[HSF] Aprotinin

Michael Firstenberg msfirst at gmail.com
Sun Nov 19 19:20:18 EST 2006


do you have a link?

michael


On Nov 19, 2006, at 7:16 PM, Ben Bidstrup wrote:

> You might find it interesting to read the FDA transcript of the  
> Cardiovascular and Renal Advisory  Board 21 September.
>
>> Please don't disparage Dennis Mangano too much.  He is, or at  
>> least was, a
>> very capable clinical cardiac anesthesiologist and is fully  
>> cognizant of all
>> of the issues regarding intra-operative bleeding and post- 
>> operative care of
>> cardiac surgery patients.  That explains Dennis' consistent  
>> ability to focus
>> and publish provocatively on real life issues that confronting  
>> surgeons and
>> anesthesiologists on a day to day basis.  The methodology of his  
>> paper in
>> the NEJM is open to question.  Dr. Mangano's credentials are not!
>> Fraser Keith
>>
>> -----Original Message-----
>> From: openheart-l-bounces at lists.hsforum.com
>> [mailto:openheart-l-bounces at lists.hsforum.com] On Behalf Of Michael
>> Firstenberg
>> Sent: Sunday, November 19, 2006 10:18 AM
>> To: OpenHeart-L at lists.hsforum.com
>> Subject: Re: [HSF] Aprotinin
>>
>> If I recall Mangino is not a surgeon - in fact is he not an  
>> anesthesiologist, as are many of the people who recently write  
>> these articles about "bad cardiac drugs"?  Has he actually had to  
>> stand at the foot of a bed or in the OR for countless hours  
>> watching patient bleed to death and deal first hand with the  
>> consequences of massive transfusions.  Yes, renal failure and  
>> dialysis is bad bad bad - but compare that with right heart  
>> failure/ARDS/massive pressor requirements/etc from excessive  
>> bleeding (and the hypotension and associated ATN/renal failure  
>> anyhow).  My guess is he is home in bed all nice an cozy with his  
>> pager off at the end of his shift.
>>
>> -michael
>>
>>
>>
>>
>> On Nov 19, 2006, at 2:24 AM, Ani Anyanwu wrote:
>>
>>>  Prasanna
>>>
>>>  Well many would I suspect call it unbridled.
>>>
>>>  The following would generally receive aprotinin in my institution
>>>  1) reoperations
>>>  2) operations on the aortic arch or descending aorta
>>>  3) transplant and VAD procedures
>>>  4) operations on patients on clopidogrel
>>>  5) combined valvular and CABG
>>>  6) Patients with renal impairment
>>>  7) Patients where ability to tolerate transfusion or bleeding   
>>> complications is thought to be marginal including - most  
>>> patients  aged 70 or above, patients with severe lung disease,  
>>> poor LV  function, severe pulmonary hypertension, multiple  
>>> comorbidity etc.  Certainly almost all octogenrians would get  
>>> aprotinin - even for CABG.
>>>  8) Paradoxically, young patients in their 20s or 30s (where   
>>> avoidance of blood transfusion should be the goal in all patients)
>>>  9) Multiple valvular procedures (excluding tricuspid valve)
>>>  10) cases with anticipated bypass run more than 3 hours  
>>> (including  complex mitral repairs)
>>>
>>>  As you can see there is not much left - so maybe it is  
>>> unbridled!  As you implied we obviously would not use it for an  
>>> ASD or isolated  AVR, but these constitute a small minority of  
>>> our procedures.  Personally I would use it for practically every  
>>> operation -  including all CABGs - but that is a personal opinion  
>>> as I believe  there are non-hematological benefits of the drug  
>>> and like you
>>  > strongly believe in blood conservation. I do not have any  
>> interests
>>>  or links to industry.
>>>
>>>  Actually Ben brought up something that I had never thought of -   
>>> correct me if I am wrong but Aprotinin is the only agent  
>>> licensed  as a blood conservation agent for heart surgery?
