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FDA Advisories for Antidepressants

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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.

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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.

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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.
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