PEDIATRICS Vol. 83 No. 5 May 1989, pp. A77
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THEOPHYLLINE AND SCHOOL PERFORMANCE

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.