Home > Patients & Visitors > Health Library > FDA Advisories for Antidepressants
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.
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.footnote 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.footnote 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
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), with
user-friendly information about suicide risk and precautions that can be taken,
be handed out with each prescription or refill of a medicine.
Although suicidal thoughts and behavior are a risk for an antidepressant, the
FDA 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 behavior. 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 FDA advisory 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
Health Tools help you make wise health decisions or take action to improve your health.
U.S. Food and Drug Administration (2007).
Antidepressant use in children, adolescents, and adults.
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.
ByHealthwise StaffPrimary Medical ReviewerJohn Pope, MD - PediatricsSpecialist Medical ReviewerDavid A. Axelson, MD - Child and Adolescent Psychiatry
Current as ofJuly 26, 2016
Current as of:
July 26, 2016
John Pope, MD - Pediatrics & David A. Axelson, MD - Child and Adolescent Psychiatry
To learn more about Healthwise, visit Healthwise.org.
© 1995-2016 Healthwise, Incorporated. Healthwise, Healthwise for every health decision, and the Healthwise logo are trademarks of Healthwise, Incorporated.
Our interactive Decision Points guide you through making key health decisions by combining medical information with your personal information.
You'll find Decision Points to help you answer questions about:
Get started learning more about your health!
Our Interactive Tools can help you make smart decisions for a healthier life. You'll find personal calculators and tools for health and fitness, lifestyle checkups and pregnancy.
Feeling under the weather?
Use our interactive symptom checker to evaluate your symptoms and determine appropriate action or treatment.