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More FDA Resources
The Ortho Evra® birth control patch was recently approved by the Food and Drug Administration (FDA) to update it's labeling to warn patients, doctors, and healthcare providers of the higher level of estrogen that women are exposed when using the patch compared to other contraceptive pills.
Ortho Evra® is a weekly birth control patch that releases ethinyl estradiol and norelgestromin through the skin into the blood stream. The FDA advises women to talk to their physician about whether the patch is the correct birth control method for them. In general, increased estrogen exposure may increase the likelihood of blood clots, but it is still not know whether women using Ortho Evra® are at a greater risk of experiencing serious adverse events.
The new bolded warning specifically lists that women who use Ortho Evra® are exposed to approximately 60% more total estrogen in their blood compared to taking a common birth control pill containing 35 micrograms of estrogen. While the estrogen level with the patch seems to stay constant for one week until the patch is removed, the peak blood levels with a daily birth control pill rapidly decrease to levels lower than Ortho Evra®.
Ortho Evra® will be continually monitored and examined by the FDA. Ortho McNeil, the manufacturer, is conducting more studies and trials to compare the risk of developing serious blood clots in women using Ortho Evra® compared to women taking typical birth control pills.
Reference:
"FDA Updates Labeling for Ortho Evra Contraceptive Patch," FDA, November 2005.
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