Abstract

PIP: In 1993, the Food and Drug Administration (FDA) issued new labeling guidelines for oral contraceptives, intrauterine devices (IUDs), implantable and injectable contraceptives, and natural membrane condoms. The prevalence of sexually transmitted diseases (STDs) and the AIDS epidemic prompted the FDA to take this action as part of an on-going education effort to reduce the risk in sexually active individuals, particularly adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults, are continuing to engage in high-risk sexual behavior. The required statement for oral contraceptives, subdermal implants, injectables, and IUDs is: "This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases." For latex condoms the message reads: "If used properly, latex condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." For female condoms the label reads: "If you are not going to use a male latex condom, you can use a female condom to help protect yourself and your partner." The message on latex condoms will appear on individual condom wrappers as well as on the outer package. Manufacturers will add a similar statement to patient and physician leaflets provided with the products. Other contraceptives that may be relabeled in the future include spermicides, cervical caps, diaphragms, and the contraceptive sponge. The new contraceptive labeling effort is part of a broader initiative of the US Public Health Service regarding women's health that focuses on health issues and diseases in women, including reproductive disorders, breast and other cancers, and substance abuse.