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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: October 26, 2006

Pulbic Summaries

  • The Executive Director updated the Board on Information Sheets and Public Health Advisories (PHAs) posted since the last meeting regarding the drugs lamotrigine (Lamictal) and aprotinin (Trasylol). The new sheets, PHAs, and other safety information were announced through MedWatch as well as under CDER's home page
     
  • The Board received updates about ongoing topics including the risk of adverse events following use of fluoroquinolone antibiotics, and use of agents to treat macular degeneration. Adverse events associated with fluoroquinolones have been the subject of two citizen petitions.
     
  • The Board heard presentations on the history of Agency communication with patients/consumers and healthcare providers, and on the communication tools currently employed by CDER to provide information to those groups. It discussed the range of risk communication documents now in use and how to focus a risk communication strategy for the Center.