Health Canada and U.S. FDA Advisories for Antidepressants

Health Canada and U.S. FDA Advisories for Antidepressants


Health Canada and the U.S. Food and Drug Administration (FDA) have issued advisories to patients, families, and health professionals to closely watch for warning signs of suicidal behaviour in children and adults younger than 25 who take antidepressants.

Health Canada and the FDA also advise patients to watch for an increase in anxiety, panic attacks, agitation, irritability, insomnia, impulsivity, hostility, and mania. It is most important to watch for these behaviours in children. That's because children are less able to control their impulses. They may be at greater risk for suicidal behaviours.

Health Canada and the FDA have not recommended that children and young adults stop using antidepressants. If you have concerns about a child or young adult who is taking an antidepressant, talk to a doctor.

If your child is taking an antidepressant, watch carefully for warning signs. Pay extra attention during the first few weeks of treatment and when doses are changed. If you are concerned about the advisories or about warning signs of suicide, talk to your child's doctor.

No one should ever stop taking antidepressants suddenly. These medicines should be tapered off slowly and only under the supervision of a health professional. Abruptly stopping antidepressants can cause side effects or a relapse into another depressive episode.

Suicidal thoughts

Suicidal thoughts and behaviour are a risk for an antidepressant. But experts recognize that for many young people, the benefits of taking an antidepressant may be greater than the risks. Just make sure to follow the precautions. Left untreated, depression can cause a number of long-term problems, including suicidal behaviour. For some young people, taking an antidepressant can help ease the symptoms of depression and may reduce the risk of suicide in the long run.


Health Canada has asked drug companies to include a warning in their packaging inserts. It recommends that anyone thinking about using that drug (or any antidepressant) in a child or young adult needs to carefully balance the risk of taking the drug with the need to use it. It also recommends that family members and caregivers closely watch for warning signs of suicide in a child or young adult who takes an antidepressant.

No antidepressants are approved for use in anyone under 18 in Canada. But health professionals often prescribe medicines that are not specifically approved but may still be safe and effective. This is called unlabelled use.


Current as of: October 20, 2022

Author: Healthwise Staff
Medical Review:
John Pope MD - Pediatrics
Kathleen Romito MD - Family Medicine
David A. Axelson MD - Child and Adolescent Psychiatry