Baycol

BAYCOL (or Lipobay and Cerivastatin) is a drug used to lower LDL (bad) cholesterol levels, thereby reducing the probability of a heart attack. Baycol belongs to a class of drugs known as statins that are designed to block the production of an enzyme that generates LDL.

It is very powerful and is therefore prescribed in low doses of 0.4 and 0.8 milligrams (mg). Baycol was released in the United States in 1997 by Bayer [Page 86]AG, an enormous German conglomerate that manufactures chemicals and pharmaceuticals for global distribution.

By 1998, reports were being forwarded from physicians indicating adverse side effects from Baycol. In 1999, the Food and Drug Administration (FDA) approved the use of a potent dosage (0.4 mg) of Baycol. Several million people worldwide were taking Baycol and, in the process, were generating several hundred million dollars in profits for Bayer AG.

In 1999, Bayer AG responded to growing reports regarding the dangers of Baycol by issuing a warning on the drug's label and sent notices to doctors about the risks of prescribing Baycol in conjunction with a cholesterol drug called gemfibrozil, known on the market as Lopid.

In 2000, Bayer AG received approval from the FDA for a stronger, 0.8 mg version of Baycol even though the company had received a growing body of information stating that Baycol users were at a significantly higher risk of contracting rhabdomyolysis, a condition that dissolves muscle cells, releasing toxic chemicals into a patient's blood. Symptoms of rhabdomyolysis include, among others, dark urine, severe muscle pain, fever, dizziness, and vomiting—leading to an increased risk of kidney failure, paralysis, and (ironically) heart disease. By August 2001, the FDA announced that 31 Americans had died from taking Baycol with an unknown number of patients otherwise injured from the medication.

Also in August 2001, Bayer AG announced that it would remove Baycol from all global markets except Japan. Several hundred lawsuits against Bayer AG were settled, while several thousand additional lawsuits were ongoing. The company suffered a significant drop in its share values and has lost hundreds of millions of dollars in revenues and settlements, firing thousands of employees in an attempt to recoup these losses. Particularly noteworthy is the growing evidence that Bayer AG knew of the potentially lethal side effects of Baycol, but continued to market the drug. Its company report in 2001 stated that “The safety and health of our patients [has] priority over economic interests.”

Roughly 100 deaths and 1,600 injuries have been reported in connection with Baycol use since 1997. Additional claims of injury continue. No criminal charges have been filed against Bayer AG as of early 2004.