Postmarketing safety of biologics and biological devices

Spine Journal

Volumn 14, Issue 3, 2014, Pages 560-565

  Woo, Emily Jane ^a  

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

Author keywords

Adverse events; Biological products; FAERS; FDA; MAUDE; Medical devices; Postmarketing safety; Surveillance

Indexed keywords

BIOLOGICAL PRODUCT; BOVINE SERUM ALBUMIN; CALCIUM PHOSPHATE; FIBRIN GLUE; ORAL POLIOMYELITIS VACCINE; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; SEALANT;

ADVERSE OUTCOME; AEROSOL; AIR EMBOLISM; AIRWAY OBSTRUCTION; ALLOGRAFT; ALLOTRANSPLANTATION; BIOLOGICAL THERAPY; BONE GRAFT; BONE MATRIX; CARTILAGE CELL; CELL CULTURE; CERVICAL SPINE; CLINICAL TRIAL (TOPIC); CONSUMER; DATA ANALYSIS; DATA BASE; DATA MINING; DEVICE APPROVAL; DISEASE ASSOCIATION; DISEASE SEVERITY; DOSE RESPONSE; DRUG SAFETY; DURA MATER; FOOD AND DRUG ADMINISTRATION; GRAFT FAILURE; HEALTH CARE PERSONNEL; HUMAN; HUMAN CELL; HUMAN TISSUE; ILIAC CREST; INFECTION; INTERVERTEBRAL DISKECTOMY; MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE; MEDICAL DEVICE; MEDICAL DEVICE COMPLICATION; MEDICAL LITERATURE; MEDICAL RESEARCH; MONITORING; NURSE; OFF LABEL DRUG USE; ORTHOPEDIC EQUIPMENT; ORTHOPEDIC SURGERY; PATIENT SAFETY; PEDICLE SCREW; PHARMACIST; PHYSICIAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PSEUDARTHROSIS; REGISTER; REVIEW; RISK; RISK BENEFIT ANALYSIS; RISK REDUCTION; SPINE DISEASE; SPINE FUSION; SPINE SURGERY; STATISTICAL SIGNIFICANCE; SURGEON; TRABECULAR BONE; TREATMENT FAILURE; UNSPECIFIED SIDE EFFECT; ADVERSE EFFECTS; DEVICES; METHODOLOGY; PROCEDURES; RISK FACTOR;

BIOLOGICAL PRODUCTS; EQUIPMENT AND SUPPLIES; HUMANS; ORTHOPEDIC PROCEDURES; PRODUCT SURVEILLANCE, POSTMARKETING; RESEARCH DESIGN; RISK FACTORS; SPINAL FUSION;

EID: 84894495814     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2013.09.056     Document Type: Article

References (35)

