Ortho Evra Contraceptive PatchThe only currently available contraceptive patches are the Ortho Evra, marketed in the United States by Ortho-McNeil, and Evra marketed in Canada by Janssen-Ortho and in the United Kingdom and other countries by Janssen-Cilag. The Ortho Evra patches are packaged in boxes of three and are only available by prescription. The contraceptive patch is often informally referred to as "the Patch". Like all combined hormonal contraceptives, Ortho Evra and Evra works primarily by preventing ovulation. Another mechanism of action is the inhibition of sperm penetration by changes in the cervical mucus. Hormonal contraceptives also have effects on the endometrium that also could affect implantation; however, no strong evidence indicates that prevention of implantation actually results from their use. In studies with oral contraceptives, the risk for heart disease is significantly increased in women over 35 years of age who also smoke tobacco. Therefore, Ortho Evra's package insert states that "Women who use hormonal contraceptives, including ORTHO EVRA, should be strongly advised not to smoke cigarettes". According to the manufacturer, the patches introduce a 60% higher level of estrogen into the bloodstream as compared to oral contraceptives; however, the clinical significance of this difference is unknown. On November 10, 2005, Ortho Evra McNeil, in conjunction with the FDA, revised the label for Ortho Evra, including a new warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing estrogen, noting that higher levels of estrogen may put some women at increased risk for getting blood clots. The label was again revised in September of 2006, and on January 18, 2008, the FDA again updated the label to reflect study results. "The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options." |
|
Donate Car Education Finance Insurance Legal Medical |