[HSF] FW: STS MEMBER ALERT: FDA Requests Marketing Suspension of Trasylol

[Ajit Damle]

Dear Colleague:

Following up on the STS member alert of October 26 regarding the FDA's
statement on the use of Aprotinin (Trasylol), please see the FDA notice
below which arrived today.

  _____  

FDA Notice

The U.S. Food and Drug Administration (FDA) today announced that, at the
agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing
suspension of Trasylol, a drug used to control bleeding during heart
surgery, pending detailed review of preliminary results from a Canadian
study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the
serious nature of the outcomes suggested in the preliminary data. For
additional information please visit
<http://www.magnetmail1.net/ls.cfm?r=102136340&sid=3017520&m=387453&u=TSTS&s
=http://www.fda.gov/bbs/topics/NEWS/2007/NEW01738.html>
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01738.html.  

FDA experts will hold a press briefing via teleconference on FDA's request
for market suspension of Trasylol. Healthcare professionals are invited to
participate in "listen-only" mode. Details on how to access the call are
below:

When: 
In order to accommodate international media and different time zones, there
are two opportunities to participate: Monday, November 5, 2007, 7:30 a.m.
and 11:45 a.m. 

How: 
7:30 a.m. EST Call-in information 
Toll-free:  888-603-9640 
Toll (International): 201-234-0018 
Passcode:  FDA

11:45 a.m. EST Call-in information 
Toll-free (U.S. and Canada): 888-677-5726 
Toll (International): 210-234-0028 
Passcode: FDA 

Who: 
FDA Center for Drug Evaluation and Research 
John K. Jenkins, MD, Director, Office of New Drugs 
Gerald Dal Pan, MD, Director, Office of Surveillance and Epidemiology 
Rafel Rieves, MD, Director, Office of Medical Imaging and Hematology 

Replays of each event will be available starting one hour after the event.
It can be heard by calling toll-free 866-467-2407 or toll 203-369-1444. If
you have questions, please free to contact the Office of Special Health
Issues at 301-827-4460.

Sincerely,


Brenda L. Evelyn, SBB (ASCP) 
Office of Special Health Issues  
U.S. Food and Drug Administration 
5600 Fishers Lane 
Rockville, MD  20857 
Phone: 301-827-4460  
E-mail:  <mailto:brenda.evelyn at fda.hhs.gov> brenda.evelyn at fda.hhs.gov   

Janelle Derbis, PharmD 
Office of Special Health Issues 
U.S. Food and Drug Administration 
20 N. Michigan Avenue 
Chicago, IL 60602 
Phone: 312-596-6516 
E-mail:  <mailto:Janelle.derbis at fda.hhs.gov> Janelle.derbis at fda.hhs.gov 

 

 

 


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