Briefing Summary: US FDA Posts Advisory Committee Materials for a Review of the Overall Risk-Benefit of Epidural Steroid Injections – NOV 24-25, 2014 (AADPAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Monday and Tuesday, November 24-25, 2014 Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) Meeting. The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESIs) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESIs and the overall risk-benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in discussions of possible regulatory options, including, but not limited to, changes to the product labeling.