Drug Safety Oversight Board Meeting: February 23, 2006, Public Summary
The Executive Director updated the Board on patient information and healthcare professional sheets (described below as “sheets”) and Public Health Advisories (PHAs) posted since the last meeting, and the Board discussed several of the actions. The drugs for which sheets and/or PHAs were posted included
Neutrospec (technetium (99m Tc) fanolesomab)
Nimotop (nimodipine capsules)
Trasylol (aprotinin injection)
Benzocaine Sprays marketed under different names, including Hurricaine, Topex, and Cetacaine
The Board also discussed other emerging safety issues and strategies being considered to manage and track identified safety issues in CDER.