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Title: Use of rhBMP in Cervical Spine Fusion Linked to Life-Threatening Adverse Events
URL: http://www.pslgroup.com/dg/224D52.htm
Doctor's Guide
July 2, 2008

ROCKVILLE, Md -- July 2, 2008 -- The US Food and Drug Administration (FDA) today informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine.

There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing, or speaking.

The FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

SOURCE: The US Food and Drug Administration

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