Strengthening Safeguards for Children Treated With Antidepressant Medications

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"Today's appointments signify FDA's end something like the increased risk of suicidal view and the reproachful actions for physician prescribe these antidepressant drugs and for the offspring and adolescents taking them. Our conclusions be platform on the up-to-the-minute and fastest science. They emulate what we hear from our advisory committee ending month, in plant of resourcefully as what copious member of the town not public tell us," said Dr. Lester M. Crawford, Acting FDA Commissioner.

In correspondence issue today, FDA directed the manufacturers of all antidepressant medications to add a "black box" warning that describe the increased risk of suicidality in children and adolescents given antidepressant medications and commotion what pay out the drugs have be conceded or not approved for in these patients. FDA's letters to the manufacturers also deliberate other labeling change designed to consist of optional conditions about pediatric study of these drugs. These labeling changes are applicable to the complete category of antidepressant medications because the now permitted data are not so-so to shun any solo medication from the increased risk of suicidality.

Prozac is currently the merely medication approved to pleasure devaluation in children and adolescents. The analyses of the placebo controlled torment in children and adolescents summarized in the revise labeling are based on studies of five selective serotonin reuptake inhibitors (SSRIs) (Celexa, Prozac, Luvox, Paxil and Zoloft) and four "atypical" antidepressants (Wellbutrin, Remeron, Serzone and Effexor XR). In these studies, in that be no report luggage of a suicide.

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