Scientific Publications by FDA Staff
Clin Orthop Relat Res 2012 Nov 7 [Epub ahead of print]
Adverse Events After Recombinant Human BMP2 in Nonspinal Orthopaedic Procedures.
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. QUESTIONS/PURPOSES: 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.
|Category: Journal Article|
|PubMed ID: #23132207|
|Includes FDA Authors from Scientific Area(s): Biologics|
|Entry Created: 2012-11-09|