>>>
>>>  Ani
>>>    ----- Original Message -----
>>>    From: psimha<mailto:prasannasimha at gmail.com>
>>>    To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-
>>>  L at lists.hsforum.com>
>>>    Sent: Sunday, November 19, 2006 12:00 AM
>>>    Subject: Re: [HSF] Aprotinin
>>>
>>>
>>>    Ani - are you really using it "unbridled" or liberally ? Do  
>>> you  use it
>>>    for an ASD or for a straight forward valve replacement ? or  
>>> any  other
>>>    case with a short bypass run ?
>>>    I did not say I will not use it in a redo - in fact if you  
>>> note my
>>>    original post I said I did use it in redo's ?
>>>    And Yes , I believe very strongly in blood conservation and   
>>> believe that
>>>    Aprotinin is one (and not the only ) cog in the wheel.
>>  >   Prasanna
>>>
>>>    Ani Anyanwu wrote:
>>>>  Prasanna
>>>>
>>>>  We use aprotinin in an unbridled way and are certainly yet to  
>>>> see  this price.
>>>>  - we have no more an incidence of renal failure than other   
>>>> institutions have (this we know because incidence of dialysis   
>>>> postop in all New York Hospitals is tracked by the State   
>>>> Department of Health)
>>>>  - we have no suggestion of an increase in early vein graft   
>>>> thrombosis (this should transform into higher periop MI and   
>>>> mortality, our CABG mortality rate has remained around 1.5% last  
>>>> 3  years)
>>>>  - we have not experienced any adverse events that caused us to  
>>>> be  concerned about its use, except fatal thrombosis in 2  
>>>> patients  with Factor V Lieden deficiency having circulatory  
>>>> arrest so we  now routinely screen for this defect in all  
>>>> circulatory arrest cases.
>>>>
>>>>  The price we are paying is a low incidence of transfusion of  
>>>> blood  products and a low re-exploration rate (<2% last 2 years  
>>>> even with  18% being redos and almost 20% aortic cases). Maybe  
>>>> there are  other unknown adverse effects which will catch up  
>>>> with us, but for  know they are unknown (and we wont be  
>>>> responsible; remember it is  the drug companies not doctors  
>>>> being sued for COX2 inhibitors).
>>>>
>>>>  Maybe when Mangano is bored he might do another study, and  
>>>> then  what will you do? For those who use Amicar, how do we  
>>>> really know  it is any safer - the drug is not even licensed for  
>>>> human use in  many European countries. Perhaps even his next  
>>>> study will be on  morbidity of plasma and platelet  
>>>> transfusions....then what will we  do?
>>>>
>>>>  Ani
>>>>    ----- Original Message -----
>>>>    From:   
>>>> prasannasimha<mailto:prasannasimha at gmail.com<mailto:prasannasimha at g 
>>>> ma
>>>>  il.com>>
>>>>    To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-
>>>>  L at lists.hsforum.com<mailto:OpenHeart-
>>>>  L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com>>
>>>>    Sent: Saturday, November 18, 2006 9:37 PM
>>>>    Subject: Re: [HSF] Aprotinin
>>>>
>>>>
>>>>    The thing I want to say is that be it Vioxx / Aprotinin/blood/
>>>>  Oxygen -
>>>>    they are all drugs and have effects and side effects. The   
>>>> present mess
>>>>    that the pharmacological companies are in is just because of  
>>>> their
>>>>    unbridled enthusiasm (or greed) to ,make a quick buck and it   
>>>> backfires
>>>>    on them. COX2 Inhibitors have a specific role unfortunately  
>>>> I  even saw
>>>>    my dentist prescribing it for tooth pain !! Who marketed it  
>>>> to  him as a
>>>>    good NSAID  ? I told him about the literature and my  
>>>> concerns  (this was
>>>>    prior to Vioxx) . They were trying to market Valdecoxib for  
>>>> post  cardiac
>>>>    surgery pain !!_ and I told them you should not be doing that  
>>>> -  but did
>>>>    they listen ? and bang in a few months a controversy breaks  
>>>> out.  The
>>>>    wife of colleague of mine was taking valdecoxib sample (she  
>>>> is a  Doctor
>>>>    too) as the sample was around and the premenopausal lady  
>>>> ended  up with a
>>>>    coronary thrombosis !!
