A comparison of results of the us food and drug administration's mini-sentinel program with randomized clinical trials: The case of gastrointestinal tract bleeding with dabigatran

JAMA Internal Medicine

Volumn 174, Issue 1, 2014, Pages 150-151

  Sipahi, Ilke ^a,b   Celik, Seden ^a   Tozun, Nurdan ^a  

^a ACIBADEM UNIVERSITY   (Turkey)

^b UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; WARFARIN;

CLINICAL TRIAL; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL HEMORRHAGE; HUMAN; LETTER; PRIORITY JOURNAL; PRODUCT SAFETY;

ANTICOAGULANTS; ANTITHROMBINS; BENZIMIDAZOLES; BETA-ALANINE; DATABASES, PHARMACEUTICAL; GASTROINTESTINAL HEMORRHAGE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WARFARIN;

EID: 84892401966     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2013.12217     Document Type: Letter

References (6)

1. Southworth MR, Reichman ME, Unger EF Dabigatran and postmarketing reports of bleeding. N Engl J Med. 2013;368(14):1272-1274.
2. Connolly SJ, Ezekowitz MD, Yusuf S, et al.; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.
3. Schulman S, Kearon C, Kakkar A.K., et al.; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24):2342-2352.
4. Schulman S, Kearon C, Kakkar A.K., et al.; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013;368(8):709-718.
5. Boehringer Ingelheim Dabigatran Advisory Committee briefing document 2010. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM226009.pdf. Accessed July 2013.
6. Boehringer Ingelheim trial No.1160.46 synopsis. 2011. http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/ com-EN/results/1160/1160.46-U11-2298-01.pdf. Accessed July 2013.