FDA To Review Trasylol Safety - Again
1 CommentBy Ed Silverman // August 22nd, 2007 // 12:37 pm
In the aftermath of Bayer’s embarssing cover-up, the agency has scheduled a Sept. 12 meeting to look at data suggesting the blood Trasylol can cause kidney damage, heart failure and even death, according to a posting on the FDA’s web site.
The FDA already held a similar meeting last September, but then a scandal emerged: A few days after the meeting, Bayer disclosed that two employees withheld info about Trasylol’s side effects. Bayer condemned the decision and last week insisted the cover-up wasn’t a cover-up - an outside investigation concluded the employees didn’t intend to mislead regulators.
Nonetheless, the FDA late last year added warnings that Trasylol, which is used to reduce blood loss during bypass procedures, should only be used in patients who have an elevated risk of blood loss during surgery. Any further restrictions would be a blow to Bayer. Trasylol sales last year fell 33 percent to $195 million.
Tom Lamb
One has to wonder about the timing of this latest FDA Avandia announcement.
As observed at Drug Injury Watch:
“Coincidentally, or ironically, Bayer announced just last week that an outside investigation had concluded these two employees did not intend to mislead the FDA’s earlier advisory committee members by withholding that Trasylol side effect information.”