I guess no more Aprotinin

[urge]

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Bayer Temporarily Suspends Global Trasylol® Marketing​

Leverkusen, Germany and West Haven, CT, USA – November 5, 2007 -- [FONT=Times New Roman,Times New Roman]Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol® (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients. .
[FONT=Times New Roman,Times New Roman].
[FONT=Times New Roman,Times New Roman]www.trasylol.com.
[FONT=Times New Roman,Times New Roman].
[FONT=Times New Roman,Times New Roman]Just curious, who used it today?
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[coprolalia]

Marketing? As in, they won't advertise or detail it? Or, availability? In that you can't get it anymore?

Cardiac cases will only be done with Amicar now, I suppose. No one will want to touch Trasylol with a 10-ft pole until this trial is done.

-copro

 

[urge]

marketing- as in not being sold anymore.

"Until these issues are resolved Bayer has temporarily suspended marketing of Trasylol and halted all shipments on a world-wide basis."

"This action follows notification to Bayer and regulatory authorities that the BART Executive Committee had halted the trial after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Bayer has been informed that data are now being collected from centers throughout Canada and a final data analysis will be undertaken by BART investigators -- a process that is expected to take up to eight weeks, or perhaps longer."

Trial was halted. They need to re evaluate data. I'm sure results will be the same once analyzed further.

Aprotinin R.I.P. 11/5/07

 

[coprolalia]

Yikes! Amicar it is. (Personally never used tranxenamic acid before... it has always been Amicar or Trasylol for our pump cases.)

-copro