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

Thursday, March 6, 2008 General News J E 4
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WASHINGTON, March 6 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.



SOURCE International Society for CNS Clinical Trials and Methodology
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