Kids on Antidepressants Suicide Alert

Oct. 28, 2003 -- The US Food and Drug Administration (FDA) yesterday issued a Public Health Advisory to alert physicians to reports of suicidal thinking and suicide attempts by children and teenagers during clinical trials of antidepressant drugs for major depressive disorder. The FDA statement appears below.

Comment: We believe this is a very important matter. Physicians are not the only ones who need to be aware of the risk of suicide among children and adolescents who are on or coming off antidepressants. We all need to be concerned and alert to this possible danger.

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Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com


FDA Issues Public Health Advisory Entitled: Reports Of Suicidality in Pediatric Patients Being Treated with Antidepressant Medications for Major Depressive Disorder (MDD)

The Food and Drug Administration (FDA) is issuing a Public Health Advisory to alert physicians to reports of suicidal thinking (and suicide attempts) in clinical studies of various antidepressant drugs in pediatric patients with major depressive disorder (MDD).

FDA recognizes that pediatric MDD is a serious condition for which there are few established treatment options. In addition to use of non-medication approaches to treatment, clinicians must often make choices among drug treatments available for adult MDD. Currently, Prozac (fluoxetine) is the only drug labeled for use in Pediatric MDD, and was approved recently under the Pediatric Exclusivity provision.