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Updated Labeling for Ortho Evra
Recent pharmacokinetic data clarify that women who use the Ortho Evra transdermal contraceptive patch are exposed to higher estrogen levels than women who use oral contraceptives (OCs) or the vaginal ring (Journal Watch Women’s Health Oct 18 2005). The use of estrogen-containing contraceptives, as well as pregnancy, is associated with an elevated risk for venous thromboembolism (VTE). To date, there is no evidence that VTE risk is higher with the patch than with OCs. Nonetheless, citing pharmacokinetic data, the FDA approved updated labeling for Ortho Evra on November 10, 2005, to advise clinicians and patients that estrogen exposure is higher with the patch than with typical OCs containing 35 µg of estrogen. The FDA recommends that women speak with their clinicians about whether the patch is a suitable birth control option for them.
The FDA continues: " . . . Women taking or considering using this product should work with their healthcare providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses."
Comment: Clinicians and their patients should keep in mind that VTE risk is higher with pregnancy and childbirth than with use of estrogen-containing contraceptives. Neither the pharmacokinetic data nor the updated labeling should be cause for panic. Hopefully, epidemiologic data assessing VTE risk with the contraceptive patch will become available in the future. In the meantime, it may be useful to think of Ortho Evra as similar to an OC containing 50 µg of estrogen.
If women view the patch as more appropriate for them than other contraceptives, ongoing use or initiation makes sense. In contrast, if women can confidently use effective alternatives — such as OCs, the vaginal ring, or injectable or intrauterine contraceptives — they should consider these options. Of note, current or potential contraceptive patch users with the following thrombosis risk factors might particularly be counseled to consider alternate birth control methods: hypertension, migraine, obesity, and older reproductive age (40s or early 50s).
— Andrew M. Kaunitz, MD
Published in Journal Watch Women's Health November 22, 2005