By David Brown

The maker of Baycol (cerivastatin), a popular cholesterol-lowering drug used by about 700,000 Americans, voluntarily pulled the medicine off the market August 8 because of numerous deaths associated with its use.

Officials at the Food and Drug Administration said 31 people have died of complications of severe muscle breakdown, a rare but well-recognized side effect of many cholesterol-lowering drugs. In about one-third of the cases, the person was on a second cholesterol drug, gemfibrozil, known to especially increase the risk of problems.

Baycol is one of six "statins," a popular family of drugs prescribed to about 12 million Americans to treat, and possibly prevent, coronary heart disease. Reports of severe side effects, including death, are at least 10 times more common for Baycol than for other drugs in the class.

The FDA is currently not considering any regulatory action with regard to the other approved statins which are lovastatin (Mevacor), pravastatin (Pravachol), Zocor (Zocor), fluvastatin (Lescol) and atorvastatin (Lipitor).

Bayer AG, the German company that makes Baycol, introduced the drug under the trade name Baycol in January 1998. The first death was reported in January 2000, with the number of complications rising markedly when a high-dose pill was introduced last August.

Before and after the first death, Bayer officials warned doctors against prescribing Baycol with gemfibrozil and strongly advised that patients be started on a low dose. That advice, and changes in Baycol's official labeling, appeared to change prescribing behavior to some extent, but not enough to eliminate the problem.

Drug recalls are rare. From 1981 to 2000, the FDA approved 543 new drugs for use. Fourteen, or 2.6 percent, were subsequently recalled -- either voluntarily, or by FDA action -- for safety reasons.

Baycol is fifth out of the six statins in number of prescriptions written, according to data provided by IMS Health, a pharmaceutical monitoring company in Pennsylvania. But the drug's market share was growing. It was 6.7 percent at the end of June, up from 2.5 percent at the end of 2000.

The drug is the third biggest selling prescription drug in Bayer's portfolio. Worldwide, it accounted for $560 million in sales last year, and was expected to grow to about $880 million this year.

Baycol, which is used worldwide by about 6 million people, is also being taken off the market in Europe. It will remain available only in Japan, where gemfibrozil is unavailable.

Physicians have known since the first statin was introduced in 1987 that a few patients develop muscle inflammation, experienced as soreness or tenderness, while taking the drug.

Occasionally, that progresses to whole-scale muscle breakdown, a condition called rhabdomyolysis. That, in turn, can lead to kidney failure, as the bloodstream is flooded with relatively toxic proteins released by the dissolving tissue. Jenkins said 29 of the 31 people who died had kidney failure.

People at increased risk for the complication are those taking both Baycol and gemfibrozil (sold under the trade name Lopid), and those taking the 0.8 milligram Baycol dose. The FDA advised people in those groups to stop taking Baycol and consult their doctors about alternative medicines.

Some deaths have also occurred with use of the 0.4 milligram pill, and when the drug is taken alone. The elderly, and possibly women, also appear to be at higher than usual risk for the complication.

Combination use of statins and fibrates -- the family to which gemfibrozil belongs -- isn't necessarily a mistake. The two types of drugs alter blood fats in different ways, and are sometimes intentionally prescribed to patients with severe cholesterol problems despite the rare risk of rhabdomyolysis, which generally reverses itself if the drugs are stopped immediately.

Washington Post August 9, 2001; Page A01