- an indication of the health of your liver -- for the first few months that you are taking the drugs. You should also limit your use of alcohol, which puts additional stress on your liver and increases the risk of liver failure if you're taking statins (or other medications). Elevated liver enzymes occur in 0.5 to 2 percent of people taking statins -- generally those taking the highest doses. Full liver failure is extremely rare, and reducing the drug dose usually reverses elevated enzymes.
Depletion of coenzyme Q10. Statins also seem to decrease the body's production of the important substance coenzyme Q10. Cells need CoQ10 to help them use energy. That's why we recommend you supplement with 100 milligrams daily of CoQ10 if you take statins.
Cataracts. Statins alone don't cause cataracts. But according to a study published in the Archives of Internal Medicine in September 2001, taking Zocor along with the antibiotic erythromycin might increase the risk. Just a single course of antibiotic, typically taken for 10 days, appeared to double the risk of cataracts, while two or more courses tripled it. If you take statins and need antibiotics, talk with your doctor.
Nerve damage. Researchers studying 500,000 Danish residents found that people who took statins were more likely to develop a form of nerve damage called polyneuropathy than those who never took the drugs. The condition, also known as peripheral neuropathy, results in weakness, tingling, pain in the hands and feet, and difficulty walking. Taking statins for one year increased the risk of nerve damage about 15 percent, or one case for every 2,200 patients; for those taking the drug two or more years, the risk increased 26 percent.



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