FDA Issues Warning Regarding Off-Label Use of rhBMP
BY LAUREN UZDIENSKI, JULY 7, 2008
Last week the FDA released a public health notification regarding the off-label use of of rhBMP (InFuse, OP-1) in the cervical spine. The agency says that over the past four years there have been at least 38 reports of complications associated with using BMP in unapproved cervical fusion cases, ranging from difficulty swallowing, breathing or speaking to severe dysphagia.
Most reported complications occurred between two and 14 days following surgery. Treatments included respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly second surgeries to drain the surgical site. The seriousness of the complications was correlated with the anatomical proximity of the cervical spine to airway structures. The FDA adds, "The mechanism of action is unknown, and characteristics of patients at increased risk have not been identified."
InFuse (BMP-2) is currently approved for use in lumbar fusion in L2-S1, open tibial shaft fractures stabilized with an IM nail and certain oral and maxillofacial applications. OP-1 (BMP-7) received an HDE for use in, under certain conditions, long bone nonunions and for revision posterolateral lumbar fusion. The FDA is currently reviewing Stryker's PMA application, with approval expected late this year; it will be interesting to see if BMP worries cast a cloud over this much-anticipated product.
