Bayer pulls Trasylol at FDA request

Bayer may not have owned up to adverse data on Trasylol before, but it is now--or at least it's prepared to say "maybe." The company is withdrawing the anti-clotting drug at the FDA's request, the agency says, after preliminary data from a new study showed Trasylol increased the risk of death.

Canadian researchers halted the Trasylol portion of their study, which focuses on high-risk heart surgery patients, when a periodic analysis of their data picked up the problems. They'll now sift through the data for more on Trasylol, a process that's likely to take eight weeks or more.

Bayer calls the data "limited and preliminary" and says that it thinks the drug still has a "favorable risk-benefit profile." We'll have to wait until regulators get a look-see at the trial before we know for sure.

- see the release from Bayer
- check out the FDA release
- read the report from the Associated Press

Related Articles:
FDA to revisit Trasylol death risk. Report
Bayer's Trasylol stays on the market. Report
Bayer braces for looming Trasylol review. Report
Investigator: Bayer did not hide Trasylol data. Report
Bayer kept Trasylol safety study hidden from FDA. Report

Suggested Articles

Pfizer isn't giving up in biosims. This week, it unveiled launches to three Roche blockbusters, with two already on the market.

Novo Nordisk is betting big on GLP-1 Saxenda in its global obesity push, but England's cost watchdog is unimpressed with the drug's long-term outlook.

Tecentriq didn’t show benefit against simple observation at delaying cancer recurrence or death in patients with muscle-invasive urothelial cancer.