Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Prozac and should counsel them in its appropriate use. A patient Medication Guide About Using Antidepressants in Children and Teenagers is available for Prozac. 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 Prozac.
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 Prozac may impair judgment, thinking, or motor skills, patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected.
Patients should be advised to inform their physician if they are taking or plan to take any prescription or over-the-counter drugs, or alcohol.
Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
Patients should be advised to notify their physician if they are breast-feeding an infant.
Patients should be advised to notify their physician if they develop a rash or hives.
About Using Antidepressants in Children and Teenagers
What is the most important information I should know if my child is being prescribed an antidepressant?
Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:
1. There is a risk of suicidal thoughts or actions
2. How to try to prevent suicidal thoughts or actions in your child
3. You should watch for certain signs if your child is taking an antidepressant
4. 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 antidepressants, 4 out of every 100 patients became suicidal.
For some children and teenagers, the risks 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 health care provider before your child takes an antidepressant.
2. How to Try to Prevent Suicidal Thoughts and Actions
To try to prevent suicidal thoughts 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 childs life can help 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 health care provider
· Once a week for the first 4 weeks
· Every 2 weeks for the next 4 weeks
· After taking the antidepressant for 12 weeks
· After 12 weeks, follow your health care providers advice about how often to come back
· More often if problems or questions arise
You should call your childs health care provider between visits if needed.
3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant
Contact your childs health care 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 childs 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 her health care 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 health care provider, not just the use of antidepressants.
Other side effects can occur with antidepressants.
Of all the 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 health care provider may suggest other antidepressants based on the past experience of your child or other family members.
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 health care 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 health care provider or pharmacist where to find more information.
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.
Do not take this medicine with thioridizine, or within 5 weeks of taking fluoxetine.
Talk to your doctor if you are taking certain antibiotics such as erythromycin, clarithromycin
or azithromycin. This medicine should not be taken with MAO inhibitors.
Caution should be exercised when taking this medicine certain antibiotics, such as erythromycin,
clarithromycin, or azithromycin. This medicine should not be taken with MAO inhibitors. If you
think you are taking an MAO inhibitor talk to your doctor or pharmacist. Do not take this medicine
with St. Johns Wort because of the additive effects of sertonin.
This medication should not be taken with MAO inhibitors. Your doctor or pharmacist can give you more information
on MAO inhibitors. Wait 5 weeks after stopping escitalopram before starting a non-selective MAO inhibitor. Wait 2
weeks after stopping an MAO inhibitor before starting escitalopram.
If you are taking medications for migraines such as Imitrex, talk to your doctor before starting this medicine.
If you are taking a tricyclic antidepressant, talk to your doctor before taking this medicine.
St. Johns Wort should be avoided while taking this medicine due to the additive effects of serotonin.
Tell your doctor if you are taking any of the following drugs:
blood thinners (Coumadin)
birth control pills
Prozac is contraindicated in patients known to be hypersensitive to it.
Monoamine oxidase inhibitors ¾ There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued fluoxetine and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Prozac should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks [perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses ] should be allowed after stopping Prozac before starting an MAOI.
Thioridazine ¾ Thioridazine should not be administered with Prozac or within a minimum of 5 weeks after Prozac has been discontinued .