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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: March 1, 2007 Public Summary

  • The Executive Director updated the Board on Information Sheets and Public Health Advisories (PHAs) posted since the last meeting regarding the following drugs:
    • Drugs to treat attention deficit hyperactivity disorder (ADHD)
    • Omalizumab (Xolair)
    • Erythropoiesis-stimulating agents (Procrit, Epogen, and Aranesp)
    • Telithromycin (Ketek)
    • Skin products containing numbing ingredients used for cosmetic procedures
    • Gadolinium-containing contrast agents for magnetic resonance imaging (Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance)
    • Rituximab (Rituxan)
    • Methadone
The new and updated sheets, PHAs, and other safety information were announced through MedWatch, FDA Patient Safety News, CDER’s new audio Podcast project (first topic was on skin products containing numbing ingredients used for cosmetic procedures), as well as under News from CDER at: CDER's home page
  • The Board received updates from the Fentanyl Working Group. 

     
  • Dr. Galson asked for the Board’s recommendations for addressing the CDER drug safety culture issues described in the Institute of Medicine report.

     
  • The Board received a report from the January 17-18, 2007 DSOB off-site development meeting and continued discussions on next steps and other topics raised at the off-site.