FDA Public Health Advisory
Suicidality in Children and Adolescents Being
Treated With Antidepressant Medications
October 15, 2004
Today the Food and Drug Administration (FDA) directed manufacturers of all
antidepressant drugs to revise the labeling for their products to include a
boxed warning and expanded warning statements that alert health care providers
to an increased risk of suicidality (suicidal thinking and behavior) in children
and adolescents being treated with these agents, and to include additional
information about the results of pediatric studies. FDA also informed these
manufacturers that it has determined that a Patient Medication Guide (MedGuide),
which will be given to patients receiving the drugs to advise them of the risk
and precautions that can be taken, is appropriate for these drug products.
These labeling changes are consistent with the recommendations made to the
Agency at a joint meeting of the Psychopharmacologic Drugs Advisory Committee
and the Pediatric Drugs Advisory Committee on September 13-14, 2004.
The drugs
that are the focus of this new labeling language are all drugs included in
the general class of antidepressants; they are listed at the end of this
Advisory.
The risk of suicidality for these drugs was identified in a combined
analysis of short-term (up to 4 months) placebo-controlled trials of nine
antidepressant drugs, including the selective serotonin reuptake inhibitors
(SSRIs) and others, in children and adolescents with major depressive disorder
(MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders.
A total of 24 trials involving over 4400 patients were included. The analysis
showed a greater risk of 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.
Based on these data, FDA has determined that the following points are appropriate
for inclusion in the boxed warning:
- Antidepressants increase the risk of suicidal thinking and behavior (suicidality)
in children and adolescents with MDD and other psychiatric disorders.
- Anyone considering the use of an antidepressant in a child or adolescent
for any clinical use must balance the risk of increased suicidality 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 to closely observe the patient
and to communicate with the prescriber.
- A statement regarding whether the particular drug is approved for any
pediatric indication(s) and, if so, which one(s).
Among the antidepressants, only Prozac is approved for use in treating MDD
in pediatric patients. Prozac, Zoloft, Luvox, and Anafranil are approved for
OCD in pediatric patients. None of the drugs is approved for other psychiatric
indications in children.
Pediatric patients being treated with antidepressants
for any indication should be closely observed for clinical worsening, as
well as agitation, irritability, suicidality, and unusual changes in behavior,
especially during the initial few months of a course of drug therapy, or at
times of dose changes, either increases or decreases. This monitoring should
include daily observation by families and caregivers and frequent contact with
the physician. It is also recommended that prescriptions for antidepressants
be written for the smallest quantity of tablets consistent with good patient
management, in order to reduce the risk of overdose.
In addition to the boxed
warning and other information in professional labeling on antidepressants,
MedGuides are being prepared for all of the antidepressants to provide information
about the risk of suicidality in children and adolescents directly to patients
and their families and caregivers. MedGuides are intended to be distributed
by the pharmacist with each prescription or refill of a medication.
FDA plans
to work closely with the manufacturers of all approved antidepressant products
that are the subject of today"s letters to optimize the safe
use of these drugs and implement the proposed labeling changes and other safety
communications in a timely manner. The labeling changes at issue will be posted
on FDA's website http://www.fda.gov/cder/drug/antidepressants/default.htm.
- Anafranil (clomipramine HCl)
- Aventyl (nortriptyline
HCl)
- Celexa (citalopram HBr)
- Cymbalta (duloxetine HCl)
- Desyrel (trazodone HCl)
- Effexor
(venlafaxine HCl)
- Elavil (amitriptyline HCl)
- Lexapro (escitalopram oxalate)
- Limbitrol
(chlordiazepoxide/amitriptyline)
- Ludiomil
(Maprotiline HCl)
- Luvox (fluvoxamine maleate)
- Marplan (isocarboxazid)
- Nardil
(phenelzine sulfate)
- Norpramin (desipramine HCl)
- Pamelor (nortriptyline HCl)
- Parnate (tranylcypromine sulfate)
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- Paxil (paroxetine HCl)
- Pexeva
(paroxetine mesylate)
- Prozac
(fluoxetine HCl)
- Remeron (mirtazapine)
- Sarafem (fluoxetine HCl)
- Serzone (nefazodone HCl)
- Sinequan (doxepin HCl)
- Surmontil (trimipramine)
- Symbyax (olanzapine/fluoxetine)
- Tofranil (imipramine HCl)
- Tofranil-PM (impiramine pamoate)
- Triavil (Perphenaine/Amitriptyline)
- Vivactil (protriptyline HCl)
- Wellbutrin (bupropion HCl)
- Zoloft (sertraline HCl)
- Zyban (bupropion HCl)
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Date created: October 15, 2004, updated May 2, 2007 |