Here’s more sobering news about Bayer’s drug, which is used to stop bleeding during cardiac surgery: it raises the risk of death by nearly 50 percent five years after being administered, and using cheaper meds would save some 10,000 lives worldwide over the next five years.

This is only the latest blow to Bayer and its drug. The same scientists who published the study in the latest issue of the Journal of the American Medical Association last year found Trasylol was linked to a higher risk of kidney failure, heart attacks and strokes. The earlier findings prompted the FDA to hold a September meeting to review Trasylol. But Bayer failed to provide retrospective data showing a higher risk of death and stroke, even though its own scientists attended the meeting. The internal data was disclosed several days after the meeting.

The JAMA study underscores disturbing questions about safety and regulatory follow-up, because Trasylol was approved by the FDA in 1993. “We don’t know enough about what happens with drugs and devices once they go into the public domain,” Bruce Ferguson of East Carolina University told the Associated Press. He wrote an editorial accompanying the study. Drugmakers will have to help pay for a better system of post-market research because the government can’t afford to do it alone, he said.

In a statement, Bayer came off as defensive and argumentative. The drugmaker pooh-poohed the JAMA study, pointed out various limitations and promised to evaluate the findings. The only mention of patient safety was brief, and didn’t appear until the last paragraph.

[tags]Bayer, FDA, JAMA, Trasylol[/tags]