Health Canada and FDA Advisories for Antidepressants

Health Canada and FDA Advisories for Antidepressants

Topic Overview

Health Canada and FDA advisories. Health Canada and the U.S. Food and Drug Administration (FDA) have issued advisories to patients, families, and health professionals to closely monitor for warning signs of suicidal behaviour in children and adults younger than 25 who take antidepressants. This is especially important at the beginning of treatment or when doses are changed.

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, who are less able to control their impulses and 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.

After reviewing 24 antidepressant trials involving over 4,400 children and teens, the FDA concluded that young people using antidepressants are more likely to report having suicidal thoughts and behaviour. On average, 4 out of 100 children who used an antidepressant reported having suicidal thoughts or behaviour, compared to 2 out of 100 who took a placebo. This means that 96 out of 100 children who used antidepressants did not report having suicidal thoughts or behaviour. The highest risk was during the first few months of treatment. The study found no increase in completed suicides, and no suicides occurred in any of the trials studied.footnote 1

A newer study found that the benefit of taking antidepressants was greater than the risk of suicidal thoughts and behaviour in children and teens.footnote 2

Health Canada has asked drug companies to include a warning in their information package. The warning recommends that anyone considering the use of that drug (or any antidepressant) in patients younger than 18 needs to carefully monitor patients for behavioural and emotional changes, including an increased risk of suicidal thoughts. Monitoring for suicidal thoughts or other signs of potential for suicidal behaviour is advised in patients of all ages. It also recommends that family members and caregivers closely watch for warning signs of suicide in a child or young adult taking an antidepressant. Health Canada requests that this same package warning be handed out with each prescription or refill of 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 that may still be safe and effective. This is called off-label use.

Although suicidal thoughts and behaviour are a risk for an antidepressant, experts recognizes that for many young people, the benefits of antidepressant treatment with proper precautions may be greater than the risks. Left untreated, depression can cause a number of long-term consequences, including suicidal behaviour. For some young people, taking an antidepressant can help ease the symptoms of depression and may actually reduce the risk of suicide in the long run.

If your child is currently taking an antidepressant, watch carefully for warning signs, especially during the first few weeks of treatment. If you are concerned about the advisories or about warning signs of suicide, contact your child's doctor.

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



  1. U.S. Food and Drug Administration (2007). Antidepressant use in children, adolescents, and adults. Available online:
  2. Bridge JA, et al. (2007). Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials. JAMA, 297(15): 1683–1695.


Current as of: June 16, 2021

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