Skip to content

    Depression Health Center

    Font Size
    A
    A
    A

    FDA Orders Strict Antidepressant Warnings

    Makers Now Must Alert Public to Increased Suicide Risk in Kids

    Antidepressant Warning Changes Immediate continued...

    "We continue to believe, however, that these drugs provide significant benefit when used as directed in pediatric patients," says acting FDA Commissioner Lester M. Crawford.

    The agency was criticized in recent weeks by consumer groups and on Capitol Hill because of reports that for months they delayed releasing data on the increased risk of suicidal behavior in users of antidepressants.

    FDA scientists conducting reviews of more than 20 studies found that overall, the antidepressants could be expected to raise suicidal behavior in two to three out of every 100 children who took them. No cases of completed suicide were reported in any of the industry-sponsored trials, however.

    Regulators say they will move to disallow bulk packaging of antidepressant drugs, instead requiring companies to ship them in the same units that are delivered to patients. The action makes it easier to bundle antidepressant warnings with the drugs to ensure they always reach patients, Kweeder says.

    Full List of Antidepressants in WarningAnafranil (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)
    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 (imipramine pamoate)
    Triavil (perphenaine/amitriptyline)
    Vivactil (protriptyline HCl)
    Wellbutrin (bupropion HCl)
    Zoloft (sertraline HCl)
    Zyban (bupropion HCl)

    1 | 2

    Today on WebMD

    contemplation
    Differences between feeling depressed and feeling blue.
    jk rowling
    Famous people who've struggled with persistent sadness.
     
    depressed man sitting on hallway floor
    Learn the truth about this serious illness.
    Sad woman looking out of the window
    Tips to stay the treatment course.
     
    unhappy teen boy
    Health Check
    jk rowling
    Slideshow
     
    Pills with smiley faces
    Article
    Teen girl huddled outside house
    Article
     
    Depressed man sitting in hospital hallway
    Article
    antidepressants slideshow
    Article
     
    pill bottle
    Article
    Winding path
    Article