Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine

FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion.

Although FDA has approved two rhBMP products for very specific medical conditions, the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and FDA has not approved it for this use.

Over the past four years, FDA has received about 40 reports of complications associated with using rhBMP in the cervical spine. They involved swelling of neck and throat tissue, which resulted in compression of the airway or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking.

Most of the complications occurred between 2 and 14 days following surgery. When airway complications occurred, emergency medical intervention was frequently necessary.

FDA recommends that practitioners either use approved alternative treatments for cervical spine fusion, or consider enrolling as investigators in approved clinical studies. Patients treated with rhBMP in the cervical spine should seek medical attention immediately if they have symptoms of an airway complication, such as difficulty breathing or swallowing, or swelling of the neck, tongue, mouth, throat, shoulders or upper chest. Patients should be especially watchful 2 to 14 days following the procedure, when airway complications are more likely to occur.

Additional Information:

FDA MedWatch Safety Alert. Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion. July 2, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein