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U.S. Department of Health and Human Services

About FDA

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Drug Safety Oversight Board Meeting, January 15, 2009

Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs), Early Communications about Ongoing Safety Reviews (ECs) and Information for Healthcare Professionals (HCP) sheets posted since the December 18, 2008 meeting (all available at: Index to Drug-Specific Information) and those risk communications in development.
  • The Drug Safety Oversight Board discussed the comparative safety profile of injectable iron dextran products, which are rarely associated with serious hypersensitivity reactions. These products are used in patients with anemia due to iron deficiency in whom oral administration of iron medications is unsatisfactory or impossible.

 

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