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ACNP Task Force Report on SSRIs and Suicidal Behavior in Youth

Neuropsychopharmacology volume 31, pages 473492 (2006) | Download Citation

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Abstract

This Task Force report by the American College of Neuropsychopharmacology evaluates the safety and efficacy of selective serotonin reuptake inhibitor (SSRIs) antidepressants for depressed youth under 18 years. The report was undertaken after regulatory agencies in the United States and United Kingdom raised concerns in 2003 about the possibility that treatment of depression in children and adolescents with SSRIs may increase the risk of suicidal thinking or suicide attempts.

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Author information

Affiliations

  1. Columbia University/New York State Psychiatric Institute, New York, NY, USA

    • J John Mann
    •  & David Shaffer
  2. The University of Texas Southwestern Medical Center, Dallas, TX, USA

    • Graham Emslie
  3. McLean Hospital, Belmont, MA, USA

    • Ross J Baldessarini
  4. Harvard Medical School/Boston Children's Hospital, Boston, MA, USA

    • William Beardslee
  5. University of New Mexico School of Medicine, Santa Fe, NM, USA

    • Jan A Fawcett
  6. George Washington University Medical Center, Washington, DC, USA

    • Frederick K Goodwin
  7. Weill Medical College of Cornell University, New York, NY, USA

    • Andrew C Leon
  8. Vanderbilt University Medical Center, Nashville, TN, USA

    • Herbert Y Meltzer
  9. Western Psychiatric Institute & Clinic, University of Pittsburgh, Pittsburgh, PA, USA

    • Neal D Ryan
  10. University of Texas Medical Branch, Galveston, TX, USA

    • Karen D Wagner

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  11. Search for Karen D Wagner in:

Corresponding author

Correspondence to J John Mann.

Appendices

Appendix 1

FDA Labeling Change Request Letter for Antidepressant Medications http://www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm (Updated, October 28, 2004)

‘Suicidality in Children and Adolescents

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of (Drug Name) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. (Drug Name) is not approved for use in pediatric patients except for patients with (Any approved pediatric claims here). (See Warnings and Precautions: Pediatric Use)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.’

The website also requests other changes in the following sections:

  • WARNINGS—Clinical Worsening and Suicide Risk

  • Tapering (for those drugs for which tapering is recommended)

  • PRECAUTIONS—Information for Patients

  • Pediatric Use

Appendix 2

FDA Proposed Medication Guide: About Using Antidepressants in Children or Teenagers http://www.fda.gov/cder/drug/antidepressants/SSRIMedicationGuide.htm (Date created: November 3, 2004)

‘The FDA has written a proposed Medication Guide about Using Antidepressants in Children or Teenagers and sent this Medication Guide to all the sponsors on October 21, 2004. It appears here to inform other groups and individuals with an interest in this Medication Guide. The FDA hopes to finalize the language of this Medication Guide by December 2004 so that the Medication Guide can be produced and made available to patients by the end of January 2005’.

What is the most important information I should know about antidepressants?

Parents or guardians need to know about four important things to help them decide whether their child or teenager should take an antidepressant:

□ The risks of self-injury or suicide

□ How to try to prevent self-injury or suicide

□ What to watch for in children or teens taking antidepressants

□ The benefits and risks of antidepressants

1. Risk of Injury to Self or Suicide

Children or teenagers with depression sometimes think about suicide. They may even try to kill themselves. Antidepressants may increase suicidal thoughts or actions in some children and teens. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.

A large study combined the results of 24 different smaller studies of children and teenagers who took either sugar pills or antidepressants for 1 to 4 months. Although no one committed suicide in these studies, some young patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 young patients became suicidal.

2. How to try to prevent self-injury or suicide

To try to prevent self-injury and suicide in children and teens using antidepressants, everyone (patients, parents, teachers, and other important people in the lives of young people) should pay close attention to sudden changes in their moods or behaviors. These are listed below under ‘What to Watch For’. Whenever an antidepressant is started or its dose is changed, close attention is needed.

In general, after starting an antidepressant, patients should see their doctor

  • Once a week for four weeks

  • Every 2 weeks for the next month

  • At the end of their 12th week taking the drug

  • More often if problems or questions arise (see other side)

3. What to Watch Out For in Children or Teens Taking Antidepressants

If any of the following behaviors appear for the first time, seem worse, or worry the child, parent, or guardian, a medical professional should be contacted right away.

