FDA Approves Contraceptive for Continuous Use
The Food and Drug Administration (FDA) today approved Lybrel, the first continuous use drug product for prevention of pregnancy. The safety and efficacy of Lybrel as a contraceptive method were supported by two one-year clinical studies, enrolling more than 2,400 women, ages 18 to 49. Health care professionals and patients are advised that when considering the use of Lybrel, the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting. However, as this product will be used for decades long term effects, if any, have not had an oppodtunity to develop.