Tuesday, January 23, 2007
Texans deserve to be fully informed about the adverse effects of their medications, said Attorney General Abbott. This agreement ensures that patients have access to the information they need to make educated health care decisions.
The terms of the judgment require that Bayer register its clinical studies and, upon the completion of each study, post the results on the Internet. The marketing, sale and promotion of Bayer’s pharmaceutical and biological products must comply with the law and cannot include false or misleading claims.
In 1997 the U.S. Food and Drug Administration approved Baycol, a statin cholesterol-lowering prescription drug, which Bayer began marketing to the medical community in May 1998. While patients who take statin drugs frequently experience muscle-weakening side effects, Bayer failed to disclose that its product posed significantly greater risks than did statins produced by other drug companies. Additionally, Bayer did not reveal that the muscle-weakening effects were particularly acute among those patients who were also taking other statin drugs.
Because of Bayer’s failure to disclose risks exacerbated by its product, patients who were prescribed Baycol were not informed of its potential side effects. Concealing risks in the name of profit violates the Texas Deceptive Trade Practices Act.