The U.S. Food and Drug Administration (FDA) has approved the first contraceptive patch for use on a weekly basis.
The three-layer, combination, transdermal patch, Ortho Evra, contains 6.00 mg of norelgestromin and 0.75 mg of ethinyl estradiol, releasing 150 mcg and 20 mcg, respectively, into the blood stream every 24 hours. The patch is applied on the same day each week for three consecutive weeks to the buttocks, abdomen, upper torso (front or back, but not breasts), or upper outer arm. The fourth week is patch-free. Results of clinical studies demonstrate a low rate of premature detachment of the patches, and the patches were found to be durable while bathing, swimming, or exercising.
Pregnancy rates from three large, worldwide trials involving 3,300 women who completed 22,155 cycles of the patch were approximately one per 100-women years of use. Of the 15 pregnancies reported, five occurred in women who weighed 198 lb (90 kg) or more (less than 3 percent of the study population), indicating the patch may be less effective in this group of women. The most common adverse events reported included breast symptoms, headache, patch-site irritation, and nausea. It is strongly recommended that women who use the patch quit smoking. As with other combination hormonal contraceptives, the patch is not recommended for use by women who have blood clots, certain cancers, a history of heart attack or stroke, or those who may be pregnant. The patch does not provide protection against sexually transmitted diseases or human immunodeficiency virus, and is not indicated for use as an emergency contraceptive.
Ortho Evra is scheduled to be released to consumers by prescription during the first half of 2002. Additional information is available at http://www.orthoevra.com.
COPYRIGHT 2002 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group