Other proposed changes would include a statement that scientific data does not show an increased risk for adults over 24 and that adults 65 and older actually have a decreased risk. The label would also emphasize that depression itself is an important cause of suicide.
This labeling update follows a similar change made in 2005 when the FDA asked manufacturers to add a black box warning regarding suicidality in children and adolescents.
The FDA cautions that people who are currently taking an antidepressant should not stop. Any concerns that you feel regarding the labeling changes should be addressed to your personal physician.
The proposed changes would apply to all antidepressants since insufficient data exists to exclude any individual drugs.
Drugs which are included in this latest action include:
- 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)
