Recombinant human bone morphogenetic protein-2: Adverse events reported to the Manufacturer and User Facility Device Experience database

Spine Journal

Volumn 12, Issue 10, 2012, Pages 894-899

  Woo, Emily Jane ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Adverse event; Bone morphogenetic protein; Off label use; Postmarketing safety

Indexed keywords

INFUSE BONE GRAFT; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; UNCLASSIFIED DRUG;

AZOOSPERMIA; CEREBROSPINAL FLUID OTORRHEA; CLINICAL TRIAL (TOPIC); COMORBIDITY; DEEP VEIN THROMBOSIS; DRUG HYPERSENSITIVITY; FEVER; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; HETEROTOPIA; HUMAN; KIDNEY DISEASE; LUNG COMPLICATION; LUNG EMBOLISM; MALE STERILITY; NEUROLOGIC DISEASE; OFF LABEL DRUG USE; OSTEOLYSIS; PEER REVIEW; PLEURA EFFUSION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSEUDARTHROSIS; RADICULOPATHY; RASH; RECURRENT LARYNGEAL NERVE INJURY; REFERENCE DATABASE; REOPERATION; RESPIRATORY DISTRESS; RETROGRADE EJACULATION; REVIEW; SIDE EFFECT; SPINAL CORD TUMOR; SPINE SURGERY; SURGICAL INFECTION; SWELLING; TONGUE SWELLING; WOUND COMPLICATION;

EID: 84870299516     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2012.09.052     Document Type: Article

References (29)

1. Premarket approval. Available at: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pma.cfm. (PMA P000058, original application and supplement S002). Accessed September 21, 2012.
2. INFUSE Bone Graft package insert. Available at: www.infusebonegraft.com/ spine-package-insert.pdf. Accessed September 21, 2012.
3. E.J. Carragee, E.L. Hurwitz, and B.K. Weiner A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned Spine J 11 2011 471 491
4. T.E. Mroz, J.C. Wang, R. Hashimoto, and D.C. Norvell Complications related to osteobiologics use in spine surgery: a systematic review Spine 35 9 Suppl 2010 S86 S104
5. D. Benglis, M.Y. Wang, and A.D. Levi A comprehensive review of the safety profile of bone morphogenetic protein in spine surgery Neurosurgery 62 5 Suppl 2 2008 ONS423 ONS431 discussion ONS431
6. J.K. Burkus, M.F. Gornet, C.A. Dickman, and T.A. Zdeblick Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages J Spinal Disord 15 2002 337 349
7. S.D. Boden, J. Kang, H. Sandhu, and J.G. Heller Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies Spine 27 2002 2662 2673
8. J.D. Smucker, J.M. Rhee, and K. Singh Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine Spine 31 2006 2813 2819
9. J.W. McClellan, D.S. Mulconrey, R.J. Forbes, and N. Fullmer Vertebral bone resorption after transforaminal lumbar interbody fusion with bone morphogenetic protein (rhBMP-2) J Spinal Disord Tech 19 2006 483 486
10. Manufacturer and User Facility Device Experience Database. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/ postmarketrequirements/reportingadverseevents/ucm127891.htm. Accessed September 21, 2012.
11. FDA Public Health Notification: life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion. Available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ publichealthnotifications/ucm062000.htm. Accessed September 21, 2012.
12. L.B. Shields, G.H. Raque, and S.D. Glassman Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion Spine 31 2006 542 547
13. B.B. Pradhan, H.W. Bae, and E.G. Dawson Graft resorption with the use of bone morphogenetic protein: lessons from anterior lumbar interbody fusion using femoral ring allografts and recombinant human bone morphogenetic protein-2 Spine 31 2006 E277 E284
14. J.A. Rihn, R. Patel, and J. Makda Complications associated with single-level transforaminal lumbar interbody fusion Spine J 9 2009 623 629
15. A. Sethi, J. Craig, and S. Bartol Radiographic and CT evaluation of recombinant human bone morphogenetic protein-2-assisted spinal interbody fusion AJR Am J Roentgenol 197 2011 W128 W133
16. N.F. Chen, Z.A. Smith, and E. Stiner Symptomatic ectopic bone formation after off-label use of recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion J Neurosurg Spine 12 2010 40 46
17. D.A. Wong, A. Kumar, and S. Jatana Neurologic impairment from ectopic bone in the lumbar canal: a potential complication of off-label PLIF/TLIF use of bone morphogenetic protein-2 (BMP-2) Spine J 8 2008 1011 1018
18. V. Joseph, and Y.R. Rampersaud Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis Spine 32 2007 2885 2890
19. J.R. Dimar 2nd, S.D. Glassman, and J.K. Burkus Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis J Bone Joint Surg Am 91 2009 1377 1386
20. D.S. Baskin, P. Ryan, and V. Sonntag A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate Spine 28 2003 1219 1224
21. M. Salas, A. Hofman, and B.H. Stricker Confounding by indication: an example of variation in the use of epidemiologic terminology Am J Epidemiol 149 1999 981 983
22. E.J. Carragee, K.A. Mitsunaga, E.L. Hurwitz, and G.J. Scuderi Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study Spine J 11 2011 511 516
23. G.C. Comer, M.W. Smith, and E. Hurwitz Retrograde ejaculation after anterior lumbar interbody fusion with and without bone morphogenetic protein-2 augmentation: a ten-year cohort controlled study Spine J 2012 in press
24. Center for Devices and Radiological Health Medical Devices Advisory Committee, Orthopedic and Rehabilitation Devices Panel. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/ OrthopaedicandRehabilitationDevicesPanel/UCM225538.pdf. Accessed September 22, 2012.
25. K.L. Ong, M.L. Villarraga, and E. Lau Off-label use of bone morphogenetic proteins in the United States using administrative data Spine 35 2010 1794 1800
26. K.S. Cahill, J.H. Chi, A. Day, and E.B. Claus Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures JAMA 302 2009 58 66
27. Premarket approval. Available at: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pma.cfm. (PMA P000058, supplements S007, S020, S027, and S032). Accessed September 21, 2012.
28. Spine safety alert supplement. Available at: http://www.spine.org/ Documents/rhBMP-cervical-7-08-rev -2-.pdf. Accessed September 21, 2012.
29. BMP for cervical fusion? Available at: http://www.spine.org/Pages/ Publications/SpineLine/CurveSurvey/Archives/cc-sle08julaug.aspx. Accessed September 21, 2012.