New Warnings on Suicidality in Young Adults Taking Antidepre

FDA has proposed that the makers of all antidepressant drugs warn in the product labeling that patients 18 to 24 years old who are on these drugs may be at increased risk for suicidal thinking and suicide attempts. The new warning would be added to the black box section of the label, which already warns about this risk in children and adolescents. The proposed labeling change would also state that the increased risk has not been observed in patients older than 24, and that patients over 65 taking antidepressants actually have a decreased risk of suicidality. The warning also emphasizes that psychiatric disorders themselves are the most important causes of suicide. Affected Products: • 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 oxalate) • 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) Additional Information: FDA MedWatch Safety Alert. Antidepressant Medication Products. May 2, 2007. http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant