Prescribers or other health professionals should inform patients, their families, and their caregivers about the
benefits and risks associated with treatment with DESYREL and should counsel them in its appropriate use. A patient
Medication Guide About Using Antidepressants in Children and Teenagers is available for DESYREL. The prescriber or
health professional should instruct patients, their families, and their caregivers to read the Medication Guide and
should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of
the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide
is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking
Clinical Worsening and Suicide Risk:
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor
restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation,
especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of
patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be
abrupt. Such symptoms should be reported to the patients prescriber or health professional, especially if they are
severe, abrupt in onset, or were not part of the patients presenting symptoms. Symptoms such as these may be
associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring
and possibly changes in the medication.
Because priapism has been reported to occur in patients receiving DESYREL, patients with prolonged or
inappropriate penile erection should immediately discontinue the drug and consult with the physician.
Antidepressants may impair the mental and/or physical ability required for the performance of potentially
hazardous tasks, such as operating an automobile or machinery; the patient should be cautioned accordingly.
DESYREL may enhance the response to alcohol, barbiturates, and other CNS depressants.
DESYREL should be given shortly after a meal or light snack. Within any individual patient, total drug absorption
may be up to 20% higher when the drug is taken with food rather than on an empty stomach. The risk of
dizziness/lightheadedness may increase under fasting conditions.
About Using Antidepressants in Children and Teenagers
What is the most important information I should know if my child is being prescribed an
Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:
- There is a risk of suicidal thoughts or actions
- How to try to prevent suicidal thoughts or actions in your child
- You should watch for certain signs if your child is taking an antidepressant
- There are benefits and risks when using antidepressants
1. There is a Risk of Suicidal Thoughts or Actions
Children and teenagers sometimes think about suicide, and many report trying to kill themselves.
Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and
actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants.
Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.
A large study combined the results of 24 different studies of children and teenagers with depression or other
illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months.
No one committed suicide in these studies, but some patients became suicidal. On sugar
pills, 2 out of every 100 became suicidal. On the ant idepressants, 4 out of every 100 patients became suicidal.
For some children and teenagers, the risk of suicidal actions may be especially high.
These include patients 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 you tell your healthcare provider before your child takes an
2. How to Try to Prevent Suicidal Thoughts and Actions
To try to prevent suicidal thought and actions in your child, pay close attention to changes in her or his moods
or actions, especially if the changes occur suddenly. Other important people in your childís life can he lp by
paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes
to look out for are listed in Section 3, on what to watch for.
Whenever an antidepressant is started or its dose is changed, pay close attention to your child.
After starting an antidepressant, your child should generally see his or her healthcare provider:
- Once a week for the first 4 weeks
- Every 2 weeks for the next 4 weeks
- After taking the antidepressant for 12th weeks
- After 12 weeks, follow your healthcare providerís advice about how often to come back
- More often if proble ms or questions arise
You should call your childís healthcare provider between visits if needed.
3. You Should Watch For Certain Signs If Your Child is Taking an Antidepressant
Contact your childís healthcare provider right away if your child exhibits any of the following signs for
the first time, or if they seem worse, or worry you, your child, or your childís teacher:
- Thoughts about suicide or dying
- Attempts 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
- An extreme increase in activity and talking
- Other unusual changes in behavior or mood
Never let your child stop taking an antidepressant without first talking to his or healthcare provider. Stopping
an antidepressant suddenly can cause other symptoms.
4. There are Benefits and Risks When Using Antidepressants
Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to
suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It
is important to discuss all the risks of treating depression and also the risks of not treating it. You and your
child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
Other side effects can occur with antidepressants.
Of all antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.
For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®),
sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).
Your healthcare provider may suggest other antidepressants based on the past experience of your child or other
Is this all I need to know if my child is being prescribed an antidepressant?
No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure
to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also
ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more
Prozac® is a registered trademark of Eli Lilly and Company
Zoloft® is a registered trademark of Pfizer Pharmaceuticals
Anafranil® is a registered trademark of Mallinckrodt Inc.
This Medication Guide has been approved by the U. S. Food and Drug Administration for all antidepressants.
Revised January 26, 2005