1. J.S. Kirkpatrick, and T. Stevens The FDA process for the evaluation and approval of orthopaedic devices J Am Acad Orthop Surg 16 2008 260 267
2. U.S. Food and Drug Administration. Manufacturer and User Facility Device Experience Database - (MAUDE). Available at: http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ ucm127891.htm. Accessed August 23, 2013.
3. U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Available at: http://www.fda.gov/Safety/ MedWatch/default.htm. Accessed August 23, 2013.
4. U.S. Food and Drug Administration. Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Available at: http://www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm074000.htm. Accessed August 23, 2013.
5. U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) (formerly AERS). Available at: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default. htm. Accessed August 23, 2013.
6. Code of Federal Regulations. 21 CFR 600.80.
7. U.S. Food and Drug Administration. Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting. Available at: http://www.fda.gov/ BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/ucm152576.htm. Accessed August 23, 2013.
8. Code of Federal Regulations. 21 CFR 1271.350 (a).
9. U.S. Food and Drug Administration. FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) Product List. Available at: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/ RegulationofTissues/ucm150485.htm. Accessed August 23, 2013.
10. A.B. Hill The environment and disease: association or causation? Proc R Soc Med 58 1965 295 300
11. S. Rosenthal, and R. Chen The reporting sensitivities of two passive surveillance systems for vaccine adverse events Am J Public Health 85 1995 1706 1709
12. U.S. Food and Drug Administration 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 August 23, 2013.
13. INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device. INFUSE® Bone Graft/INTER FIX™ Threaded Fusion Device. INFUSE® Bone Graft/INTER FIX™ RP Threaded Fusion Device - Reduced Profile. Available at: https://www.infusebonegraft.com/spine-package-insert.pdf. Accessed August 23, 2013.
14. E.J. Woo Recombinant human bone morphogenetic protein 2: adverse events reported to the manufacturer and user facility device experience database Spine J 12 2012 894 899
15. E.J. Woo Adverse events after recombinant human BMP2 in nonspinal orthopaedic procedures Clin Orthop Relat Res 471 2013 1707 1711
16. E.J. Woo Dural repair with spinal sealants Spine J 12 2012 279
17. U.S. Food and Drug Administration. FDA Safety Notification: Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants - Evicel. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/ LicensedProductsBLAs/FractionatedPlasmaProducts/ucm219997.htm. Accessed August 23, 2013.
18. U.S. Food and Drug Administration. Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants (Baxter Healthcare Corporation). Available at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm209778.htm. Accessed August 23, 2013.
19. U.S. Food and Drug Administration. FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm218523.htm. Accessed August 23, 2013.
20. U.S. Food and Drug Administration. April 2010 Drug Safety Labeling Changes. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ ucm209165.htm. Accessed August 23, 2013.
21. U.S. Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between January - March 2011. Available at: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm258366.htm. Accessed August 23, 2013.
22. T.K. Mallick, A. Mosquera, and C.E. Zinderman et al. Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010 Cell Tissue Bank 13 2012 259 267
23. S. Wang, C. Zinderman, R. Wise, and M. Braun Infections and human tissue transplants: review of FDA MedWatch reports 2001-2004 Cell Tissue Bank 8 2007 211 219
24. U.S. Food and Drug Administration. Postmarket Drug and Biologic Safety Evaluations. Available at: http://www.fda.gov/drugs/ guidancecomplianceregulatoryinformation/surveillance/ucm204091.htm. Accessed August 23, 2013.
25. U.S. Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS). Available at: http://www.fda.gov/drugs/ guidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm082196.htm. Accessed August 23, 2013.
26. U.S. Food and Drug Administration. Questions and Answers on the Federal Register Notice on Drugs and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies. Available at: http://www.fda.gov/ RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ ucm095439.htm. Accessed August 23, 2013.
27. U.S. Food and Drug Administration. Postmarketing Requirements and Commitments: Legislative Background. Available at: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ ucm064633.htm. Accessed August 23, 2013.
28. U.S. Food and Drug Administration. Post approval studies. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma-pas.cfm. Accessed August 23, 2013.
29. U.S. Food and Drug Administration. FDAAA Implementation - Highlights Two Years After Enactment. Available at: http://www.fda.gov/RegulatoryInformation/ Legislation/FederalFoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ ucm184271.htm. Accessed August 23, 2013.
30. U.S. Food and Drug Administration. FDA's Sentinel Initiative - Ongoing Projects. Available at: http://www.fda.gov/Safety/FDAsSentinelInitiative/ ucm203500.htm. Accessed August 23, 2013.
31. M.R. Southworth, M.E. Reichman, and E.F. Unger Dabigatran and postmarketing reports of bleeding N Engl J Med 368 2013 1272 1274
32. S. Toh, M.A. Baker, J.S. Brown Mini-Sentinel Investigators Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration's Mini-Sentinel program JAMA Intern Med 173 2013 817 819
33. W.M. Mihalko, A.S. Greenwald, J. Lemons, and J. Kirkpatrick Reporting and notification of adverse events in orthopaedics J Am Acad Orthop Surg 18 2010 193 198
34. 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
35. FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone. Morphogenetic Protein in Cervical Spine Fusion. Available at: http://www.spine.org/Documents/rhBMP-cervical-7-08-rev%20-2-.pdf. Accessed August 23, 2013.