Rivaroxaban: Can we trust the evidence?

BMJ (Online)

Volumn 352, Issue , 2016, Pages

  Cohen, Deborah ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

RIVAROXABAN; WARFARIN; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 10A INHIBITOR;

ATRIAL FIBRILLATION; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; EMBOLISM; EUROPE; HUMAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RISK ASSESSMENT; SHORT SURVEY; UNITED STATES; COMPLICATION; DEVICES; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; INTERNATIONAL NORMALIZED RATIO; STANDARDS; STROKE;

ANTICOAGULANTS; ATRIAL FIBRILLATION; BRAIN ISCHEMIA; DRUG APPROVAL; EMBOLISM; EUROPE; EVIDENCE-BASED MEDICINE; FACTOR XA INHIBITORS; HUMANS; INTERNATIONAL NORMALIZED RATIO; RIVAROXABAN; STROKE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WARFARIN;

EID: 84959293247     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.i575     Document Type: Short Survey

References (14)

1. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-91.
2. Top 50 pharmaceutical products by global sales. www.pmlive.com/top-pharma-list/Top-50-pharmaceutical-products-by-global-sales.
3. Cohen D. Concerns over data in key dabigatran trial. BMJ 2014;349:g4670.
4. Burger l. Trial for Bayer drug Xarelto under scrutiny over defective device. Reuters 2015 Dec 9.www.reuters.com/article/us-bayer-xarelto-idUSKBN0TR2DU20151209#c4qYKB7bEseov2Fl.97.
5. FDA. Drug approval package Xarelto. 2015. www.accessdata.fda.gov/drugsatfda-docs/nda/2011/202439toc.cfm.
6. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-92.
7. Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369:2093-104.
8. Cohen D. How safe are metal-on-metal hip implants? BMJ 2012;344:e1410. (http://www.bmj.com/content/346/bmj.f837
9. Cohen D. How a fake hip showed up failings in European device regulation. BMJ 2012;345:e7090.
10. Cohen D, Swift G. Laboratories and regulator misled over antibiotic susceptibility test discs. BMJ 2013;346:f837.
11. FDA. Warning letter. HemoSense Corporation, 4 Oct 2005. .www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075594.htm
12. Meier B. Study faults approval process for medical devices. N Y Times 2011Jul 29. www.nytimes.com/2011/07/30/business/study-calls-approval-process-for-medical-devices-flawed.html?-r=0.
13. Mundy A. Firms warn of delays from FDA scrutiny. Wall Street J 2009 Sep 30. www.wsj.com/articles/SB125426793950751021.
14. Cohen D. Dabigatran: how the drug company withheld important analyses. BMJ 2014;349:g4670.