The Safety and Efficacy of the Estrogen Patient Package Insert

Abstract

IN MARCH 1975, several consumer organizations petitioned the Food and Drug Administration, requesting that written information containing pertinent warnings be included with certain prescription drugs. Following solicitation of comments from interested persons (American Medical Association and consumer groups), the FDA issued a regulation,¹effective October 1977, requiring distribution of a patient package insert (PPI) with all estrogenic drug products. Excluded were estrogen-containing oral contraceptives, for which a PPI has existed since 1970, and diethylstilbestrol products intended for postcoital contraception. According to J. Richard Crout, MD, director of the Bureau of Drugs of the FDA, "These [estrogen agents] were chosen because they are used by normal women as contraceptive and postmenopausal agents for which reasonable alternatives exist."²The current PPI must additionally be distributed to all women receiving postpartum estrogen therapy for suppression of lactation. Few studies have evaluated patients' interest in PPIs. Joubert and Lasagna³assessed the