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U.S. Department of Health and Human Services

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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.