PEDIATRICS Vol. 46 No. 3 September 1970, pp. 473
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SULFONAMIDE COMBINATIONS: RECENT FDA ACTION

COMMITTEE ON DRUGS

Charles F. Weiss M.D., Sumner J. Yaffe M.D., Howard M. Cann M.D., Arnold P. Gold M.D., Frederic M. Kenny M.D., Harris D. Riley Jr. M.D., Irwin Schafer M.D., Leo Stern M.D., and Harry C. Shirkey M.D.

The Committee on Drugs of the American Academy of Pediatrics has transmitted the following letter to the Federal Food and Drug Administration on the recent action by that agency regarding the use of sulfonamide combinations in pediatrics.

Your letter of September 12, 1969, regarding the role of systemic sulfonamides in the treatment of infections, has resulted in many comments being directed to the committee on Drugs of the American Academy of Pediatrics. Consequently, this matter was discussed during the Committee meeting held on October 20 and 21, 1969, in chicago. After careful and extensive review, the Committee wishes to express the following comments.

Sulfonamides have been shown to be of value in the treatment of certain infectious diseases in children, including acute otitis media, and penicillin and sulfonamides are generally recognized in combination as effective therapy in this common disorder. In young children where a high incidence of infection due to H. influenzae has been demonstrated, the usefulness of this combination is confirmed by the widespread clinical experience of Academy members, as well as by certain published controlled clinical studies.

While meningitis due to H. influenzae is included as an approved indication for sulfonamide therapy (reference your letter, Item 9), the Committee on Drugs regards the omission of otitis media as a serious error. As you know, otitis due to H. influenzae is often a precursor of meningitis in small children. Both of these infections are indications for the adjunctive use of sulfonamides, and to restrict its use to one is illogical and contrary to good medical practice.