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FDA: Antidepressant Use in Children, Adolescents, and Adults
By FDA
May 4, 2007 - 8:23:14 PM

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1. What is FDA announcing regarding the use of antidepressants?

FDA is announcing a request to manufacturers of all antidepressant medications to update the existing “black box” on their product labeling to include warnings about increased risks of suicidal thinking and behavior (suicidality) in young adults ages 18 to 24 during initial treatment.

The labeling also will point out that scientific data did not show this increased risk in adults older than 24 and that adults ages 65 and older taking antidepressants actually have a decreased risk of suicidality. The warning statements will emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

Drug manufacturers will have 30 days to submit their revised labeling and revised Patient Medication Guides to the FDA for review.  Medication Guides are FDA-approved user-friendly information for patients, families and caregivers that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

2. Why is FDA making this announcement now?

In December 2006, the FDA’s Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants.  Additionally, the committee recommended that product labeling note that no increased risk of suicidality was seen in adults older than 24 and that adults ages 65 and older taking antidepressants actually had a decreased risk of suicidality. Finally, the committee recommended that labeling remind health care professionals that depression and other disorders being treated with these drugs are serious illnesses that need to be recognized and effectively treated.    

3. What products are involved in this announcement of a labeling change?

The requested labeling changes apply to the entire category of antidepressants. Products involved in today’s 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), and Zyban (bupropion HCl).

4. Are the drugs mentioned above approved for use in children and adolescents?

Prozac (fluoxetine) is approved for use in children and adolescents for the treatment of major depressive disorder. Prozac (fluoxetine), Zoloft (sertraline), and fluvoxamine maleate are approved for use in children and adolescents for the treatment of obsessive compulsive disorder. The other drugs have no approved uses in children.

5. I am currently taking an antidepressant. What should I do?

If you observe worsening depression, or the emergence of suicidal thinking, or if you are experiencing other symptoms that you are concerned might be related to taking your medication, you should consult your doctor to discuss the best course of action.  It is very important that you do not stop taking your antidepressant without first checking with your doctor. Also, some of these medications may be associated with discontinuation symptoms if stopped abruptly. If your doctor advises that your medication should be stopped, be sure to follow your doctor’s advice about how to accomplish this.

6. My child or adolescent, or someone else I am caring for, is currently taking an antidepressant. What should I do?

If you observe worsening depression, or the emergence of suicidal thinking, or if you observe other symptoms that you are concerned might be related to taking medication, you should consult the doctor responsible for your child’s or this person’s medications to discuss the best course of action. It is very important that you do not stop your child’s or this person’s antidepressant without first checking with the prescribing doctor. Also, some of these medications may be associated with discontinuation symptoms if stopped abruptly, so that, if the doctor advises that the medication should be stopped, be sure to follow the doctor’s advice about how to accomplish this.

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"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."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's 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)