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FDA Warning Of Suicidal Risk Associated With Antidepressants In Juveniles And Young Adults Reviewed At Recent ISCTM Meeting
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.
International Society for CNS Clinical Trials and Methodology
http://www.isctm.org
FDA de avertizare a suicidarã riscurile asociate cu antidepresive în rândul minorilor ºi a tinerilor adulþi sunt analizate la reuniunea recentã ISCTM - FDA Warning Of Suicidal Risk Associated With Antidepressants In Juveniles And Young Adults Reviewed At Recent ISCTM Meeting - articole medicale engleza - startsanatate