Warning for Young Adults Taking Antidepressants
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:
For more information:
Antidepressant use in children, adolescents, and adults, including the draft
labeling and draft Medication Guides www.fda.gov/cder/drug/antidepressants/default.htm
FDA's Psychopharmacologic Drugs Advisory Committee, including transcripts
from the December 2006 meeting www.fda.gov/ohrms/dockets/ac/cder06.html#Psychopharmacologic
Source: FDA Press Release #P07-77, May 2, 2007
Last Editorial Review: 5/3/2007
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