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.