PEDIATRICS Vol. 83 No. 5 May 1989, pp. 791
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THEOPHYLLINE AND SCHOOL PERFORMANCE

J. F. L. MD

After review of the clinical literature, FDA has concluded, in agreement with its Pulmonary-Allergy Drugs Advisory Committee, that there is insufficient data to state that theophylline produces an adverse effect on the school performance of children. However, the agency encourages further well-controlled studies on this subject.

Agency Review

Because of questions about the methodology used in these studies and the statistical interpretation of the results, in October 1987 FDA's Pulmonary-Allergy Drugs Advisory Committee reviewed all the studies and made recommendations to the agency.

In accordance with the recommendations of this committee and after further agency review, FDA concludes that the present data do not support the conclusion of an adverse effect of theophylline on the performance of school children.

However, consistent with the recommendations of the Advisory Committee, further well-controlled studies are needed. Such studies should include welldefined psychological parameters and be carried out by individuals familiar with the best psychological tests available. The goal of these studies should be to clarify whether any association exists between theophylline and learning behavior or school performance.