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APA Comments on FDA's First Approval of Medication to Treat Pediatric Schizophrenia and Bipolar Disorder

ARLINGTON, Va., Aug. 22 /PRNewswire-USNewswire/ -- The American Psychiatric Association (APA) applauds the U.S. Food and Drug Administration (FDA) for its review of scientific evidence that led to the approval of a new treatment for two severe psychiatric disorders in children. The APA is pleased that the approvals are a result of the federal Best Pharmaceuticals for Children Act (BCPA), which was designed to encourage research that leads to this kind of approval, given that dosages, side effects and efficacy can vary significantly with children.

"Schizophrenia and bipolar disorder are severely disabling to patients and devastating to their families," said APA President Carolyn Robinowitz, M.D. "For many children suffering with psychiatric illnesses, medications are an important part of a comprehensive treatment program, which should include talk therapy and other interventions."

"For any medication there are benefits and potential risks," said Darrel Regier, M.D., M.P.H., director, APA Division of Research, and executive director, American Psychiatric Institute for Research and Education. "For many children with these disorders, the FDA's action today provides additional information to guide treatment options in these special populations. We anticipate that approval of this medication will encourage federal research agencies to accelerate urgently needed studies of mental disorders in children."

Physicians and parents must work together to evaluate the risks and benefits of any particular treatment. The APA recommends that all treatment for psychiatric illnesses are guided by a thorough evaluation and careful diagnosis, followed up with a treatment plan tailored to the needs of the child and the family.

About the American Psychiatric Association:

The American Psychiatric Association is a national medical specialty society whose more than 38,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders. Visit the APA at and

For Information Contact:

Lydia Sermons-Ward, 703-907-8640

Alissa Schulman, 703-907-8562

SOURCE American Psychiatric Association
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