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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: May 31, 2007 Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs) and Healthcare Professional (HCP) information sheets posted since the last meeting, including the May 21, 2007 HCP information sheet on Rosiglitazone (Avandia) for type II diabetes, and the May 23, 2007 press release and updated HCP information sheet on Gadolinium Based Contrast Agents for Magnetic Resonance Imaging (MRI) (marketed as Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance).  The new HCP sheet highlights a request from CDER to all GBCA manufacturers to add new warnings (including a boxed warning) to the full prescribing information for all gadolinium-based contrast agents. The requested new product labeling describes the risk of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) in certain patients with renal failure and provides recommendations for risk screening, management and follow-up (Information on Gadolinium-Containing Contrast Agents).
  • The Board received updates about ongoing topics including the establishment of an agency-level advisory committee on risk communication, the upcoming launch of an online newsletter on drug safety targeted toward healthcare professionals, a survey of current safety policy programs in CDER, and discussed ongoing safety communications policy development.
  • The Board was briefed on efforts to study comparatively the benefits and risks of Avastin and Lucentis for age-related macular degeneration.