Eight million Americans use statins, a widely
prescribed class of drugs for lowering cholesterol. Research
has established that statins reduce the risk of heart attacks
and strokes. Though statin drugs lower cholesterol more effectively
than other cholesterol lowering drugs, researchers have linked
statin drugs to numerous cases of a rare condition known as rhabdomyolysis.
Researchers find that patients taking a particular type of statin,
Baycol, have a much higher frequency of rhabdomyolysis cases
than the other five statin drugs available in the United States.
When reports surfaced of rhabdomyolysis related deaths in Baycol
patients, the medical community began attributing statins to
rhabdomyolysis. The Baycol link to rhabdomyolysis led the FDA
to issue a voluntary recall of the statin drug on August 8, 2001.
Since that time, questions have surfaced regarding the safety
of all statins and the potential health effects of rhabdomyolysis.
Enthusiastic accounts of the effectiveness and safety of statin have made it the third most popular drug in the United States in prescriptions filled, and the largest drug in dollar volume. Highly popular - and highly priced - statins appeared on the market nearly 15 years ago to combat high cholesterol and reduce the risk for heart disease. Now, millions of Americans, both with severely and moderately high cholesterol take one brand of statin or another.
Cardiologists praise statins' ability to
drastically lower cholesterol levels. These drugs block cholesterol
production in the body by inhibiting the enzyme called HMG-CoA
reductase. Statins reduce the amounts of LDL (bad) cholesterol
and total cholesterol in the blood. It also reduces the amounts
of triglycerides (another type of fat) and apolipoprotein B (a
protein needed to make cholesterol) in the blood. In addition,
the drug increases the amount of HDL (good) cholesterol in the
blood. Consequently, statin reduces the risk of hardening of
the arteries, which can lead to heart attacks, stroke, and peripheral
Although the medical community associates every type of statin with rhabdomyolysis, researchers found rhabdomyolysis occurs more frequently in patients using cervistatin, a type of statin that Bayer Pharmaceuticals produces and markets under the brand name Baycol. The Food and Drug Administration (FDA) approved Baycol in 1997. Now, among all statins, the FDA considers Baycol a significantly greater risk for causing rhabdomyolysis related fatalities.
In August 2001, after the FDA attributed 416 cases of severe muscle damage, including thirty-one deaths to Baycol, Bayer instituted a voluntary recall of the drug. Since Bayer recalled the drug the FDA has only limited power to make certain patients aware of the recall. As a result, some patients continued to take Baycol long after the medical community became aware of its serious health effects.
Fatal rhabdomyolysis related to Baycol occurred most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (Lopid and generics), another lipid lowering drug. To date, the FDA has received reports of fifty-two U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, twelve of which involved concomitant gemfibrozil use. Other reports link combinations of statins and other drugs, including warfarin (used to prevent blood clotting), ketoconazole (an antifungal drug) and clarithromycin (an antibiotic) to rhabdomyolysis.
A survey conducted at one hospital indicated that a large number of patients were unaware of the recall or statin's relationship to rhabdomyolysis. Of the patients still prescribed the Baycol/ gemfibrozil combination, only a fifth had heard of the Baycol recall. Forty percent of the Baycol surveyed patients had symptoms of muscle damage, with almost half of these cases being severe. Consumer advocacy organizations have criticized Baycol's manufacturer for failure to take earlier action in warning the patients of Baycol's side effects and for failure to sufficiently publicize the subsequent recall of the drug.
A person taking a statin should keep a few points in mind. Lifestyle changes can help lower and maintain cholesterol levels. A diet that contains foods low in total fat and low in cholesterol can aid in the reduction of cholesterol. Increased physical activity and weight loss can also aid in the management of cholesterol. In addition, if a person taking a statin develops muscle symptoms, such as muscle aches or cramping, the person should alert his or her doctor immediately. The doctor will likely order a blood test called a CK (creatine kinase) test that assesses whether muscle damage exists. Persons taking statin to whom doctors prescribe antibiotics or antifungal agents should inform the prescribing doctor of their statin prescription because of a possible interaction.