October 15, 2004
Jim Wood, Director Development and Communications
202.966.7300, ext. 120, firstname.lastname@example.org
Mary Crosby, Deputy Executive Director, Director of Government Affairs
202.966.7300, ext. 127, email@example.com
The American Academy of Child and Adolescent Psychiatry (AACAP) will work with the Food and Drug Administration (FDA) on today's announced multi-pronged strategy to strengthen safeguards for children treated with antidepressant medications.
The AACAP has been a leader in working for the safe and effective use of medications when treating children and adolescents with mental illnesses, even though it did not support the use of a "black box" warning on the prescriptions, urging stronger label warnings instead. Even so, the AACAP applauds the careful consideration the FDA has shown in issuing the new warning with accompanying directives for more physician and patient information about side-effects and monitoring. The AACAP agrees with the FDA's call for inclusion in the boxed warning of additional information about the results of newly analyzed pediatric studies on 4,400 children and adolescents in 24 studies involving 9 different antidepressants. Also supported is the Patient Medication Guide (MedGuide), which will be given to patients receiving the medications.
The FDA followed the AACAP's recommendation for giving parents specific warning signs of antidepressant side effects, with the emphasis on balancing the serious impairments of untreated depression against the newly discovered low risk of suicidal thoughts, as well as the need for more research on the long term effectiveness of antidepressants. In its earlier comments to the FDA, AACAP President Richard Sarles, wrote, "Patients and families should receive a written list of symptoms, such as increased suicidal ideas or ruminations or the impulse to hurt oneself. During the monitoring contacts, the physician should ask the patient and the family about any new or increased suicidal ideation and the occurrence of self-harm events, particularly with any intent to die."
With ten percent of children and adolescents living with a mental illness, and over 2.5 percent of them affected by depression, there is a critical need for more treatment options, not fewer. Suicide is the third leading cause of death in adolescents, but the numbers have declined in recent years, possibly because of the use of antidepressants. There is also a need for more health care professionals, such as child and adolescent psychiatrists, to be trained to treat individuals under age 18, but until that shortage is addressed, many families must rely on non-psychiatrists for treatment.
AACAP members are child and adolescent psychiatrists, who are trained to use medications and therapy in treating mental illnesses, and who understand the development of treatment plans that include therapy and, if necessary, medication. There is still concern that other practitioners will not accept pediatric patients who have depression or will restrict the use of medications because of the warning. In this regard, the AACAP has already begun the process of providing its members with updated practice guidelines, is working with the American Psychiatric Association to develop a practice advisory, and is continuing its work with the AMA on removing research bias and allowing access to all clinical data. The AACAP is meeting in Washington, DC, and depression will be a major topic of discussion over five days of an extensive scientific program. A pressroom will be available to the media.
The AACAP plans to work closely with members, colleagues and families to use the new FDA warnings to improve treatment planning and monitoring, to work with the National Institute of Mental Health to increase and improve research into the disorders of childhood and adolescence, and to work for an increase in the number of child and adolescent psychiatrists.
For additional information see the following AACAP resources:
Children and Antidepressant Medication
Facts for Families on medications:
No. 21. Psychiatric Medication For Children and Adolescents Part 1: How Medications Are Used. November 1999.
No. 29. Psychiatric Medication For Children and Adolescents Part 2: Types of Medications. February 2000.
No. 51. Psychiatric Medication For Children and Adolescents Part 3: Questions to Ask. March 2001.
Policy Statements on medications:
Prescribing Psychoactive Medication for Children and Adolescents (2001) (PS-41)