In February of '98, Bayer Pharmaceutical announced the release of Baycol, a cholesterol-lowering drug that held the promise of helping thousands of individuals who suffered from high cholesterol. That promise proved more than elusive when, on August 8th, 2001, Bayer AG withdrew Baycol from the market after concerns about lethal side effects related to the breakdown of muscle cells. The drug is linked to 31 deaths in this country and 52 deaths around the world. At the time that it was pulled from the market, some 700,000 Americans were taking the cholesterol-lowering drug. Baycol, also called cerivastatin, is still available in Japan.

Baycol is an example of a statin, a type of drug that can significantly lower cholesterol and reduce the risk of heart attack. There are a handful of statins available on the U.S. market, including Baycol (withdrawn from the market on August 8th, 2001), Zocor, Pravachol, Mevacor, Lescol and Lipitor. While many of these statins have been linked to a potentially dangerous condition called rhabdomyolysis, only Baycol has resulted in fatal outcomes. (For more complete information on Rhabdomyolysis, refer to the webpage entitled, "RELATED DRUGS."

Statins

Statins are a group of medicines that block a certain liver enzyme that produces cholesterol. Basically, statins reduce cholesterol production in the liver. They do this by lowering LDL (A lipoprotein substances that acts as a carrier for cholesterol and fats in the bloodstream. High levels of LDL are undesirable.) Statins also raise HDL, a lipoprotein that carries cholesterol in the bloodstream. HDL is the good cholesterol in the body and has been correlated with a lower risk for heart disease. Statins have proved effective in lower the risk of heart attack in those individuals who have taken them.
Baycol or Cervistatin is a cholesterol-lowering drug that is classified as a statin. Statins are the most widely prescribed type of cholesterol lowering drug.

FDA's Role

Since 1998, the year that Baycol became available in the United States, there have been 12 prescription drugs taken off the market for concerns of dangerous side effects. Critics contend that much of the fault lies with the FDA who "fast track" drugs to market based on political pressure from drug companies and those who represent the interests of drug companies. Apparently this was not the case with Baycol, which was released onto the market after being reviewed by the agency for 11 months.

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The Danger Over Baycol

The real concern for patients is the development of the condition known as Rhabdomyolysis. This is a dangerous, and potentially fatal, condition where muscle cells enter the bloodstream and cause acute pain, often in the lower back and legs. In severe cases, the patient can experience kidney failure and die. This is what happened to 31 patients who were taking Baycol and experienced fatal outcomes. Symptoms of Rhabdomyolysis include muscle pain, weakness, and tenderness; fever; dark urine; nausea and vomiting.

Fatalities from taking Baycol seemed to be focused on three groups, including:

Of the 31 deaths that occurred in the U.S., 12 of them involved patients taking both Baycol and gemfibrozil.

Concerns over the health risks posed by Baycol had been brewing for many months as reports of fatalities trickled in. The first active response came from British regulators who banned high dosages of Baycol that seemed to be involved in those cases where fatalitites occurred.

The FDA finally asked Bayer to take the drug off the market in the United States after the fatalities occurred and at the urging of the consumer advocacy group Public Citizen, which is led by Ralph Nader. Public Citizen is urging the FDA to place stronger warning labels on all statins, as well as urging the manufacturers to provide consumers with special brochures that come with every statin and explain the associated risks.

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Bayer AG

Bayer executives have not counted how many Baycol victims suffered from fatal Rhabdomyolysis across the globe. This recall obviously hurts the company which was sent reeling from this news and a global economy that has suffered as of late. The result has been reported profits that are short of last year's earnings and well below previous estimates.

Executives at Bayer said they will continue to market and sell Baycol in Japan where it is prescribed at lower dosages and where the drug gemfibrozil is not available. Public Citizen has said it will urge Japanese regulators to take Baycol off the market here as well.

Appropriate Steps for Baycol Users

Patients now taking Baycol need to see their doctors about switching to a different drug. If you are taking one of the other statins that remain available (Zocor, Pravachol, Mevacor, Lescol and Lipitor), FDA spokespersons have said that there is no need to panic. These older drugs have been effective for many years for hundreds of thousands of patients. The FDA does not plan to strengthen the warning labels currently on statins or to ask other manufacturers to pull their products.

However, as a general rule, no statin should be used in combination with gemfibrozil, which heightens the risk of muscular disorders. Anyone taking a statin who experiences muscle pain should consult their doctor to make sure they are not at risk for certain side effects.