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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting: September 18, 2008, Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs) and Information for Healthcare Professionals (HCP) sheets posted since the July 17, 2008 meeting (all available at: Index to Drug-Specific Information) and those currently in development.

     
  • The Board discussed recent data about the potential for cardiovascular risks with the use of stimulant drugs in children with attention deficit/hyperactivity disorders (ADHD), and the recent statements by the American Heart Association, the American Academy of Pediatrics and other medical organizations regarding the advisability of heart monitoring for children receiving stimulant drugs.

     
  • The Board was updated on a topical tretinoin skin cancer prevention trial that was first discussed at the March 20, 2008, Drug Safety Board Meeting and the plans for the Department of Veterans Affairs to publish the results of this trial.

     
  • The Board had a general discussion with the CDER Center Director about its ongoing role in risk communication and safety policy.