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
-
Campath (alemtuzumab)
-
Paxil (paroxetine)
-
Biaxin (clarithromycin)
-
Neutrospec (technetium (99m Tc) fanolesomab)
-
Ketek (telithromycin)
-
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.
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DSOB Meeting Summaries
Date created: March 3,
2006 |