title: Adverse events after recombinant human BMP2 in nonspinal orthopaedic procedures.
abstract: BACKGROUND
  The FDA has approved recombinant human bone morphogenetic protein 2 (rhBMP-2) for treating acute, open tibial shaft fractures. However, the nature and frequency of complications after the use of rhBMP-2 in nonspinal orthopaedic surgery have not been well characterized.
  
  
  OBJECTIVE
  To determine what types of adverse events have been reported after the use of rhBMP-2, whether they were severe enough to require additional surgery, and after what types of operations these adverse events occurred.
  
  
  METHODS
  Adverse events reported to the FDA's Manufacturer and User Facility Device Experience database were reviewed and summarized.
  
  
  RESULTS
  Through December 31, 2011, the FDA has received 62 reports of adverse events involving rhBMP-2 in nonspinal orthopaedic procedures. Surgical site infections and other wound complications, heterotopic bone, pseudarthrosis, and local inflammation were among the most commonly reported adverse events. Almost half of the reports (30 reports; 48%) stated that the patients required secondary interventions to address the reported adverse events. The majority (49 reports; 79%) described adverse events occurring after unapproved uses, such as management of tibial plateau fractures, treatment of congenital pseudarthrosis of the tibia, and humeral reconstruction.
  
  
  CONCLUSIONS
  Serious adverse events can occur after the use of rhBMP-2 in nonspinal orthopaedic procedures and may necessitate additional surgery. Most events in this analysis occurred after off-label uses. Postmarketing review of adverse event reports remains an important approach for identifying potential safety concerns.
authors.affiliation: US Food and Drug Administration, HFM-222, 1401 Rockville Pike, Rockville, MD 20852, USA. jane.woo@fda.hhs.gov
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D055396:Bone Morphogenetic Protein 2 / Q000009:adverse effects*; D005592:Fracture Fixation / Q000009:adverse effects*; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology / Q000601:surgery; D011994:Recombinant Proteins / Q000009:adverse effects; D012086:Reoperation; D012307:Risk Factors; D013978:Tibial Fractures / Q000188:drug therapy* / Q000601:surgery*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins