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Drug Safety and Availability

Drug Safety Oversight Board - Volume 2, Number 3, 2009

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FDA’s Drug Safety Oversight Board (DSB) was formed in 2005 to provide advice to the CDER Center Director on managing and communicating emerging drug safety issues. The DSB also provides a forum for discussion and arbitration of internal debates concerning the management of potential drug safety issues. The DSB does not provide clinical recommendations or advice to healthcare professionals or the public. The Board meets monthly and is composed of representatives throughout FDA and our other federal partners, such as the National Institutes of Health, Department of Veterans Affairs, Centers for Disease Control and Prevention, Department of Defense, and Agency for Healthcare Research and Quality. Although meetings are internal, a summary of each meeting is posted on FDA’s web site.

Drug Safety Oversight Board Meeting Summary

May 21, 2009: The DSB discussed the role of meta-analyses in FDA's reviews of drug safety. The Board specifically addressed meta-analysis performed by academia and other health care organizations where the results identified a new drug safety issue not addressed in the full prescribing information for the drug product. The Board discussed how FDA should best understand and incorporate the abundance of research publications using meta-analyses into its decision-making processes involving drugs. 
DSB Board Meeting Public Summary

June 18, 2009: 
The DSB discussed reports of metabolic acidosis, metabolic acidosis with increased anion gap, and neuropsychiatric adverse events in children using polyethylene glycol (PEG) products. Neuropsychiatric adverse events include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings. The Board discussed whether the adverse event reports could constitute a safety signal for use of PEG products in children and what action, if any, might be appropriate for the prescription and over-the-counter preparations.
DSB Board Meeting Public Summary

July 16, 2009: 
The DSB heard presentations on the following topics:

  1. The Freedom of Information Act and how it applies to the DSB.
  2. The Veterans Health Administration and FDA collaboration on the propoxyphene issues.
  3. Goals and scope of FDA’s Safe Use Initiative: The Board discussed what types of Safe Use projects would be of interest, how Safe Use could define project priorities and boundaries, and what can be used as measures of success.
  4. A Follow-up on 21 Early Communications about an Ongoing Safety Review (ECs) issued from August 2007 to July 2009: Elements of an EC were given along with a brief description of each EC, the projected date for follow-up, actual date of follow-up, and the follow-up actions.

DSB Board Meeting Public Summary


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