FDA Warning of Suicidal Risk Associated with Antidepressants in Juveniles and Young Adults Reviewed at Recent ISCTM Meeting

    WASHINGTON, March 6 /CNW/ - The International Society for CNS Clinical
Trials and Methodology (ISCTM) held its 2008 annual meeting in Washington, DC,
February 25-27. This organization involves collaborative efforts among
academic and research clinicians, representatives of the pharmaceutical
industry, and governmental drug-regulatory bodies to improve methods for
testing efficacy and safety of drugs used to treat psychiatric and
neurological disorders. A half-day symposium explored FDA-required "black-box"
drug safety warnings of evidence of increased risk of suicidal thoughts and
actions during treatment with antidepressants in juvenile and young-adult
patients as a case study.  The symposium was chaired by FDA-advisor Andrew
Leon, Ph.D. (Cornell Medical Center), and Ross J. Baldessarini, M.D. (Harvard
Medical School). Other speakers were Neil Chayet, J.D. (Harvard Medical
School), Thomas Laughren, M.D. (US FDA), James McNulty (Past-President,
National Alliance on Mental Illness [NAMI]), and Sharon-Lise Normand, Ph.D.
(Harvard School of Public Health).

    Dr. Baldessarini noted: "Studies aimed at reducing risk of suicide remain
far less well developed than many other treatments for psychiatric patients,
despite the importance of the problem. Evidence of whether antidepressants
increase or reduce risk of suicidal behaviors remains surprisingly
inconsistent and inconclusive."

    Symposium speakers reviewed evidence supporting the expanded safety
warning for all drug products that are FDA-approved for the treatment of major
depression, that involve 180-million prescriptions a year in the US. The FDA
also is conducting a systematic review of suicidal risks associated with
anti-epilepsy drugs and considering use of more systematic assessments of
suicidal thinking and behaviors to replace current incidental patient and
clinician reporting of adverse events during trials.

    Suggestions for further action discussed at the symposium include the
need for longer studies of both potential beneficial and adverse effects of
various medicines that act on the brain, as well as greater collaborative
relationships and more open information-sharing among psychiatric patients,
clinicians, researchers, the pharmaceutical industry, and FDA.  Redoubled
efforts are needed to identify more tolerable, safer and more effective
treatments for depression, and to limit suicidal risks, as well as adequate
information to guide sound treatment planning so as to balance risks and
benefits of antidepressant treatment. ISCTM plans to continue its
consideration of methods for suicide assessment with drugs that act on the
brain, and approaches to treatments aimed at reducing suicidal risks.

    For information on ISCTM: http://www.isctm.org.

For further information:

For further information: Carlotta McKee of ISCTM, +1-615-383-7688,
cmckee@isctm.org, Web Site: http://www.isctm.org

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