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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: July 12, 2007 Public Summary

  • The Executive Director updated the Board on Information Sheets and Public Health Advisories (PHAs) posted since the last meeting regarding the drugs:
    • Gadolinium-containing contrast agents (MultiHance, Omniscan, Magnevist, Prohance, OptiMARK)
    • Propofol (Diprivan and generic products)
    • Colistimethate (Coly-Mycin M and generic products)
    • Omalizumab (Xolair)
  • The new and updated information for healthcare professionals sheets, PHAs and other safety information were announced through MedWatch, CDER’s audio Podcasts and under News from CDER at: CDER's home page  
  • The Board received updates about ongoing topics including providing information to healthcare professionals on use of over-the counter cough and cold medicines in children.
  • The Board discussed the following:
    • The actions FDA could take to better inform physicians about the appropriate prescribing practices for fentanyl transdermal patches.
    • The use of disclaimers on FDA’s Healthcare Provider (HCP) sheets
    • An early draft of a document outlining CDER’s principles for risk-based decision making.
  • The Board heard a presentation from the Safety Policy and Communications Staff about the ongoing risk communication strategic planning effort.
  • The Board heard a presentation of a recent emerging, potential safety issue, which served as the basis for the continuing safety communication policy discussion.