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

Mylan and Pfizer's Upjohn have a name for their pending merger: Viatris. Heard that before? So has Mylan, which owns a subsidiary with the same name.

Intercept presented a data analysis that found treatment with Ocaliva led to "early and consistent improvements" in a range of noninvasive tests.

Days before Amarin faces a pivotal FDA vote on its Vascepa expansion, advisors are set to scrutinize the placebo used in its pivotal outcomes trial.