Bayer AG is still trying to recover from the scandal surrounding the recall of its anti-cholesterol drug Baycol in August 2001. Baycol was a popular statin drug that was linked to rhabdomyolysis, an often-fatal destruction of muscle. Between Baycol’s launch in 1998 and its withdrawal in 2001, U.S. doctors wrote nearly 10 million Baycol prescriptions. What the Baycol recall revealed was that the company may have known about the serious rhabdomyolysis risks more than year a before adding a warning to its labels.
More than 100 deaths were linked to Baycol, and a review of published information and data obtained from internal company documents showed Bayer was aware of the drug’s risks earlier than stated. In response, Bayer said it closely watched Baycol’s safety after its approval, amending the drug’s label as evidence of adverse reactions became apparent.
Baycol had 20 times more reports of rhabdomyolysis per million prescriptions than another statin drug Lipitor. Both Bayer and the FDA were heavily criticized for allowing Baycol to remain on the market despite having information about rhabdomyolysis a year before the recall was issued. An FDA official, as a means of excusing the agency of the delayed Baycol ban, said, “We weren’t aware at that point of the difference between Baycol, and the other similar [drug]. Our expectation is when a company becomes aware of a specific problem with their drug, they come to us.”
When the Baycol recall was finally issued, 1,899 cases of rhabdomyolysis had been reported. Bayer said that as of April 25, 2005 it had paid $1.133 billion to settle 2,995 Baycol cases worldwide. The company said fewer than 6,000 Baycol cases were still pending. The Baycol recall has been used as a source of comparison for drug recalls in recent years. Just one example of a drug company withholding serious safety concerns, Baycol’s stay on the market jeopardized public health.
For more information on the Baycol recall and rhabdomyolysis, please contact us to confer with an attorney.