Learn why antidepressants have warnings about suicidal thinking in children and teens, what to do before your child starts taking an antidepressant, and the warning signs of a potential problem.By Mayo Clinic Staff
Antidepressant drugs are often an effective way to treat depression and anxiety in children and teenagers. However, antidepressant use in children and teens must be monitored carefully, as rarely there can be severe side effects.
Antidepressants carry a Food and Drug Administration (FDA) black box warning about a risk of increased suicidal thinking and behavior in some individuals under the age of 25.
Although at first you may find the suicide warnings alarming, it's important to get the facts. Find out what the warnings mean and ask about all treatment options. This will help you make an informed decision about your child's health and weigh the benefits and risks of treatment options with your child's doctor.
The FDA reported that an extensive analysis of clinical trials showed that antidepressants may cause or worsen suicidal thinking or behavior in a small number of children and teens. The analysis showed that children and teens taking antidepressants had a small increase in suicidal thoughts, compared with those taking a sugar pill (placebo).
None of the children in any of the studies actually took his or her own life. Still, the FDA considered the findings concerning enough to issue a public health advisory and require manufacturers to label antidepressants with strong warnings about the link to suicidal thinking and behavior in children, adolescents and young adults under 25.
However, not all mental health researchers believe these warnings are necessary. Newer research indicates that the benefits of antidepressants may be greater than the risk of suicide. And some research indicates that suicide rates in children decrease when they take antidepressants.
Although the FDA analysis examined only nine antidepressants, the FDA extended the warning to all prescription antidepressants. This black box warning is the strongest safety warning that the FDA can issue about a prescription drug. The warning is printed in bold type framed in a black border at the top of the paper inserts that come with antidepressants.
Because of the risk of suicide from depression, it's difficult to establish a clear causal relationship between antidepressant use and suicide. Researchers speculate about a variety of potential reasons for an increased risk. In some children, antidepressants may also trigger anxiety, agitation, hostility, restlessness or impulsive behavior. These effects may indicate that the child's depression is getting worse or that the child is starting to develop suicidal thoughts.
The warnings about a possible link between antidepressants and suicidal thoughts do not mean that antidepressants should not be used in children. Nor are the warnings meant to frighten people away from antidepressants. However, the warnings should be taken as a caution to carefully weigh the pros and cons of using antidepressants in children and teenagers against the real risk of suicide as a result of untreated depression.
For many children and teens, antidepressants are an effective way to treat depression, anxiety, obsessive-compulsive disorder or other mental health conditions. If these conditions aren't treated effectively, your child may not be able to lead a satisfying, fulfilled life or do normal, everyday activities.
It's important that your child have a thorough evaluation before he or she starts taking an antidepressant. A psychiatric evaluation by a psychiatrist — or a pediatrician or family physician who is experienced in the treatment of child and adolescent mood disorders — should include:
- A detailed review of any potential risk factors your child may have that increase the risk of self-harm
- An assessment of whether your child may have other mental illnesses, such as anxiety disorders, attention-deficit/hyperactivity disorder or bipolar disorder
- An evaluation of whether there's a family history of mental illnesses or suicide
The FDA has approved certain antidepressants for use in children and teenagers for different types of diagnoses. Antidepressants come with a medication guide that advises parents and caregivers about risks and precautions. Be sure to carefully read the medication guide and package insert, and discuss any questions with the prescribing physician and your pharmacist.
FDA-approved antidepressants for children and teenagers
||Age (in years)
|*Many of these drugs are also available in generic form. Recommended initial dose and maximum dose vary by age.
||10 and older
||Obsessive-compulsive disorder (OCD)
||7 and older
||Generalized anxiety disorder
||12 and older
||Major depressive disorder
||8 and older
||Major depressive disorder
|7 and older
||8 and older
|Olanzapine and fluoxetine, combination drug (Symbyax)
||10 and older
||6 and older
Antidepressants can also be used for other conditions. The antidepressant imipramine (Tofranil) is approved by the FDA to treat daytime or nighttime involuntary urination (childhood enuresis) in children 6 years of age and older.
Physicians may use their medical judgment to prescribe other antidepressants for children for what's called off-label use. This is a clinically common practice for many types of medications for both children and adults.
The FDA advises that doctors prescribe the smallest quantity of pills possible to help reduce the risk of deliberate or accidental overdose. Careful monitoring by parents, caregivers and health care professionals is important for any child or teenager taking an antidepressant for depression or any other condition.
The highest risk of suicidal thinking and behavior occurs:
- During the first few months of treatment with an antidepressant
- When the dosage is increased or decreased
Parents and caregivers should closely observe the child on a daily basis during these transition periods and watch for worrisome changes for the whole time the child takes antidepressants.
The FDA also recommends that your child receive close monitoring by a health care professional during the first few months of treatment, and ongoing monitoring throughout treatment. Frequency of contact with doctors or mental health professionals depends on your child's needs. Make sure you stick to your child's recommended appointment schedule.
Sometimes the signs and symptoms of suicidal thoughts or self-harm are difficult to see, and your child may not directly tell you about such thoughts. Here are some signs that your child's condition may be worsening or that he or she may be at risk of self-harm:
- Talk of suicide or dying
- Suicide attempts
- Agitation or restlessness
- New or worsening anxiety or panic attacks
- Increasing sadness or worsening of depression symptoms
- Extreme increase in talking, energy or activity
- Aggression, violence or hostility
- Trouble sleeping or worsening insomnia
- Spending more time alone
Contact your child's health care professional right away if any of these signs occur, if they get worse, or if they worry you, your child, a teacher or other caregiver.
