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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, January 19, 2012

Public Summary

Citalopram Drug Safety Communication (DSC

The Board heard a presentation from Tom Laughren, MD, Director, Division of Psychiatry Products

Dr. Laughren discussed the citalopram DSC issued on August 24, 2011: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide).

The Board discussed the overall safety of citalopram in the context of a possible association with abnormal heart rhythms.

CDER Office of Communications (OCOMM) Focus Group

OCOMM contracted with Deloitte Consulting to conduct a focus group soliciting DSB insights on DSCs. The purpose of the focus group is to help the Center gain a better understanding of the DSB’s perceptions of DSCs. Follow-up on outcomes from this session will be presented at a future DSB meeting.

OCOMM Discussion: Possible New Communication Category on Cessation of Clinical Trials

The Board heard a presentation by Gregory Busse, Ph.D, OCOMM, regarding a possible new communication category on cessation of clinical trials. Dr. Busse solicited feedback on whether a new communication tool is needed for greater visibility and more targeted efforts to distribute to the healthcare community.

The Board discussed the relevance and need of a new communication category (cessation of a clinical trial), factors that would trigger such a communication, and importance to the healthcare provider community.

Public Use of AERS: Research Value and Needed Improvements

The DSB heard a presentation from Thomas Moore, Senior Scientist, Institute for Safe Medication Practices (ISMP) and subsequently discussed current sources of safety data, safety issues, and AERs system performance.

The Role of Adverse Event Reporting in a Postmarket Drug Safety System

The DSB heard a presentation from Gerald Dal Pan, MD, MHS, Acting Director, Office of Surveillance and Epidemiology. Dr. Pal Pan offered a brief overview on the role of the Adverse Event Reporting Systems (AERS) in a post-marketing drug safety system. He reviewed the development of AERS over its history since its beginnings in the 1960s, the goals of drug safety surveillance, and aspects of the CDER post-marketing surveillance programs.

The Board discussed the widespread availability of claims databases; automated techniques to look at those databases, and development of sentinel systems.