On July 2, 2008, the AAOS issued a patient safety member alert in response to a public health notification released by the U.S. Food and Drug Administration on July 1, 2008, about reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The FDA noted that the safety and effectiveness of the use of rhBMP in the cervical spine have not been demonstrated and the FDA has not approved these products for this use.
The FDA has received at least 38 reports of complications involving the use of rhBMP in cervical spine fusion. Complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurologic structures in the neck. Some reports describe difficulty swallowing, breathing, or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.
Anatomic proximity of the cervical spine to airway structures in the body has contributed to the seriousness of the events reported and the need for emergency medical intervention. The mechanism of action is unknown, and characteristics of patients at increased risk have not been identified.
Most complications occurred between 2 and 14 days postoperatively and frequently required second surgeries to drain the surgical site. Other medical interventions included respiratory support with intubation, anti-inflammatory medication, and tracheotomy.
Because of the serious adverse events, the FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies. Practitioners who treat patients with rhBMP in the cervical spine should do as follows:
- Educate patients about the signs and symptoms of airway complications
- Direct patients to seek medical attention immediately at the first sign of an airway complication
- Instruct patients to be especially watchful 2 to 14 days after the procedure when airway complications are most likely to occur
- Any adverse reactions or problems experienced with the use of this product can be reported through the FDA’s MedWatch Program or by phone at 1-800-FDA-1088.
Questions should be directed to Katherine Sale, AAOS manager of biomedical research and regulation, at email@example.com or (847) 384-4327.