Make sure your child doesn't stop antidepressant treatment without the guidance of the prescribing doctor. Suddenly stopping an antidepressant may cause flu-like symptoms, an increase in anxiety and other side effects referred to as discontinuation syndrome. Stopping too suddenly may also result in the return of depression symptoms.
Most children who take antidepressants for depression will improve with medication. However, combining medication with talk therapy (psychotherapy) is likely to be even more effective. Many types of psychotherapy may be helpful, but cognitive behavioral therapy and interpersonal therapy have been scientifically studied and shown to be effective for treating depression.
- Cognitive behavioral therapy. In cognitive behavioral therapy, a mental health professional can help your child improve coping skills, communication and problem-solving skills. Your child can also learn how to become aware of harmful ideas and behaviors, replace them with positive approaches, and manage emotions.
- Interpersonal therapy. With a focus on relationships, this therapy may help your teenager adapt to changes in current relationships and develop new ones.
For some children and teenagers with mild symptoms, talk therapy alone may be beneficial.
June 25, 2019
- Pediatric antidepressant fact sheet. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Pharmacy-Education-Materials/antidepressant-education.html. Accessed April 29, 2019.
- Revisions to product labeling. U.S. Food and Drug Administration. https://www.fda.gov/media/77404/download. Accessed April 29, 2019.
- Strawn JR, et al. Efficacy and tolerability of antidepressants in pediatric anxiety disorders: A systematic review and meta-analysis. Depression and Anxiety. 2015;32:149.
- Suicidality in children and adolescents being treated with antidepressant medications. U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/suicidality-children-and-adolescents-being-treated-antidepressant-medications. Accessed April 29, 2019.
- Cipriani A, et al. Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: A network meta-analysis. The Lancet. 2016;388:881.
- Cooper WO, et al. Antidepressants and suicide attempts in children. Pediatrics. 2014;133:204.
- Pediatric antidepressant dosing chart. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Pharmacy-Education-Materials/antidepressant-education.html. Accessed April 29, 2019.
- Locher C, et al. Efficacy and safety of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and placebo for common psychiatric disorders among children and adolescents: A systematic review and meta-analysis. JAMA Psychiatry. 2017;74:1011.
- Hussain H, et al. Recent developments in the treatment of major depressive disorder in children and adolescents. Evidence-Based Mental Health. 2018;21:101.
- Symbyax (prescribing information). Indianapolis, Ind.: Eli Lilly and Company; 2017. https://www.lilly.com/Products/Human/From-Our-History.aspx. Accessed April 30, 2019.
- FDA: Don't leave childhood depression untreated. U.S. Food and Drug Administration. http://www.fda.gov/forconsumers/consumerupdates/ucm413161.htm. Accessed April 29, 2019.
- Gibbons RD, et al. Antidepressant treatment and suicide attempts and self-inflicted injury in children and adolescents. Pharmacoepidemiology and Drug Safety. 2015;24:208.
- Zuckerbrot RA, et al. Guidelines for adolescent depression in primary care (GLAD-PC): Part 1. Practice preparation, identification, assessment, and initial management. Pediatrics. 2018;141:e20174081.
- Cheung AH, et al. Guidelines for adolescent depression in primary care (GLAD-PC): Part II. Treatment and ongoing management. Pediatrics. 2018;141:e20174082.
- Gabriel M, et al. Antidepressant discontinuation syndrome. CMAJ. 2017;189:E747.
- Suicidal behavior. MentalHealth.gov. https://www.mentalhealth.gov/what-to-look-for/suicidal-behavior. Accessed April 29, 2019.
- Anafranil (prescribing information). Whitby, Ontario: Patheon Inc.; 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4074b555-7635-41a9-809d-fae3b3610059. Accessed May 21, 2019.
- Cymbalta (prescribing information). Indianapolis, Ind.: Eli Lilly and Company; 2017. http://uspl.lilly.com/cymbalta/cymbalta.html. Accessed May 21, 2019.
- Fluvoxamine maleate (prescribing information). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=85b61f83-ab47-470d-8673-02fea29247be. Parsippany, N.J.: Actavis Pharma, Inc.; 2017. Accessed May 21, 2019.
- Lexapro (prescribing information). Madison, N.J.: Allergan Inc.; 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a. Accessed May 21, 2019.
- Prozac (prescribing information). Indianapolis, Ind.: Eli Lilly and Company; 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299. Accessed May 21, 2019.
- Zoloft (prescribing information). New York, N.Y.: Pfizer Inc.; 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=92278f12-0f00-4c0b-bb44-c6dd2dbb5b6c. Accessed May 21, 2019.
- Tofranil (prescribing information). Whitby, Ontario; Patheon Inc.; 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1827a5aa-733a-49d9-89d9-48ea0367b230. Accessed May 24, 2019.
- Krieger CA (expert opinion). Mayo Clinic, Rochester, Minn. June 19, 2019.
- McKean AJ (expert opinion). Mayo Clinic, Rochester, Minn. June 12, 2019.