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Free Content Recent U.S., Canadian, and British Regulatory Agency Actions Concerning Antidepressant-induced Harm to Self and Others: A Review and Analysis

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Drug regulatory agencies in the United States, Great Britain, and Canada have recently issued warnings concerning the use of antidepressants. Considerable attention has been placed on regulatory agency conclusions that antidepressants are associated with increased rates of suicidality in children. In the United States (the FDA) and Canada (Health Canada), new warnings have also been issued for children and adults concerning the production of an activation or stimulant syndrome that is known to be associated with violence and suicide. Health Canada requires a warning that selective serotonin inhibitors (SSRIs) and other newer antidepressants produce in children and adults "agitation-type adverse events coupled with self-harm or harm to other," including "akathisia (psychomotor restlessness), agitation, disinhibition, emotional lability, hostility, aggression, depersonalization." The FDA requires a warning that "The following symptoms; anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric." Recent studies confirm that antidepressants are associated with adverse events that can cause aggression, hostility, and violence, as well as suicidality, in both children and adults.
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Keywords: Antidepressants; FDA; SSRIs; labeling; violence

Document Type: Journal Article

Affiliations: MD Ithaca, NY

Publication date: January 1, 2005

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