In January 2008, the US Food and Drug Administration (FDA) approved changes to the label of the Ortho Evra® Contraceptive Transdermal Patch. The new label includes the results of an epidemiology study, which found that users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills. The blood clots, known as venous thromboembolism (VTE), can lead to pulmonary embolism, a condition that develops when an artery in the lung is blocked by a blood clot that traveled there from elsewhere in the body.
The study was conducted by the Boston Collaborative Drug Surveillance Program on behalf of Ortho McNeil Pharmaceuticals, the division of Johnson & Johnson that manufactures the patch. The study targeted women aged 15–44 who are using the patch. These findings confirm results from a 2006 study conducted by i3 Ingenix that reported the risk of VTE for women in this age group using the birth control patch is approximately twice as high as that of women in the same age group taking the pill.
The Ortho Evra prescription patch releases ethinyl estradiol, an estrogen hormone, and norelgestromin, a progestin hormone, directly into the bloodstream through the skin. The body processes the hormones in the patch differently than it does when they are in pill form. Women using the patch are exposed to about 60% more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. These increased levels of estrogen may increase the risk of side effects, including VTE.
“For women that choose to use contraceptives, it is important that they thoroughly discuss with their healthcare providers the risks and benefits involved,” says Janet Woodcock, MD, the FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.
According to the FDA, Ortho Evra is a safe and effective method of contraception when used according to the labeling.
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