>>>>    Every drug has a role and an indication based on good  
>>>> clinical  judgment
>>  >>   - unfortunately we pay the price when its use is unbridled.
>>>>    Prasanna
>>>>     
>>>> hgrmd at aol.com<mailto:hgrmd at aol.com<mailto:hgrmd at aol.com<mailto:hgrm 
>>>> d@
>>>>  aol.com>> wrote:
>>>>>  Prasanna and Ajit,
>>>>>    At the risk of great bodily harm from Ben, Ani, and others,  
>>>>> I  again think the use of aprotinin should be limited as much  
>>>>> as  possible.  I know there are cases where the benefit  
>>>>> seemingly  outweighs the risk.  However, the mounting  
>>>>> literature against it  is becoming increasingly compelling.  In  
>>>>> addition, my own  impression, made years before any of this  
>>>>> came out, was that the  drug increased the risk of ATN.  I'm  
>>>>> also convinced that this has  the potential to be the Vioxx of  
>>>>> cardiac surgery.  All I can say  is you guys who continue to  
>>>>> indiscriminantly use it have got some  really big ones.
>>>>>  Hal
>>>>>
>>>>>
>>>>>  -----Original Message-----
>>>>>  From:   
>>>>> prasannasimha at gmail.com<mailto:prasannasimha at gmail.com<mailto:pras 
>>>>> an
>>>>>  nasimha at gmail.com<mailto:prasannasimha at gmail.com>>
>>>>>  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-
>>  >>> L at lists.hsforum.com<mailto:OpenHeart-
>>>>>  L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com>>
>>>>>  Sent: Sat, 18 Nov 2006 1:00 PM
>>>>>  Subject: Re: [HSF] Aprotinin
>>>>>
>>>>>
>>>>>  Very Sorry used Aprotinin on my redo - can't help using it   
>>>>> selectively !!
>>>>>  Prasanna
>>>>>
>>>>>  Ajit Damle wrote:
>>>>>
>>>>>>  Journal club critique >
>>>>>>  A disheartening story: Aprotinin in cardiac surgery >
>>>>>>  Lien M, Milbrandt E
>>>>>>
>>>>>>  Critical Care, 2006 10:317 ( 8 November 2006 )
>>>>>>
>>>>>>
>>>>>>  Journal club critique
>>>>>>
>>>>>>
>>>>>>  A disheartening story: Aprotinin in cardiac surgery
>>>>>>
>>>>>>  Marcus Lien1 and Eric B Milbrandt2 >
>>>>>>  1Clinical Fellow, Department of Critical Care Medicine,   
>>>>>> University of
>>>>>>  Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA
>>>>>>
>>>>>>  2Assistant Professor, Department of Critical Care Medicine,   
>>>>>> University of
>>>>>>  Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA
>>>>>>
>>>>>>
>>>>>>  Critical Care 2006, 10:317 doi:10.1186/cc5072
>>>>>>
>>>>>>
>>>>>>>
>>>>>>>
>>>>>>  Evidence based medicine journal club critique edited by E B   
>>>>>> Milbrant
>>>>>>
>>>>>>
>>>>>>  The electronic version of this article is the complete one  
>>>>>> and  can be found
>>>>>>  online at: http://ccforum.com/content/10/6/317<http://
>>>>>>  ccforum.com/content/10/6/317<http://ccforum.com/content/
>>>>>>  10/6/317<http://ccforum.com/content/10/6/317>>
>>>>>>
>>>>>>
>>>>>>  Published 8 November 2006 >
>>>>>>
>>>>>>  C 2006 BioMed Central Ltd
>>>>>>
>>>>>>  Citation
>>>>>>
>>>>>>  Mangano DT, Tudor IC, Dietzel C: The risk associated with   
>>>>>> aprotinin in
>>>>>>  cardiac surgery. N Engl J Med 2006, 354:353-365 [1].
