FDA Medication Guide Antidepressants 2007-08-15 U.S.A. ++Guide to Be Given by Pharmacies to All Parents/Guardians of Those Under 18


Medication Guide
Antidepressant Medicines, Depression and other
Serious Mental Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide that comes with your or your family member’s antidepressant
medicine. This Medication Guide is only about the risk of suicidal thoughts
and actions with antidepressant medicines. Talk to your, or your family member’s,
healthcare provider about:
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant
medicines, depression and other serious mental illnesses, and suicidal thoughts or
1.Antidepressant medicines may increase suicidal thoughts or actions in some
children, teenagers, and young adults within the first few months of treatment.
2.Depression and other serious mental illnesses are the most important causes
of suicidal thoughts and actions. Some people may have a particularly high risk
of having suicidal thoughts or actions.
These include people who have (or have a
family history of) bipolar illness (also called manic-depressive illness) or suicidal
thoughts or actions.
3.How can I watch for and try to prevent suicidal thoughts and actions in myself
or a family member?
• Pay close attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is very important when an antidepressant
medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in
mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the
healthcare provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member has any of the
following symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry,
or violent
• acting on dangerous impulses
• an extreme increase in activity and
talking (mania)
• other unusual changes in behavior
or mood
What else do I need to know about antidepressant medicines?
Never stop an antidepressant medicine without first talking to a healthcare
Stopping an antidepressant medicine suddenly can cause other
Antidepressants are medicines used to treat depression and other illnesses.
It is important to discuss all the risks of treating depression and also the risks
of not treating it. Patients and their families or other caregivers should discuss
all treatment choices with the healthcare provider, not just the use of
Antidepressant medicines have other side effects. Talk to the healthcare
provider about the side effects of the medicine prescribed for you or your
family member.
Antidepressant medicines can interact with other medicines. Know all of the
medicines that you or your family member takes. Keep a list of all medicines to
show the healthcare provider. Do not start new medicines without first checking
with your healthcare provider.
Not all antidepressant medicines prescribed for children are FDA approved for
use in children.
Talk to your child’s healthcare provider for more information.
This Medication Guide has been approved by the U.S. Food and Drug Administration
for all antidepressants.
Revised 8/2007