FDA Calls for Antidepressant Labels to Warn of Suicidality Risk in Young Adults

May 07, 2007

May 7, 2007 — The US Food and Drug Administration (FDA) gave antidepressant manufacturers 30 days from May 2 to update black-box warnings of suicidality (suicidal thinking and behavior) on their product labels and warnings in their medication guides for patients.

The FDA proposes that first, the new warnings should mention risk for suicidality upon initial treatment (generally within 1 to 2 months) of young adults aged 18 to 24 years. Second, the updates should note that scientific data did not show an increased risk for suicidality in adults over the age of 24 years and showed a decreased risk for suicidality in adults over the age of 64 years. Finally, the proposed warning statements should emphasize that depression and certain other psychiatric disorders are themselves associated with the risk for suicide.

The proposed labeling revisions follow FDA-mandated changes to product labels in 2005 that warned of increased risk for suicidality in children and adolescents taking antidepressants and emphasized the need for appropriate monitoring and close observation. The FDA has reviewed pooled analyses from 24 short-term trials of 9 antidepressant drugs in over 4400 children and adolescents with depression or other psychiatric disorders, which showed a "reasonably consistent...slight increase" in suicidality in early treatment of most antidepressants.

In 2005, the FDA began a review of scientific data from adult use of antidepressants. They looked at pooled analyses from 295 short-term trials (median duration 2 months) of 11 antidepressant drugs in more than 77,000 adults with depression or other psychiatric disorders. In December 2006, the FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform healthcare professionals about the increased risk for suicidality in younger adults taking antidepressants and of the apparent beneficial effect in older adults and to inform them that the disorders themselves are the most important cause of suicidality.

The FDA's review of the scientific literature found that among young adults aged 18 to 24 years, for every 1000 patients treated with antidepressants vs placebo, there were 5 additional cases of suicidal thoughts and behavior; among adults aged 65 years and older there were 6 fewer cases of suicidality.

Differences in Suicidality (Antidepressants vs Placebo) in Placebo-Controlled Trials*

Age Range (y)
Drug-Related Differences in Suicidality,
per 1000 Patients Treated
< 18
14 additional cases
18 – 24
5 additional cases
25 – 64
1 fewer case
> 65
6 fewer cases
*Pooled analyses from 20 trials of more than 4400 children and adolescents and more than 77,000 adults; suicidality = suicidal thoughts and behavior.

No suicides occurred in the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about the drug effect on suicide. It is unknown whether the suicidality extends to longer-term use beyond several months.

The FDA press release advises that people of any age who are currently taking prescribed antidepressants who have concerns about their medications should not stop taking them but should consult with their physicians.

More information, including a list of all 36 antidepressants, is available online, as is the draft text for antidepressant product labels and for medication guides (intended to be handed out to patients when they get their prescriptions filled at pharmacies).

Manufacturers are asked to submit their revised product labels and medication guides to the FDA for review, by within 30 days of May 2.

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