Bayer's Trasylol raises kidney risk: FDA regulators

Share this article:

FDA regulators said that Bayer's injectable Trasylol, used to control bleeding in bypass surgery, raised the risk of kidney damage in clinical studies and may also increase the chance of death in patients.

The findings may require restrictions on the use of Trasylol or new clinical trials, according to a posting to the FDA's Web site.

A panel of heart and kidney disease experts is scheduled to consider the information on Trasylol when it meets on Sept. 12.

The FDA held a similar meeting concerning the drug last September after which Bayer said two employees decided to withhold additional information about Trasylol's side effects. The information not provided by Bayer showed that patients on Trasylol had a higher risk of death, kidney failure, congestive heart failure and stroke, the FDA said.

Bayer said last week that an outside investigation concluded the employees did not intend to mislead regulators.

Bayer said in a published report that it has since revamped how it handles drug studies. Meanwhile, the two employees, based in Germany, were suspended for failing to inform supervisors that the study was completed, a spokeswoman for the company told

Annual sales of Trasylol fell 33% to $195 million in 2006 compared with the year earlier period.


Share this article:

Email Newsletters

More in News

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on ...

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.