Ortho Evra Users - The Verdict Is In!
Friday, January 18, 2008
Ijeoma Eleazu, PharmD
The FDA today announced that it has approved that Ortho McNeil, the manufacturer of the Ortho Evra Contraceptive Transdermal Patch make some changes to the medication's label. The label will now include results of a new study that found that women who use this particular patch are truly at a higher risk for developing serious blood clots (venous thromboembolism aka VTE), than those who take birth control pills.
The study was done in women between the ages of 15 and 44 and the findings support an earlier study conducted by Ingenix which came to the same conclusion back in September 2006. Although this new study, conducted by the Boston Collaborative Drug Surveillance Program (BCDSP), does not specify exactly how much greater risk users of the Ortho Evra patch are at, the Ingenix study put the increased risk at double that of women taking the pill.
Because the patch is worn on the skin, it takes a different journey through the body than does the pill (which is obviously taken by mouth) and the main difference in the end result of their "journeys" is that the patch exposes women to roughly 60% more estrogen than the pill does; increased levels of estrogen result in an increased risk of estrogenic side effects, which includes VTE.
Although the FDA still believes Ortho Evra is a safe and effective medication for women to use for contraception, the bottom line is that those women with concerns or who are at risk for serious blood clots need to discuss all contraceptive options with their health care provider in order to make the best and most informed decision.
Photo courtesy of WTL photos
Labels: birth control, birth control patch, birth control pill, fda, ortho evra, ortho mcneil, the patch, the pill
