FDA Proposed Medication
Guide:
About Using Antidepressants in Children or Teenagers
The FDA has written a proposed Medication Guide about
Using Antidepressants in Children or Teenagers and sent this
Medication Guide to all the sponsors on October 21, 2004. It appears
here to inform other groups and individuals with an interest in this
Medication Guide. The FDA hopes to finalize the language of this
Medication Guide by December 2004 so that the Medication Guide can be
produced and made available to patients by the end of January 2005.
What is the most important information I should know
about antidepressants?
Parents or guardians need to know about four important
things to help them decide whether their child or teenager should take
an antidepressant:
The risks of self-injury or suicide
How to try to prevent self-injury or suicide
What to watch for in children or teens taking
antidepressants
The benefits and risks of antidepressants
1. Risk of Injury to Self or Suicide
Children or teenagers with depression sometimes think
about suicide. They may even try to kill themselves. Antidepressants
may increase suicidal thoughts or actions in some children and teens.
Thinking about killing yourself or trying to kill yourself is called
suicidality or being suicidal.
A large study combined the results of 24 different
smaller studies of children and teenagers who took either sugar pills
or antidepressants for 1 to 4 months. Although no one
committed suicide in these studies, some young patients became
suicidal. On sugar pills, 2 out of every 100 became suicidal. On the
antidepressants, 4 out of every 100 young patients became suicidal.
2. How to try to prevent self-injury or suicide
To try to prevent self-injury and suicide in children
and teens using antidepressants, everyone (patients, parents,
teachers, and other important people in the lives of young people)
should pay close attention to sudden changes in their moods or
behaviors. These are listed below under “What to Watch For.” Whenever
an antidepressant is started or its dose is changed, close attention
is needed.
In general, after starting an antidepressant, patients
should see their doctor
-
Once a week for four weeks
-
Every 2 weeks for the next month
-
At the end of their 12th week taking the drug
-
More often if problems or questions arise (see other
side)
3. What to Watch Out For in Children or
Teens Taking Antidepressants
If any of the following behaviors appear for the first
time, seem worse, or worry the child, parent, or guardian, a medical
professional should be contacted right away.
New or more thoughts of suicide
Trying to commit suicide
New or worse depression
New or worse anxiety
Feeling very agitated or restless
Panic attacks
Difficulty sleeping (insomnia)
New or worse irritability
Acting aggressive, being angry, or violent
Acting on dangerous impulses
Being extremely hyperactive in actions and talking
(hypomania or mania)
Other unusual changes in behavior
4. The Benefits and Risks of Antidepressants
Antidepressants are used to treat people with
depression. Depression can lead to suicide. In some people, treatment
with an antidepressant causes suicidal thinking or actions or makes
them worse. The doctor, the patient, and the patient's parents or
guardians should discuss all treatment choices, including the use of
antidepressants.
Of all antidepressants, only fluoxetine (brand name:
Prozac) has been FDA approved to treat pediatric depression.
For obsessive compulsive disorder, FDA considers only
fluoxetine (brand name: Prozac), sertraline (brand name: Zoloft),
fluvoxamine (no marketed brand name product), and clomipramine (brand
name: Anafranil) to be of proven benefit in children and teens.
The past experiences of the patient with other
treatments or antidepressants may lead the doctor to suggest other
antidepressants than the ones listed above.
For some young people, the risks of suicidal behaviors
caused by antidepressants may be especially high. These include
young people with
Bipolar illness (sometimes called manic-depressive
illness)
A family history of bipolar illness
A personal or family history of attempting suicide
If any of these are present, make sure the doctor
knows about them before the doctor prescribes any antidepressant.
Is this all I need to know about antidepressants?
No. This is a general warning for all antidepressants
about suicidality. Other side effects can occur with antidepressants.
Be sure to ask the doctor to explain all the side effects of the
particular drug you are taking. Ask your pharmacist where to find
additional information.
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Date created: November 3, 2004, updated May 2, 2007 |