>>>>>>
>>>>>>
>>>>>>  Background
>>>>>>
>>>>>>
>>>>>>  The majority of patients undergoing surgical treatment for ST-
>>>>>>  elevation
>>>>>>  myocardial infarction receive antifibrinolytic therapy to  
>>>>>> limit  blood loss.
>>>>>>  This approach appears counterintuitive to the accepted  
>>>>>> medical  treatment of
>>>>>>  the same condition - namely, fibrinolysis to limit  
>>>>>> thrombosis.  Despite this
>>>>>>  concern, no independent, large-scale safety assessment has  
>>>>>> been  undertaken.
>>>>>>
>>>>>>
>>>>>>  Methods
>>>>>>
>>>>>>
>>>>>>  Design and setting
>>>>>>
>>>>>>
>>>>>>  Prospective observational cohort study in 69 institutions in   
>>>>>> North and South
>>>>>>  America, the Middle East, Europe, and Asia.
>>>>>>
>>>>>>
>>>>>>  Subjects
>>>>>>
>>>>>>
>>>>>>  4374 patients undergoing coronary-artery revascularization.  
>>>>>> All  patients
>>>>>>  were >18 years old and completed a pre-surgery interview.   
>>>>>> Patients were
>>>>>>  classified as undergoing primary surgery (no previous heart   
>>>>>> surgery and no
>>>>>>  other surgery besides a coronary artery bypass graft), or   
>>>>>> complex surgery
>>>>>>  (all other surgery).
>>>>>>
>>>>>>
>>>>>>  Intervention
>>>>>>
>>>>>>
>>>>>>  None.
>>>>>>
>>>>>>
>>>>>>  Measurements
>>>>>>
>>>>>>
>>>>>>  The authors prospectively assessed three agents (aprotinin  
>>>>>> [1295  patients],
>>>>>>  aminocaproic acid [883], and tranexamic acid [822]) as  
>>>>>> compared  with no
>>>>>>  agent (1374 patients) with regard to serious cardiovascular,
>>  >>>> renal, and
>>>>>>  cerebrovascular outcomes by propensity and multivariable  
>>>>>> methods.
>>>>>>
>>>>>>
>>>>>>  Results
>>>>>>
>>>>>>
>>>>>>  In propensity-adjusted, multivariable logistic regression (C-
>>>>>>  index, 0.72),
>>>>>>  use of aprotinin was associated with a doubling in the risk  
>>>>>> of  renal failure
>>>>>>  requiring dialysis among patients undergoing complex coronary-
>>>>>>  artery surgery
>>>>>>  (odds ratio, 2.59; 95 percent confidence interval, 1.36 to  
>>>>>> 4.95)  or primary
>>>>>>  surgery (odds ratio, 2.34; 95 percent confidence interval,  
>>>>>> 1.27  to 4.31).
>>>>>>  Similarly, use of aprotinin in the latter group was  
>>>>>> associated  with a 55
>>>>>>  percent increase in the risk of myocardial infarction or  
>>>>>> heart  failure (P <
>>>>>>  0.001) and a 181 percent increase in the risk of stroke or   
>>>>>> encephalopathy (P
>>>>>>  = 0.001). Neither aminocaproic acid nor tranexamic acid was   
>>>>>> associated with
>>>>>>  an increased risk of renal, cardiac, or cerebral events.  
