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To the Editor.—I am concerned about the recommendations which appear in the literature for the use of imipramine in nocturnal enuresis. It has been recommended that this drug be used in children under 12. It has been stated that the efficacy is almost 100% in this age group. Referral to the package insert of this drug states that the use is not established as safe for children under 12 years of age. Under my current understandings of the Federal Drug Administration regulations, when this is the case, one needs an investigator's license, in order to use the drug. I think this point should be made in the articles which recommend that the drug be used in children. If any side effect occurs in a child under 12 years of age, the physician is, by this very fact, guilty of negligence.
Commissioner Goddard of the Federal Drug Administration has recently
HEALY CE. IMIPRAMINE AND ENURESIS. Am J Dis Child. 1967;114(6):704. doi:10.1001/archpedi.1967.02090270160028