Tuesday, September 11, 2007

FDA Panel: Trasylol Hearing 9/12

An advisory panel of the FDA takes another look at the safety of Trasylol on Wednesday, just after new data came just days after another FDA advisory panel met last year over the drug's safety.

That first advisory panel found that Trasylol, used to stem bleeding and the need for blood transfusions during surgery, was acceptable for some patients undergoing heart surgery.

According to Reuters, the FDA staffers wrote that the totality of three recent studies support the risk of renal failure and dysfunction, and noted a "mortality disadvantage detected" in one Bayer study. Link.

The FDA may conclude that indeed the drug increases the risk of kidney failure and death. In my view, however, patients may not even be aware they were injected with Trasylol during heart surgery. To be truly practical, the FDA should require any hospital patients who were given Trasylol to be informed by letter from the medical provider who may have had it injected.