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Dec 5
FDA Updates Black Box Warning for Antidepressants

In May, 2007 the U. S. Food and Drug Administration updated the black box warning on 36 antidepressants to include the increased risk of suicidal thinking and behavior, known as suicidality, in young adults between the ages of 18 and 24 during intital treatment, generally the first one or two months.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

 

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)

[Source: U.S. Food and Drug Administration]


2 Comments/Trackbacks




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