Ortho-McNeil Pharmaceutical Inc announced U.S. Food and Drug Administration (FDA) approval for the first birth control patch, Ortho Evra (norelgestromin/ethinyl estradiol transdermal system).
Approximately 38 million American women currently use some form of birth control. However, a recent national survey found that more than 75 per cent of women say there is a need for methods that are more adaptable to their lives.
Ortho Evra is a thin, beige patch that delivers continuous levels of the hormones norelgestromin and ethinyl estradiol (progestin and estrogen, respectively) through the skin and into the bloodstream. The patch is worn for one week and replaced on the same day of the week for three consecutive weeks. The fourth week is "patch-free".
Women can wear Ortho Evra discreetly on one of four areas of the body: the buttocks, abdomen, upper torso (front and back, excluding the breasts) or upper outer arm. Studies show that Ortho Evra remains attached and effective while bathing, swimming, exercising or wearing it in humid conditions. In clinical studies, less than two percent of patches had to be replaced because of complete detachment and less than three percent had to be replaced because of partial detachment.
Phase III clinical trials involved more than 3,300 women for more than 22,000 menstrual cycles. One of these studies, which were published earlier this year in the Journal of the American Medical Association (JAMA), found that Ortho Evra was as effective in preventing pregnancy as a leading birth control pill.
Ortho Evra is indicated for the prevention of pregnancy. Ortho Evra is not for everyone. Women should speak with their healthcare professional about which birth control method is right for them.
The contraceptive patch contains hormones similar to those in birth control pills. Hormonal contraceptives are not for everybody. Most side effects of the contraceptive patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke or heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use hormonal contraceptives are strongly advised not to smoke. Some women should not use the contraceptive patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The contraceptive patch does not protect against HIV or other sexually transmitted diseases.
Ortho Evra was developed by the R. W. Johnson Pharmaceutical Research Institute and is marketed by Ortho-McNeil Pharmaceutical Inc. Ortho-McNeil Pharmaceutical is a pioneer in contraception and a leader in women's health care. Ortho-McNeil offers the broadest range of prescription birth control options, including nine birth control pills, a leading intrauterine device (IUD), diaphragms and now the first birth control patch.