Executive Summary

VAGINAL SPERMICIDE LABEL IRRITATION WARNING SHOULD BE "ENHANCED" to caution that frequent use may lead to irritation, FDA's Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective Drugs and Antiviral Drugs Advisory Committees concluded at a Nov. 20-22 joint meeting in Gaithersburg, Md. The group, however, did not specify the rate of spermicide use that should be avoided. The joint advisory committee was presented at the meeting with data showing that irritation is observed with the use of vaginal spermicides, but the cause of the irritation is unclear ("The Tan Sheet" Nov. 25, p. 1).