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Ortho Evra FDA Black Box Warning
On November 10, 2005, the Food and Drug Administration (FDA) updated the Ortho Evra contraceptive birth control patch labeling to warn women that they are exposed to higher levels of estrogen than from taking birth control pills.
The FDA advised women to talk to their doctor or healthcare provider about whether the birth control patch is the right method of birth control for them and for healthcare providers to warn against the potential risks of increased estrogen exposure.
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The warning further stated: In general, increased estrogen exposure may increase the risk of blood clots. The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximal blood level of estrogen (peak blood levels) is about 25 percent lower with Ortho Evra than with typical birth control pills. While the estrogen level with the patch remains constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly declines to levels that are lower than on the Ortho Evra.
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FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.
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