FDA issues new policies on treatment of children with antidepressants

The Food and Drug Administration issued a Public Health Advisory Friday with new labeling requirements aimed at warning the public about increased risks of suicidal thoughts and behavior in children treated with antidepressants. Under the new rules, drugmakers will be required to include a "black box" warning on antidepressants to alert healthcare providers and users of the risks to children and approved uses. Prozac is the only antidepressant approved for use by children, but many physicians have prescribed others. The rules also require doctors to provide patients a medication guide with more information on risks and uses of the drugs. Read the FDA press release. The agency has more information on antidepressants.

UPDATE: An AP story is now available.

 

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