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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)

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