□ New or more thoughts of suicide

□ Trying to commit suicide

□ New or worse depression

□ New or worse anxiety

□ Feeling very agitated or restless

□ Panic attacks

□ Difficulty sleeping (insomnia)

□ New or worse irritability

□ Acting aggressive, being angry, or violent

□ Acting on dangerous impulses

□ Being extremely hyperactive in actions and talking (hypomania or mania)

□ Other unusual changes in behavior

4. The Benefits and Risks of Antidepressants

Antidepressants are used to treat people with depression. Depression can lead to suicide. In some people, treatment with an antidepressant causes suicidal thinking or actions or makes them worse. The doctor, the patient, and the patient's parents or guardians should discuss all treatment choices, including the use of antidepressants.

Of all antidepressants, only fluoxetine (brand name: Prozac) has been FDA approved to treat pediatric depression.

For obsessive compulsive disorder, FDA considers only fluoxetine (brand name: Prozac), sertraline (brand name: Zoloft), fluvoxamine (no marketed brand name product), and clomipramine (brand name: Anafranil) to be of proven benefit in children and teens.

The past experiences of the patient with other treatments or antidepressants may lead the doctor to suggest other antidepressants than the ones listed above.

For some young people, the risks of suicidal behaviors caused by antidepressants may be especially high. These include young people with

□ Bipolar illness (sometimes called manic-depressive illness)

□ A family history of bipolar illness

□ A personal or family history of attempting suicide

If any of these are present, make sure the doctor knows about them before the doctor prescribes any antidepressant.

Is this all I need to know about antidepressants?

‘No. This is a general warning for all antidepressants about suicidality. Other side effects can occur with antidepressants. Be sure to ask the doctor to explain all the side effects of the particular drug you are taking. Ask your pharmacist where to find additional information.’

American College of Neuropsychopharmacology Task Force on SSRIs and Suicidal Behavior

Task Force Members and Disclosures

J John Mann, MDTask Force Co-ChairThe Paul Janssen Professor of Translational Neuroscience in Psychiatry and Radiology, Columbia University College of Physicians and SurgeonsChief, Department of Neuroscience,New York State Psychiatric InstituteACNP

Industry Affiliations:

  • Consultant: GlaxoSmithKline, Pfizer, 2001 (expert trial witness)

  • Grants/Research Support: PET ligand development grant from Pfizer (2003), Beta-amyloid imaging grant from GlaxoSmithKline (2005)

  • Attended a 2002 GlaxoSmithKline Advisory group meeting on lamotrigine

Graham Emslie, MDTask Force Co-ChairChief, Division of Child and Adolescent Psychiatry and Professor of Psychiatry,The University of Texas Southwestern Medical Center at DallasACNP

Industry Affiliations:

  • Consultant/Speaker's Bureau: Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, McNeil, Otsuka, Pfizer, Inc. Wyeth-Ayerst

  • Grants/Research Support: Eli Lilly, Novartis, Organon

Ross J Baldessarini, MDProfessor of Psychiatry and Neuroscience, Harvard Medical SchoolDirector, Laboratories for Psychiatric Research, Mailman Research CenterDirector, Bipolar & Psychiatric Disorders/Director, Psychopharmacology, McLean HospitalACNP

Industry Affiliations:

  • Consultant/Research Collaborator: Auritec Laboratories, Eli Lilly Laboratories, IFI SpA, Janssen Pharmaceuticals, JDS Corporation, NeuroHealing Pharmaceuticals

  • Grants/Research Support: Eli Lilly Laboratories (former grant recipient), Janssen Pharmaceuticals

(continued)

Task Force Members and Disclosures

(continued)

William Beardslee, MDPsychiatrist-in-Chief and Chair, Children's Hospital Department of PsychiatryProfessor of Child Psychiatry, Harvard Medical School

No Industry Affiliations

Jan Fawcett, MDProfessor of Psychiatry, University of New MexicoACNP

Industry Affiliations:

  • Consultant: Abbott Laboratories, Bristol-Myers Squibb, Eli Lilly and Company, Forest Laboratories, Janssen Pharmaceutica, GlaxoSmithKline, Merck & Co. Inc., Pfizer, Inc., Pharmacia & Upjohn, Wyeth-Ayerst Laboratories

