FDA Proposes New Warnings About Young Adults Taking Antidepr

FDA Proposes New Warnings About Young Adults Taking Antidepressants

ROCKVILLE, MD -- May 2, 2007



-- The 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, MD,
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:




Quote:





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)