Aprotinin - Are there lessons learned?

JAMA

Volumn 297, Issue 5, 2007, Pages 527-529

  Ferguson, T Bruce ^a,b  

^a EAST CAROLINA UNIVERSITY   (United States)

^b Division of Cardiothoracic and Vascular Surgery   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOCAPROIC ACID; ANTIFIBRINOLYTIC AGENT; ANTIPARKINSON AGENT; APROTININ; CYCLOOXYGENASE 2 INHIBITOR; TRANEXAMIC ACID;

ACUTE KIDNEY FAILURE; BLEEDING; BRAIN DISEASE; CORONARY ARTERY BYPASS GRAFT; DRUG EFFICACY; DRUG ELUTING STENT; DRUG SAFETY; EDITORIAL; HEART INFARCTION; HEART SURGERY; HUMAN; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SIDE EFFECT; STROKE; SURGICAL MORTALITY; THROMBOSIS;

EID: 33846871010     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.297.5.527     Document Type: Editorial

References (21)

1. US Food and Drug Administration. Approval of aprotinin [press release p93-48], December 30, 1993. http://www.fda.gov/bbs/topics/NEWS/NEW00453.html. Accessed January 9, 2007.
2. Mangano DT, Miao Y, Vuylsteke A; Investigators of the Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA. 2007;297:471-479.
3. D'Agostino RB Jr. Propensity score methods for bias reduction in the comparision of a treatment to a non-randomized control group. Stat Med. 1998;17:2265-2281.
4. Byar DP. Problems with using observational databases to compare treatments. Stat Med. 1991;10:663-666.
5. Alderman EL, Levy JH, Rich JB. Analyses of coronary graft patency after aprotinin use: results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial. J Thorac Cardiovasc Surg. 1998;116:716-730.
6. Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia (McSPI) Research Group; Ischemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006;354:353-365.
7. Ferraris VA, Bridges CR, Anderson RP; Blood Conservation Guideline Taskforce of the Society of Thoracic Surgeons. Aprotinin in cardiac surgery [letter to the editor/reply]. N Engl J Med. 2006;354:1953-1957.
8. US Food and Drug Administration Center for Drug Evaluation and Research. Trasylol medical officer review (application 020304/S004), adminstrative documents/correspondence (part 2, pages 4, 5, 6, January 3, 1997). http://www.fda.gov/cder/foi/nda/98/020304s004.htm. Accessed January 16, 2007.
9. Hunter D. First, gather the data. N Engl J Med. 2006;354:329-331.
10. Peterson ED, Coombs LP, Haan CK, De Long ER, Ferguson TB Jr. Procedural volume as a marker of quality for CABG surgery. JAMA. 2004;291:195-201.
11. DeLong ER, Coombs LP, Ferguson TB Jr, Peterson ED. The evaluation of treatment when center-specific selection criteria vary with respect to patient risk. Biometrics. 2005;61:942-949.
12. Levy JH, Ramsay JG, Guyton RA. Aprotinin in cardiac surgery [letter to the editor/reply]. N Engl J Med. 2006;354:1953-1957.
13. Cosgrove DM, Heric B, Lytle BW, et al. Aprotinin therapy for reoperative myocardial revascularization: a placebo-controlled study. Ann Thorac Surg. 1992;54:1031-1038.
14. Saffitz JE, Stahl DJ, Sundt TM, Wareing TH, Kouchoukos NT. Disseminated intravascular coagulation after administration of aprotinin in combination with deep hypothermic circulatory arrest. Am J Cardiol. 1993;72:1080-1082.
15. Westaby S, Katsumata T. Aprotinin and vein graft occlusion: the controversy continues. J Thorac Cardiovasc Surg. 1998;116:731-733.
16. US Food and Drug Administration. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies. Fed Regist. 2006;71:10978-10979.
17. Boston Scientific Corporation. Resources for healthcare professionals, FDA statement on coronary drug-eluting stents presented by Donald S. Baim, MD, December 7th and 8th, 2006. http://www.taxus-stent.com/usa/hcp.html?clickType= ts_us_hcp. Accessed January 10, 2007.
18. "Real world" use of the CYPHER sirolimus-eluting stent presentated by Sidney A Cohen, MD, to the FDA, December 7th and 8th, 2006. US Food and Drug Administration Web site. http://www.fda.gov/ohrms/dockets/ac/06/ slides/2006-4253oph1_14_cohen-cordis.pdf. Accessed January 9, 2007.
19. Relative merits and clinical selection of CABG, bare metal stents, and drug-eluting stents in practice and in evolution, presentation by Peter K. Smith, MD. US Food and Drug Administration Web site. http://www.fda.gov/ohrms/ dockets/ac/06/slides/2006-4253oph2_11_smith.pdf. Accessed January 8, 2007.
20. Overview for panel packet: DES thrombosis panel. US Food and Drug Administration Web site. http://www.fda.gov/ohms/dockets/ac/06/briefing/2006- 4253b_01.pdf. Accessed January 16, 2007.
21. US Food and Drug Administration. FDA alert P06-203: FDA revises labeling for Trasylol (aprotinin injection) to strengthen safety warnings and limit usage of drug to specific situations, December 15, 2006. http://www.fda.gov/bbs/ topics/NEWS/2006/NEW01529.html. Accessed January 8, 2007.