The "Columbia" Study
Because of concerns about whether the varied events identified by sponsors under the broad category of "possibly suicide-related" could all reasonably be considered to represent suicidality, FDA asked Columbia University to assemble an international panel of pediatric suicidality experts to undertake a blinded review of the reported behaviors using a rigorous classification system. The Columbia group submitted its completed review to FDA last month.
FDA has developed its analysis of the pediatric suicidality data, based on case classifications provided by Columbia University, and will be posting the analysis on its web site. While there are findings among these data suggestive of an increased risk of suicidality for some of these drugs, there remain inconsistencies in the results, both across trials for individual drugs and across drugs. Thus, an overall interpretation of these findings represents a substantial challenge.
The September FDA Advisory Committee Meeting
FDA's next step, planned for some time, will be to update the Psychopharmacologic Drugs and the Pediatric Advisory Committees about the results of these reviews and to seek assistance from the committees in interpreting the data and in considering what additional regulatory actions may be needed to promote the safe use of these drugs./p]
As a public health agency, FDA must weigh the possibility of an increased risk of suicidality in young patients taking these drugs against the known risk of suicide in patients whose depression goes untreated.
FDA will be bringing the following issues and draft questions to the committees for their input:
- Please comment on our approach to classification of the possible cases of suicidality (suicidal thinking and/or behaviors) and our analyses of the resulting data from the 23 pediatric trials involving 9 antidepressant drugs.
- Do the suicidality data from these trials support the conclusion that any or all of these drugs increase the risk of suicidality in pediatric patients?
- If the answer to the previous question is yes, to which of these 9 drugs does this increased risk of suicidality apply? Please discuss, for example, whether the increased risk applies to all antidepressants, only certain classes of antidepressants, or only certain antidepressants.
- If there is a class suicidality risk, or a suicidality risk that is limited to certain drugs in this class, how should this information be reflected in the labeling of each of the products? What, if any, additional regulatory actions should the Agency take?
- Please discuss what additional research is needed to further delineate the risks and benefits of these drugs in pediatric patients with psychiatric illness.
The meeting will be held in Bethesda, Maryland on September 13 and 14, 2004. So that all interested parties will have ample opportunity to review the information to be discussed next month, FDA will be posting information on its website at http://www.fda.gov/cder/pediatric/Summaryreview.htm and http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm.
