In Brief: OTC douche safety/effectiveness
This article was originally published in The Tan Sheet
Executive Summary
OTC douche safety/effectiveness: FDA reopens administrative record of four rulemakings to allow submission of safety and effectiveness data for OTC vaginal douche products, the agency says in a Nov. 19 Federal Register notice. Douche ingredients are regulated under OTC monographs for antifungal, external analgesic, skin protectant and topical antimicrobial products. Submissions to the agency are due Feb. 17. The notice follows a meeting of FDA's Nonprescription Drugs Advisory Committee last spring, when the group concluded existing data from several case-control epidemiological studies show a possible link between the practice of douching and increased risk of pelvic inflammatory disease, ectopic pregnancy and tubal infertility ("The Tan Sheet" April 21, pp. 1-6)...