>>>>>> Adjustment
>>>>>>  according to propensity score for the use of any one of the   
>>>>>> three agents as
>>>>>>  compared with no agent yielded nearly identical findings. All
>>  >>>> the agents
>>>>>>  reduced blood loss.
>>>>>>
>>>>>>
>>>>>>  Conclusion
>>>>>>
>>>>>>
>>>>>>  The association between aprotinin and serious end-organ  
>>>>>> damage  indicates
>>>>>>  that continued use is not prudent. In contrast, the less   
>>>>>> expensive generic
>>>>>>  medications aminocaproic acid and tranexamic acid are safe   
>>>>>> alternatives.
>>>>>>
>>>>>>
>>>>>>>
>>>>>>  The medical and surgical approaches to acute ST-elevation   
>>>>>> myocardial
>>>>>>  infarction present an interesting paradox. The medical  
>>>>>> approach  focuses on
>>>>>>  fibrinolytic therapy. Due to concerns over bleeding, the   
>>>>>> surgical approach
>>>>>>  avoids fibrinolytic agents and instead uses agents that  
>>>>>> mitigate  bleeding,
>>>>>>  so called antifibrinolytic agents, which include aprotinin,   
>>>>>> aminocaproic
>>>>>>  acid, and tranexamic acid. These agents were generally   
>>>>>> considered safe based
>>>>>>  on a number of secondary analyses of studies that were not   
>>>>>> primarily
>>>>>>  intended to assess safety. These relatively small studies  
>>>>>> were  underpowered
>>>>>>  to detect adverse events and did not involve head-to-head   
>>>>>> comparisons of the
>>>>>>  commonly used antifibrinolytic agents. Animal studies  
>>>>>> suggest  that these
>>>>>>  agents have the potential to cause ischemic damage to  
>>>>>> multiple  organ systems
>>>>>>  and small, largely single-center studies have suggested   
>>>>>> increased graft
>>>>>>  thrombosis and renal dysfunction [2-6]. Ideally, the safety  
>>>>>> of  these agents
>>>>>>  would be compared in a large, multi-center, randomized   
>>>>>> controlled trial.
>>>>>>  However, because their use is embedded in practice and  
>>>>>> because  regulatory
>>>>>>  approval of these agents differs by country, conducting such  
>>>>>> a  trial will be
>>>>>>  difficult if not impossible.
>>>>>>
>>>>>>
>>>>>>  To address the safety of these agents for cardiopulmonary  
>>>>>> bypass  surgery,
>>>>>>  Mangano and colleagues [1] conducted a large, prospective,   
>>>>>> observational
>>>>>>  cohort assessing aprotinin, aminocaproic acid, and  
>>>>>> tranexamic  acid as
>>>>>>  compared to no agent in 4374 patients undergoing   
>>>>>> revascularization. Because
>>>>>>  this was a prospective study, the authors were able to  
>>>>>> collect a  wealth of
>>>>>>  clinical information, including approximately 7500 data  
>>>>>> fields  per patient.
>>>>>>  This permitted consideration of variables that might  
>>>>>> influence  both choice
>>>>>>  of antifibrinolytic agent and clinical outcome. The authors  
>>>>>> used a
>>>>>>  propensity score based on 45 treatment-selection covariates and
>>>>>>  multivariable modeling to control for baseline differences   
>>>>>> between groups.
>>>>>>  In doing so, they found that aprotinin, but not aminocaproic   
>>>>>> acid or
>>>>>>  tranexamic acid, was associated with serious cardiovascular,   
>>>>>> renal, and
>>>>>>  cerebrovascular adverse events. Furthermore, a dose-response   
>>>>>> relationship
>>>>>>  was demonstrated, strengthening the inference of causality.
