[HSF] Fwd: STS MEMBER ALERT: FDA Issues Statement onUseofAprotinin (Tra...

[Tony Furnary]

Rob, I share your feelings and concern.  I feel it would be a travesty (to quote SB -- God rest his soul) for the FDA to force such a withdrawal based on the faulty NEJM study (lacking numerical transfusion data) produced to serve the obvious negative conflict of interest that Magnano has against Bayer.

Tony


-----Original Message-----
From:	rsboova at comcast.net [mailto:rsboova at comcast.net]
Sent:	Mon 10/29/2007 5:06 AM
To:	OpenHeart-L at lists.hsforum.com
Cc:	
Subject:	RE: [HSF] Fwd: STS MEMBER ALERT: FDA Issues Statement onUseofAprotinin (Tra...

Tony - in that most of the patients requiring CPB are advanced risk patients , I have found aprotinin to be a valuable adjunct and believe it reduces perioperative bleeding. The risks of transfusions are well documented so resolving the immediate as well as long term risk benefit ratio for the drug use versus the transfusions will perhaps  require a detailed longitudinal study . I am concerned that the manufacturer will withdraw the drug from the market . Relegating us  to previous mechanisms for blood conservation.  Rob 

-------------- Original message -------------- 
From: "Tony Furnary" <tfurnary at starrwood.com> 

> Note from the press release: "the use of aprotinin was associated with less 
> serious bleeding than either of the comparator drugs; however, more deaths due 
> to hemorrhage had been observed among patients receiving aprotinin" 
> 
> Aprotinin was never designed to eliminate massive surgical hemmorrhage. eg-- 
> the use of aprotinin does not preclude one from completing suture lines with 
> skill, nor does it prevent one from sawing into the RV on a Redo. 
> 
> one shouiild not pre-judge (with prejudice) the final results of the study 
> through a quick scan of a press release by the FDA. The same thing happened 
> with renal failure. Not saying that is is not true ... just saying we should 
> wait to look at the final analysis of the data. 
> 
> Tony 
> PS -- Members should know that I've got [sic] absolutely no financial interest 
> one way or the other in regards to aprotinin. 
> 
> 
> -----Original Message----- 
> From: Hgrmd at aol.com [mailto:Hgrmd at aol.com] 
> Sent: Sat 10/27/2007 6:15 AM 
> To: OpenHeart-L at lists.hsforum.com 
> Cc: 
> Subject: Re: [HSF] Fwd: STS MEMBER ALERT: FDA Issues Statement on 
> UseofAprotinin (Tra... 
> 
> Claudia, 
> It may be a "nice" drug, but it sure is getting an increasingly dangerous 
> reputation. The FDA site is _http://www.fda.gov/cder/drug/early_ 
> (http://www.fda.gov/cder/drug/early) comm/aprotinin.htm. Members should know 
> that I've 
> got absolutely no financial interest one way or the other in regards to 
> aprotinin. However, I believe its use should be limited to dialysis patients 
> or 
> patients undergoing major aortic reconstructions. 
> 
> Hal 
> 
> 
> 
> ************************************** See what's new at http://www.aol.com 
> _______________________________________________ 
> OpenHeart-L mailing list 
> 
> Send postings to: 
> OpenHeart-L at lists.hsforum.com 
> 
> To UNSUBSCRIBE, to CHANGE email address, or to view archives: 
> http://mmp.cjp.com/mailman/listinfo/openheart-l 
> 
> All messages transmitted by the OpenHeart-L are subject to the policies and 
> disclaimers posted at: 
> http://www.hsforum.com/listdisclaim 
> ----------------------------------------- 
> 
> 
> 
>