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FDA Proposed Medication
Guide: 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
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.
Date created: November 03, 2004 |
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