Concerns Over Statins
50% of Americans have high cholesterol.
According to NDS Health, a health-care information services company based in Atlanta, more than 110 million prescriptions were written for statin drugs in 2001. But they're expensive … and they're not without risk.
Cholesterol-lowering drugs can result in serious side effects. In a clinical advisory issued recently, the American College of Cardiology, the American Heart Association and the National Heart, Lung and Blood Institute warned doctors about possible serious adverse effects and factors that could increase the risk of statin-caused muscle disorders.
In fact, in January 2002 Bayer Pharmaceutical announced that its cholesterol drug Baycol has been linked to approximately 100 deaths since its withdrawal from the market in August 2001, and Baycol was recalled after it was linked to about 40 deaths in the US. Bayer is currently facing several lawsuits from patients who were injured while taking the drug.
New York Times health writer Jane E. Brody recently reported (December 10, 2002) that last summer an 82-year-old Kansas woman died as a result of an undetected muscle disease caused by the statin she had been taking for years to control her cholesterol.
During the entire time she was taking it, the woman had muscle pains that doctors never attributed to the drug. "She even had a shoulder operation, which did nothing, of course, to cure the drug-induced pain that might have been correctly diagnosed through a simple blood test," wrote Brody. "Then she was mistreated with an anti-fungal agent for skin lesions that actually resulted, not from a fungus, but from the muscle breakdown caused by the drug."
It's been shown that when anti-fungals are combined with statins, they can greatly increase the risk and severity of muscle disorders. "Within three months, the woman's condition worsened and she became so weak she could not stand or breathe on her own. Two weeks later, she was dead," reported Brody.
Statins may also cause a liver disorder in about one percent of patients.
Public Citizen Calls for Stronger Warnings on Statins
Public Citizen, a consumer advocacy group, has petitioned the FDA for stronger warnings on all statin drugs in the wake of the August 2001 recall of Baycol. The petition asks the FDA to include a warning that muscle pain or weakness can lead to muscle damage.