>>>>>>
>>>>>>
>>>>>>  The main weakness of this study is that the authors failed to
>>  >>>> report details
>>>>>>  of the surgery itself, such as whether the surgery was on  
>>>>>> vs.  off-pump, time
>>>>>>  on pump, and number of vessels bypassed. These variables are   
>>>>>> likely to
>>>>>>  influence not only choice of antifibrinolytic agent but also   
>>>>>> outcome, and
>>>>>>  are, therefore, a source of indication bias that could  
>>>>>> reflect  unfavorably
>>>>>>  on aprotinin.
>>>>>>
>>>>>>
>>>>>>  Based on the results of this study and those of another   
>>>>>> observational study
>>>>>>  suggesting renal toxicity [7], the United States Food and Drug
>>>>>>  Administration (FDA) held an advisory committee meeting   
>>>>>> September 21, 2006
>>>>>>  to consider the cardiovascular safety of aprotinin. Because  
>>>>>> of  concerns
>>>>>>  about the methodology of the study by Mangano and colleagues  
>>>>>> and  because it
>>>>>>  was the only study to suggest cardiovascular adverse events  
>>>>>> [8],  the
>>>>>>  advisory committee concluded that there was insufficient   
>>>>>> evidence to support
>>>>>>  changing the cardiovascular safety labeling of the drug.   
>>>>>> However, just six
>>>>>>  days after the committee met, it was revealed that the  
>>>>>> drug's  manufacturer,
>>  >>>> Bayer, had preliminary results from an observational study of
>>>>>>  67,000 cardiac
>>>>>>  bypass patients that suggested aprotinin was associated with   
>>>>>> increased risk
>>>>>>  of death, renal dysfunction, congestive heart failure, and   
>>>>>> stroke [9]. The
>>>>>>  FDA subsequently issued a statement indicating it was unaware  
>>>>>> of  this study
>>>>>>  when the advisory committee met and that it is evaluating  
>>>>>> the  results of
>>>>>>  this study and the potential implications for the use of   
>>>>>> aprotinin [10]. In
>>>>>>  the mean time, the FDA suggests that physicians who use   
>>>>>> aprotinin should
>>>>>>  carefully monitor patients for the occurrence of toxicity,   
>>>>>> particularly to
>>>>>>  the kidneys, heart, or brain, and promptly report observed   
>>>>>> adverse events.
>>>>>>  They go on to recommend that physicians should consider  
>>>>>> limiting  aprotinin
>>>>>>  use to those situations where the clinical benefit of  
>>>>>> reduced  blood loss is
>>>>>>  essential to medical management of the patient and outweighs  
>>>>>> the  potential
>>>>>>  risks.
>>>>>>
>>>>>>
>>>>>>  Recommendation >
>>>>>>
>>>>>>  The weight of evidence suggests that aprotinin increases the   
>>>>>> risk for a poor
>>>>>>  outcome among patients undergoing cardiac operations. Not  
>>>>>> only  is this drug
>>>>>>  very expensive, it seems to be toxic. Although the risk of   
>>>>>> excessive
>>>>>>  bleeding is certainly a cause for concern in certain  
>>>>>> patients,  and treatment
>>>>>>  with aprotinin can decrease blood loss in selected patients,   
>>>>>> data are
>>>>>>  lacking to show that administration of this agent actually  
>>>>>> improves
>>>>>>  survival.
>>>>>>
>>>>>>
>>>>>>  Competing interests
>>>>>>
>>>>>>  The authors declare that they have no competing interests.
>>>>>>
>>>>>>
>>>>>>>
>>>>>>  1. Mangano DT, Tudor IC, Dietzel C: The risk associated with   
>>>>>> aprotinin in
>>>>>>  cardiac surgery.
>>>>>>
>>>>>>  N Engl J Med 2006, 354:353-365. >
>>>>>>
>>>>>>  2. Cosgrove DM III, Heric B, Lytle BW, Taylor PC, Novoa R,   
>>>>>> Golding LA,
>>>>>>  Stewart RW, McCarthy PM, Loop FD: Aprotinin therapy for  
>>>>>> reoperative
>>>>>>  myocardial revascularization: a placebo-controlled study.
