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]
» Drug Warnings and Withdrawls for 2007 from PharmaGazette
FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products. The list is based on 2006 worl... [Read More]
Tracked on: December 5, 2007 2:41 PM | Permalink to Trackback