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© 2004 American Academy of Pediatrics

NEWS AND FEATURES

Advice for treating children with antidepressants

Lynn Wegner, M.D., FAAP, chair of the AAP Section on Developmental and Behavioral Pediatrics, offers the following advice to clinicians treating pediatric patients who are considering or are currently taking antidepressants. The following suggestions are not approved AAP policy. The Academy is working with the American Psychiatric Association, American Academy of Child and Adolescent Psychiatry and the American Academy of Family Physicians to develop a joint advisory that will be issued to pediatricians and other physicians in the next several months.

Before you prescribe

• Depression is characterized by both internalizing symptoms expressed by the child (e.g., mood, feeling of guilt, being criticized by others) and externalizing symptoms observed by parents and teachers (withdrawal, irritability, and changes in appetite and sleep). Once symptoms have been identified, physicians should verify the symptoms are sustained, neurovegetative and interfere with several domains of functioning (poor sleep, appetite).
• When providing a full suicide assessment, questions should be asked directly of the child, family members, friends and teachers, if possible. Questions should identify previous self-destructive thoughts and attempts. The child should be asked for all of the "reasons for living" he/she can articulate.
• Provide a complete physical exam to eliminate any confounding/co-morbid physical elements.
• Ask parents/caregivers to remove weapons from the home, particularly guns, and any medications that should not be accessible to the child.
• After discussing with the patient and guardian the risks and benefits of treatment, obtain informed consent for medication use. Physicians should keep a printed form or handwritten/dictated note of informed consent from the guardians and have it clearly documented in the child's medical records. The clinician also should have established a plan with the referral psychiatrist (if available) should self-destructive actions occur to assure timely intervention.

Children on antidepressant medications

• Tools such as the Beck Depression Inventory and Children's Depression Inventory-Revised may be used to monitor the child's response to treatment. While rating scales are not definitive for diagnosing depression, they can help guide questions during follow-up monitoring appointments. Suicide should be discussed at each visit. Although the greatest risk appears to be in the first 40 days after diagnosis and medical treatment initiation, the clinician must explore this topic regularly.

As the Academy and other groups formulate appropriate monitoring guidelines for primary care physicians, Dr. Wegner offers the following suggestions, based on her experience:

• Newly diagnosed children: Parents and child should have a telephone number where they can reach a clinician 24/7 if they have any concerns about the child appearing more despondent, irritable, etc. The child should be seen in the office approximately weekly for weeks 1-4, then biweekly for the next two months. After 12 weeks, office visits should be every three months or sooner if needed.
• Children who require dosage changes: Advise the parents to observe changes in mood/behavior and either have office appointments or telephone confirmation once weekly for one month, then office appointments once every three months.
• Children on medication 12 weeks or longer: Children who have been taking antidepressants for 12 weeks or longer and do not require dosage changes should be seen in the office every three months.

Language of FDA's 'black box' warning
Suicidality in Children and Adolescents
Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Drug Name] is not approved for use in pediatric patients except for patients with [Any approved pediatric claims here]. (See Warnings and Precautions: Pediatric Use)

Pooled analysis of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

Antidepressants drugs with black box warning label

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