Antidepressant Medications - Box Warning

Bipolar Medications Library

Do you know someone under 25 years of age who takes an antidepressant? Maybe it's you? Maybe it's your child? Then you should know about a warning from the US Food and Drug Administration. This warning is required to be included in the prescribing information that goes to doctors for all antidepressants approved for use by the FDA. A list of the medications that must carry this warning is below.

Full Text of Boxed Warning

WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and 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.

For many antidepressants, the boxed warning includes the following statement: "[Drug Name] is not approved for use in pediatric patients less than 12 years of age." You should always ask your doctor if a proposed antidepressant for your child is approved for use in children.

The Warning in Plain English

Children, teens and young adults up to the age of 24 who were taking antidepressants were studied in clinical trials. The researchers found that some of these young people were more likely to think about suicide or even attempt suicide after they started taking an antidepressant than if they were given a placebo (a pill that looked just like the antidepressant but doesn't contain the drug). It wasn't a huge percentage - if it had been, these drugs would have been sharply restricted or even taken off the market. But there was enough of an increased risk to make this warning necessary.

So it's important that a parent keep a watchful eye on a child who starts taking an antidepressant to look for any unusual behavior changes, and keep in close touch with the prescribing doctor. A young adult outside his or her parents' home needs to be monitored closely by the doctor.

This warning is required on all antidepressants in the United States.

Changes to Patient Medication Guide

In addition to the new box warning on the full prescribing information, changes were made to the patient medication guide that comes with a prescription for an antidepressant. It includes:

• The statement "Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults when the medicine is first started."

• A reminder that people with serious mental illnesses may already be more prone to suicidal thinking and actions.

• Steps to take to watch for and try to prevent suicidal thoughts and actions.

• A list of symptoms that may indicate suicidal thinking.

Complete document (PDF): <a href=http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/ucm100211.pdf]Revisions to Patient Medication Guide

Antidepressants That Must Carry This Warning

• Anafranil (clomipramine HCl)
• Asendin (amoxapine)
• Aventyl (nortriptyline HCl)
• Celexa (citalopram HBr)
• Cymbalta (duloxetine HCl)
• Desyrel (trazodone HCl)
• Effexor (venlafaxine HCl)
• Elavil (amitriptyline HCl)
• Emsam (selegiline)
• Etrafon (perphenazine/amitriptyline)
• Lexapro (escitalopram HBr)
• Limbitrol (chlordiazepoxide/amitriptyline)
• Ludiomil (Maprotiline HCl)
• Luvox (fluvoxamine maleate)
• Marplan (isocarboxazid)
• Nardil (phenelzine sulfate)
• nefazodone HCl
• Norpramin (desipramine HCl)
• Pamelor (nortriptyline HCl)
• Parnate (tranylcypromine sulfate)
• Paxil (paroxetine HCl)
• Pexeva (paroxetine mesylate)
• Prozac (fluoxetine HCl)
• Remeron (mirtazapine)
• Sarafem (fluoxetine HCl)
• Seroquel (quetiapine) - Note: Seroquel is classed as an antipsychotic medication, but it has antidepressant properties
• Sinequan (doxepin HCl)
• Surmontil (trimipramine)
• Symbyax (olanzapine/fluoxetine)
• Tofranil (imipramine HCl)
• Tofranil-PM (imipramine pamoate)
• Triavil (perphenazine/amitriptyline)
• Vivactil (protriptyline HCl)
• Wellbutrin (bupropion HCl) - also sold as Zyban, which also carries the warning
• Zoloft (sertraline HCl)

_{Reference:
Food and Drug Administration. (2007). New Warnings Proposed for Antidepressants}