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Sept. 21, 2004 — The American Psychiatric Association (APA) released the
following statement today in response to the recent Food and Drug Administration
(FDA) hearing on antidepressant use in pediatric patients and further
appropriate warnings:
The American Psychiatric Association commends the
Food and Drug Administration, and in particular its Psychopharmacologic Drugs
Advisory Committee and its Pediatric Advisory Committee, for its public hearing
on safe antidepressant use in pediatric patients. The APA believes the hearing,
held Sept. 13-14, was inclusive and thorough, and based on science and concern
for patients and parents.
The APA also commends the advisory committees
for recommending that the FDA maintain access to antidepressant medications. As
part of a comprehensive treatment plan, antidepressants can be extremely helpful
and even lifesaving for many young people struggling with depression, an illness
with significant long-term consequences, including an increased risk for
suicide. We believe the biggest threat to a depressed child’s well-being is to
receive no care at all.
The APA supports the advisory committees’
recommendation that the FDA maintain access to a full range of antidepressants.
As we stated during our testimony, the latest research indicates that between 30
percent and 40 percent of young people with depression will not respond to an
initial medication. However, many of these patients will ultimately respond to a
different medication. It is essential that physicians be able to utilize the
full range of medications.
We believe that, by calling attention to the
need for caution in prescribing antidepressants in this population and by
calling for more research, the FDA has provided a valuable service in protecting
the safety of the public while enhancing the knowledge base. The APA is hopeful
that the hearing serves patients by adding to the dialogue between physicians,
patients and families.
It is key to note that the advisory committee’s
recommendation for “black box” warnings was adopted by a split vote, with 15
committee members in favor and eight opposed. The APA believes that several
dissenters’ concerns that such warnings will limit access to care are valid and
should be taken into account by the FDA as it proceeds.
The APA believes
the advisory committees have established a strong case for closer monitoring of
patients with depression, especially vulnerable youngsters. The APA will look
for continued opportunities to offer expert clinical advice to the FDA as it
considers further appropriate warnings for antidepressants. In addition, we will
work with physicians — including pediatricians and general practitioners — to
help them better understand their patients’ needs and properly monitor
patients.
David Fassler, M.D., an APA trustee who is a practicing child
and adolescent psychiatrist in Vermont, delivered oral testimony at the FDA
hearing on behalf of the APA. The APA’s director of research, Darrel A. Regier,
M.D., M.P.H., analyzed all current, publicly available research on SSRI
antidepressants, especially with respect to their use in treating pediatric
depression, which is the basis for the written statement APA submitted to the
FDA.
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