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APA and the American Academy of Child and Adolescent Psychiatry (AACAP) recently applauded the new federal requirement mandating pediatric studies of approved drugs and recommended about 25 drugs be tested.
The FDA responded favorably to the recommendations by APA and AACAP and included most of the drugs in its draft list distributed for comment in March, according to a joint APA/AACAP letter to the FDA last month.
APA President Herbert S. Sacks, M.D., commented to Psychiatric News, "We jointly suggested to the FDA that five drugs (buspirone, carbamezapine, guanfacine, nortriptyline, and propranotol) be reconsidered for acceptance and that a further review of the evidence-based literature is merited. Furthermore, some drugs may have been omitted from the draft list because they have clear indications for adults but there isn't enough data yet to support off-label use in children."
For example, guanfacine is an adult hypertensive, but it is used in children and adolescent for attention/deficit hyperactivity disorder, according to the April letter.
Sacks explained that APA and the academy first commented on the FDA draft list of drugs in February, after consulting with the Office of Research and the Council on Children, Adolescents, and Families, and gaining significant input from child and adolescent psychopharmacologists.
The list submitted to the FDA Center for Evaluation and Research includes methylphenidate, fluoxetine, sertraline, bupropion, lithium, valproate, clozapine, and risperidone. Anxiolytic and tricyclic drugs were also listed.
The FDA Modernization Act signed into law last year by President Clinton requires the FDA to consult with experts in pediatric research and develop, prioritize, and publish a list of approved drugs for which additional pediatric information may produce health benefits in this population.
Sacks commented, "We are concerned about clinicians prescribing medications including psychotropics for uses and indications that are not appropriately evidence based. Adult dosages may be inappropriately prescribed in children, whose obvious weight difference and developmental stage should be taken into account."
The two organizations emphasized that their recommended list is not meant to be all-inclusive, but encompasses those drugs considered a high priority because of their current level of use in children.
Moreover, because all new antidepressants and antipsychotropics introduced in the last 10 years for adults are also used in children, "pediatric studies should be done not only to assess safety and efficacy, but also to generate specific pediatric labeling information," according to the joint February letter.