Antidepressant Suicide Warning for Young Adults
May 2007
Attention anyone 18 to 24 taking Prozac, Paxil, or any antidepressant
drugs – beware of the dangerous risks of suicidal thoughts and behaviors
during initial treatment. The Food and Drug Administration (FDA) has
proposed that every variety of antidepressant medication update their
current black box labels to include warning of heightened risk of
suicide in young adults beginning treatment.
Using post-marketing tracking research, the federal agency decided that the 2005 label changes noting tendency towards suicide for children must now be accompanied by the proposed warning for young adults. Risk of suicide rises in the first few months of antidepressant treatment for patients between the ages of 18 and 24, but does not present an increased risk for those above 24.
All antidepressant medication has been targeted for label changes:
- Anafranil (clomipramine)
- Asendin (amoxapine)
- Aventyl (nortriptyline)
- Celexa (citalopram hydrobromide)
- Cymbalta (duloxetine)
- Desyrel (trazodone HCl)
- Elavil (amitriptyline)
- Effexor (venlafaxine HCl)
- Emsam (selegiline)
- Etrafon (perphenazine/amitriptyline)
- fluvoxamine maleate
- Lexapro (escitalopram hydrobromide)
- Limbitrol (chlordiazepoxide/amitriptyline)
- Ludiomil (maprotiline)
- Marplan (isocarboxazid)
- Nardil (phenelzine sulfate)
- nefazodone HCl
- Norpramin (desipramine HCl)
- Pamelor (nortriptyline)
- Parnate (tranylcypromine sulfate)
- Paxil (paroxetine HCl)
- Pexeva (paroxetine mesylate)
- Prozac (fluoxetine HCl)
- Remeron (mirtazapine)
- Sarafem (fluoxetine HCl)
- Seroquel (quetiapine)
- Sinequan (doxepin)
- Surmontil (trimipramine)
- Symbyax (olanzapine/fluoxetine)
- Tofranil (imipramine)
- Tofranil-PM (imipramine pamoate)
- Triavil (perphenazine/amitriptyline)
- Vivactil (protriptyline)
- Wellbutrin (bupropion HCl)
- Zoloft (sertraline HCl)
- Zyban (bupropion HCl)
The manufacturers of antidepressant drugs now have 30 days to submit revised labels and Medication Guides to reflect the updated warning.
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Source: "FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications." FDA Press Release. May 2, 2007.




