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
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