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FDA Advisories for Antidepressants

Overview

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

The FDA also advises 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 behaviors in children. That's because children are less able to control their impulses. They may be at greater risk for suicidal behaviors.

The FDA has 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 FDA advisory 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 behavior are a risk for an antidepressant. But the FDA recognizes that for many young people, the benefits of taking an antidepressant may be greater than the risks. Just make sure to follow the FDA's precautions. Left untreated, depression can cause a number of long-term problems, including suicidal behavior. 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.

Actions

The FDA has asked drug companies to include in their packaging inserts a "black box" warning. This is the government's strongest medicine warning. The warning is in bold letters inside a black box. 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.

The black box warning notes the drug's approved uses. Right now, only certain antidepressants are approved for use in children and teens. But other antidepressants are commonly used. Health professionals often prescribe medicines that are not specifically approved but may still be safe and effective. This is called unlabeled use.

The FDA also requests that a Patient Medication Guide (MedGuide) be handed out with each prescription or refill of a medicine. This guide has user-friendly information about suicide risk and the precautions you can take.

Credits

Current as of: February 9, 2022

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