M E M O R A N D U M DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
FROM: Susan Cummins, M.D., M.P.H.
Medical Team Leader
Division of Pediatric Drug Development
Thomas P. Laughren, M.D.
Team Leader, Psychiatric Drug Products
Division of Neuropharmacological Drug Products
SUBJECT: Overview for
TO: Members of PDAC and Peds AC
On February 2nd, the PDAC and Peds AC will meet to consider the emergence of suicidality in the course of treatment of pediatric patients with various antidepressants, in particular, those patients being treated for major depressive disorder (MDD). At the meeting, we will present background information on this issue, data from the Adverse Event Reporting System (AERS) database, and preliminary data from placebo-controlled clinical trials in pediatric MDD. We have two goals for this meeting: to provide both committees with background information on these issues and to obtain advice from you about how to best address the methodological issues involved in the further evaluation and interpretation of these data so that you can help us to move forward in addressing this concern. We anticipate that we will hold a second meeting in the summer of 2004 to seek further advice on these issues.
To prepare you for these deliberations, you will first hear
presentations by experts in adolescent suicidality. Dr. Cynthia Pfeffer, from the Weill Medical
College of Cornell University, will address adolescent depression and
suicidality, and its treatment generally.
Dr. David Shaffer, from the
Dr. Solomon Iyasu, Medical Team Leader with the Division of Pediatric Drug Development will report on adverse events, including treatment emergent suicidality, for the first year of marketing following the granting of exclusivity for the following two drugs that were granted market exclusivity under 505A of the Federal Food, Drug, and Cosmetic Act: Paxil (paroxetine) and Celexa (citalopram). These reports are required under section 17 of the Best Pharmaceuticals for Children Act. Importantly, his talk will be followed by presentations from staff of the Office of Drug Safety on spontaneous reports of treatment emergent suicidality for the first three years of marketing for all antidepressant drugs in order to place the findings Dr. Iyasu will be presenting into perspective.
Dr. Laughren will provide an overall clinical and regulatory
perspective on the evolution of concerns about suicidality associated with
antidepressant drug treatment, with a particular focus on the recently emerging
suicidality data from various drug development programs involving the use of
antidepressant drug products in pediatric patients with MDD. Dr. Kelly Posner, from
There will be two open public sessions during the Feb 2nd meeting, one in morning, and one in the afternoon, to provide an opportunity for others in the community to make statements pertinent to this concern about a possible causal association between antidepressant drug treatment and emergent suicidality in pediatric patients.
While we will not be seeking specific votes from the committees on any definitive regulatory actions regarding this concern, we will seek your guidance on various methodological issues pertinent to our continuing review of the clinical trials data. These methodological questions are presented in Dr. Laughren’s separate background memo for the committees.
The background package for this meeting will include the following documents in addition to this cover memo:
The FDA relies on the knowledge, judgement, experience and wisdom of scientists and practitioners like you to help determine how to move forward and address newly emerging issues related to drug development. We thank you for your time and effort, and we look forward to seeing and hearing from you on Feb 2nd.