Manufacturer failed to disclose faulty device in rivaroxaban trial

BMJ (Online)

Volumn 354, Issue , 2016, Pages

  Cohen, Deborah ^a  

^a BMJ ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

RIVAROXABAN; WARFARIN;

ACCURACY; ARTICLE; BLEEDING; BLOOD EXAMINATION; BRAIN ISCHEMIA; CLINICAL TRIAL (TOPIC); DEVICE APPROVAL; DEVICE FAILURE; DEVICE SAFETY; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERNATIONAL NORMALIZED RATIO; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; PATIENT SAFETY; POINT OF CARE TESTING; PRIORITY JOURNAL; RELIABILITY; THROMBOEMBOLISM;

EID: 84990873281     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.i5131     Document Type: Article

References (11)

1. Patel MR, Mahaffey KW, Garg J, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-91. doi:10.1056/NEJMoa1009638 pmid:21830957
2. FDA. Alere INRatio and INRatio2 PT/INR monitor system (professional and prescription home use)-falsely low INR test results. 5 Dec 2014. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm429496.htm
3. Thomas K. FDA asks if faulty blood monitor tainted Xarelto approval. New York Times 2016 Feb 23. http://www.nytimes.com/2016/02/23/business/fda-Asks-if-faulty-bloodmonitor-Tainted-xarelto-Approval.html
4. Patel MR, Hellkamp AS, Fox KA. ROCKET AF Executive Committee and Investigators. Patel. Point-of-care warfarin monitoring in the ROCKET AF Trial. N Engl J Med 2016;374:785-8. doi:10.1056/NEJMc1515842 pmid:26839968
5. Patel MR, Hellkamp AS, Fox KA. ROCKET AF Executive Committee, Steering Committee, and Investigators. Point-of-care warfarin monitoring in the ROCKET AF trial. N Engl J Med 2016;375:390-1. doi:10.1056/NEJMc1604020 pmid:27433844
6. United States Securities And Exchange Commission. Alere. https://www.sec.gov/Archives/edgar/data/1145460/000119312516674184/d78820d10k.htm
7. European Medicines Agency. Assessment report: Xarelto. 2016. http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Assessment-Report-Variation/human/000944/WC500201726.pdf
8. Powell JR. Point-of-care warfarin monitoring in the ROCKET AF trial. N Engl J Med 2016;375:390. doi:10.1056/NEJMc1604020 pmid:27433845
9. Cohen D. Rivaroxaban: can we trust the evidence?BMJ 2016;352:i575. doi:10.1136/bmj. i575 pmid:26843102
10. Taborski U, Braun SL, Völler H. Analytical performance of the new coagulation monitoring system INRatio for the determination of INR compared with the coagulation monitor Coaguchek S and an established laboratory method. J Thromb Thrombolysis 2004;18:103-7. doi:10.1007/s11239-004-0206-8 pmid:15789176
11. Bluestein D, Brantley C, Barnes-Eley M, Gravenstein S, Basta S. Measuring international normalized ratios in long-Term care: a comparison of commercial laboratory and point-of-care device results. J Am Med Dir Assoc 2007;8:404-8. doi:10.1016/j.jamda.2007.02.006 pmid:17619039