  • Speaker's Bureau: Abbott Laboratories, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer/Roerig, Pharmacia, GlaxoSmithKline, Solvay Pharmaceuticals, Inc., Wyeth-Ayerst Laboratories

  • Grants/Research Support: National Institute of Mental Health, Abbott Laboratories, Astra Zeneca Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly and Company, Organon, Pfizer, Inc., Wyeth-Ayerst Laboratories

Fred Goodwin, MDResearch Professor of Psychiatry and Director, Psychopharmacology Research Center, George Washington UniversityACNP

Industry Affiliations:

  • Consultant: Glaxo, Lilly, Pfizer, Bristol Myers Squibb, Solvay. Elan, Novartis

  • Speakers Bureau: Bristol Myers Squibb, Solvay, Glaxo, Pfizer, Janssen, Lilly, AstraZeneca, Grants/Research Support: Abbott Laboratories, Glaxo, Solvay, Janssen, Pfizer, Lilly, Forest, Sanofi,

(continued)

Task Force Members and Disclosures

(continued)

Andrew C Leon, PhDProfessor of Biostatistics in Psychiatry and Professor of Public Health,Weill Medical College of Cornell University.

Industry Affiliations:

  • Consultant: Cyberonics, Inc., Cortex Pharmaceuticals, Pfizer.

Herb Meltzer, MDProfessor of Psychiatry & Pharmacology, Director Division of PsychopharmacologyPresident, Collegium Internationale Neuropsychopharmacologicum (CINP),Vanderbilt University Medical CenterACNP

Industry Affiliations:

  • Consultant, Speaker's Bureau, Honorarium, Grant/Research Support: Eli Lilly, Pfizer, GlaxoSmithKline, Janssen, AstraZeneca

Neal Ryan, MDProfessor of Psychiatry, Western Psychiatric Institute & Clinic, University of PittsburghACNP

Industry Affiliations:

  • Consultant: GlaxoSmithKline (designed study and a performance site for the GSK study of paroxetine in adolescents and was second author on the resulting publication as well as a co-author on related letters to the editor including one letter related to suicidality assessment in that study)

  • Consultant: GlaxoSmithKline (examination of their data related to suicidality in their aggregate paroxetine data.)

  • Consultant (design of studies of antidepressants in youth): Pfizer, GSK, and Wyeth

  • Primary Investigator: Wyeth (Pittsburgh performance site for the study of Venlafaxine and children.)

(continued)

Task Force Members and Disclosures

(continued)

David Shaffer, MDProfessor of Child Psychiatry, and Professor of Psychiatry and Pediatrics,Columbia University College of Physicians and SurgeonsDirector, Division of Child Psychiatry, New York State Psychiatric Institute

Industry Affiliations:

  • Consultant: Hoffman la Roche, Wyeth (expert trial witness)

  • Consultant: GlaxoSmithKline (on the matter of paroxetine and adolescent suicide)

Karen Wagner, MD, PhDDirector, Division of Child and Adolescent Psychiatry,Professor and Vice Chair, Department of Psychiatry and Behavioral Sciences,University of Texas Medical Branch, GalvestonACNP

Industry Affiliations:

  • Consultant: Abbott Laboratories, Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest Laboratories, Glaxo-Smith Kline, Janssen, Novartis, Otskua, Pfizer, UCB Pharma, Wyeth-Ayerst

  • Speaker's Bureau: Abbott Laboratories, Eli Lilly and Co., Forest Laboratories, Glaxo-Smith Kline, Janssen, Novartis, Pfizer Inc.

  • Advisory Board: Abbott Laboratories, Eli Lilly and Co., Forest Laboratories, Glaxo-Smith Kline, Janssen, Novartis, Otsuka, Pfizer, UCB Pharma, Wyeth-Ayerst

  • Research Support: Abbott, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Organon, Pfizer, Wyeth-Ayerst, National Institute of Mental Health

Assistance in writing the executive summary was provided by medical writer Miriam Davis, PhD, LLC, Adjunct Assistant Professor, Department of Epidemiology and Biostatistics, School of Public Health and Health Services, George Washington University.

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DOI

https://doi.org/10.1038/sj.npp.1300958