Expanded indication for recombinant human bone morphogenetic protein 2

Spine

Volumn 36, Issue 21, 2011, Pages 1817-

  Woo, Emily Jane ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

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

ACCURACY; ANTERIOR LUMBAR INTERBODY FUSION; ANTERIOR SPINE FUSION; DEGENERATIVE DISC DISEASE; DEVICE; DRUG APPROVAL; EDUCATION; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERVERTEBRAL DISK DEGENERATION; LETTER; OFF LABEL DRUG USE; PRIORITY JOURNAL; TREATMENT INDICATION; CLINICAL PRACTICE; DRUG LABELING; FEMALE; HEALTH CARE DISPARITY; MALE; NOTE; SPINE FUSION; STATISTICS;

BONE MORPHOGENETIC PROTEINS; DRUG LABELING; FEMALE; HEALTHCARE DISPARITIES; HUMANS; MALE; OFF-LABEL USE; PHYSICIAN'S PRACTICE PATTERNS; SPINAL FUSION;

EID: 80053358773     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0b013e31822e603c     Document Type: Letter

References (3)

1. Ong KL, Villarraga ML, Lau E, et al. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine 2010;35:1794-1800.
2. US Food and Drug Administration. July 2004 PMA Approvals. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/PMAApprovals/ucm110915.htm. Accessed August 29, 2011.
3. US Food and Drug Administration. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion. http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000 htm. Accessed August 29, 2011.