Oral contraceptive labeling disclosure of possible benefits.

Oral contraceptive (OC) labeling disclosure of possible benefits from use of the products, was recommended by the U.S. Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee at its February 11 meeting. Committee member Howard Orr, Centers for Disease Control, noting the emphasis on cautionary and warning statements contained in current OC labeling maintained: "Women should make informed decisions and this is the other half. The package insert must include the benefits information." The recommendation by the committee represents a shift in the approach to what constitutes proper labeling for OC products. Since first approved, the drugs have never carried a discussion of benefits on their labels. "A number of additional benefits from OCs--other than contraception--have emerged from the large number of studies recorded in the literature on OC use," Ron Nelson, White Memorial Medical Center, stated. "Studies cited a more regular and lighter menstrual flow, resulting in less blood loss and lower iron deficiency and anemia in contraceptive pill users, and dysmenorrhea and premenstrual tension have been sifnificantly reduced." "Ovarian cysts and pelvic inflammatory disease occurred less frequently in pill users than in controls," Nelson continued, "and the incidence of fibrocystic disease of the breast were less. There are some instances where OCs may incur protection against the development of ovarian cancer, endometrial cancer, and rheumatoid arthritis." Orr added: "I think there are 2 good studies that show almost a total elimination of ectopic pregnancy with women who took the pill. Given that now there's an epidemic of the disease going around, I think it's worth adding." The committee was asked by FDA last November to recommend changes in the current physician and patient OC labeling. FDA's Solomon Sobel, MD, Endocrine and Metabolic Drugs Division, told the committee that an agency subcommittee would review the recommendations, present them to the committee in May for final comment, then publish them in the Federal Register.