>>>>>>
>>>>>>  Ann Thorac Surg 1992, 54:1031-1036.
>>>>>>
>>>>>>
>>>>>>  3. D'Ambra MN, Akins CW, Blackstone EH, Bonney SL, Cohn LH,   
>>>>>> Cosgrove DM,
>>>>>>  Levy JH, Lynch KE, Maddi R: Aprotinin in primary valve   
>>>>>> replacement and
>>>>>>  reconstruction: a multicenter, double-blind, placebo- 
>>>>>> controlled  trial.
>>>>>>
>>>>>>  J Thorac Cardiovasc Surg 1996, 112:1081-1089
>>>>>>
>>>>>>
>>>>>>  4. Feindt PR, Walcher S, Volkmer I, Keller HE, Straub U,  
>>>>>> Huwer  H, Seyfert
>>>>>>  UT, Petzold T, Gams E: Effects of high-dose aprotinin on  
>>>>>> renal  function in
>>>>>>  aortocoronary bypass grafting.
>>>>>>
>>>>>>  Ann Thorac Surg 1995, 60:1076-1080 >
>>>>>>
>>>>>>  5. Sundt TM III, Kouchoukos NT, Saffitz JE, Murphy SF,  
>>>>>> Wareing  TH, Stahl
>>>>>>  DJ: Renal dysfunction and intravascular coagulation with   
>>>>>> aprotinin and
>>>>>>  hypothermic circulatory arrest.
>>  >>>>
>>>>>>  Ann Thorac Surg 1993, 55:1418-1424 >
>>>>>>
>>>>>>  6. Umbrain V, Christiaens F, Camu F: Intraoperative coronary   
>>>>>> thrombosis:
>>>>>>  can aprotinin and protamine be incriminated?
>>>>>>
>>>>>>  J Cardiothorac Vasc Anesth 1994, 8:198-201 >
>>>>>>
>>>>>>  7. Karkouti K, Beattie WS, Dattilo KM, McCluskey SA, Ghannam  
>>>>>> M,  Hamdy A,
>>>>>>  Wijeysundera DN, Fedorko L, Yau TM: A propensity score case- 
>>>>>> control
>>>>>>  comparison of aprotinin and tranexamic acid in high-transfusion-
>>>>>>  risk cardiac
>>>>>>  surgery.
>>>>>>
>>>>>>  Transfusion 2006, 46:327-338 >
>>>>>>
>>>>>>  8. Hughes S: Aprotinin safety again in spotlight as new  
>>>>>> study  suggests
>>>>>>  increased cardiac events.
>>>>>>
>>>>>>  http://www.medscape.com/viewarticle/545400<http://
>>>>>>  www.medscape.com/viewarticle/545400<http://www.medscape.com/
>>>>>>  viewarticle/545400<http://www.medscape.com/viewarticle/ 
>>>>>> 545400>> >
>>>>>>  October 2, 2006 >
>>>>>>  9. Harris G: FDA says Bayer failed to reveal drug risk study.
>>>>>>
>>>>>>  [http://www.nytimes.com/2006/09/30/health/30fda.html] New  
>>>>>> York  Times >
>>>>>>
>>>>>>  10. US Food and Drug Administration: FDA Public Health  
>>>>>> Advisory:  Aprotinin
>>>>>>  Injection (marketed as Trasylol).
>>>>>>
>>>>>>  [http://www.fda.gov/cder/drug/advisory/aprotinin20060929.htm] >
>>  >>>> September 29, 2006 >
>>>>>>
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>>
>> _______________________________________________
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>> -----------------------------------------
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>> _______________________________________________
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>
>
> -- 
> Ben Bidstrup FRACS FRCSEd FEBCTS
> Consultant Cardiothoracic Surgeon
> _______________________________________________
> OpenHeart-L mailing list
>
> Send postings to:
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>
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> 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
> -----------------------------------------



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