Skip to content

FDA Advisories for Antidepressants

Font Size

Topic Overview

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

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, who are less able to control their impulses and may be at greater risk for suicidal behaviors.

Recommended Related to Depression

Cognitive Behavioral Therapy for Depression

Cognitive behavioral therapy (CBT) is an effective treatment for depression. At the heart of CBT is an assumption that a person's mood is directly related to his or her patterns of thought. Negative, dysfunctional thinking affects a person's mood, sense of self, behavior, and even physical state. The goal of cognitive behavioral therapy is to help a person learn to recognize negative patterns of thought, evaluate their validity, and replace them with healthier ways of thinking. At the same time,...

Read the Cognitive Behavioral Therapy for Depression article > >

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.

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 behavior. On average, 4 out of 100 children who used an antidepressant reported having suicidal thoughts or behavior, 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 behavior. 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.1

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

The FDA has asked drug companies to include in their packaging inserts a "black box" warning, the government's strongest medication warning. The warning, appearing in bold letters inside a black box, recommends that anyone considering the use of 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 taking an antidepressant.

1|2

WebMD Medical Reference from Healthwise

Last Updated: May 03, 2013
This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.
Next Article:

FDA Advisories for Antidepressants Topics

Hot Topics

WebMD Video: Now Playing

Click here to wach video: Dirty Truth About Hand Washing

Which sex is the worst about washing up? Why is it so important? We’ve got the dirty truth on how and when to wash your hands.

Click here to watch video: Dirty Truth About Hand Washing

Popular Slideshows & Tools on WebMD

MS Overview
Recognizing symptoms.
feet
Solutions for 19 types.
pregnancy test and calendar
Helping you get pregnant.
build a better butt
How to build a better butt.
lone star tick
How to identify that bite.
woman standing behind curtains
How it affects you.
brain scan with soda
Tips to avoid complications.
row of colored highlighter pens
Tips for living better.
stressed working woman
And how to fix them?
woman dreaming
What Do Your Dreams Say About You?
spinal compression fracture
Treatment options.

Women's Health Newsletter

Find out what women really need.