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More FDA Resources
What is FDA announcing today?
Ortho Evra®, the only skin patch approved for birth control, has revised labeling according to a Food and Drug Administration (FDA) announcement. This change includes a bolded warning about higher exposure to estrogen for women using Ortho Evra® compared to taking a traditional birth control pill. Higher levels of estrogen may put some women at increased risk for getting blood clots. When thinking about prescribing or using Ortho Evra®, healthcare professionals and women need to weigh the increased exposure to estrogen against the chance of pregnancy if a birth control pill is not taken daily.
How does the increase in exposure of estrogen affect me when taking Ortho Evra®?
It is not known if a woman using Ortho Evra® is at higher risk for serious side effects than if she is using a traditional birth control pill. Women should discuss with their doctor whether the Ortho Evra® patch is a good method of contraception for them.
Why is the FDA making this announcement?
Women using the Ortho Evra® patch may be exposed to approximately 60% more estrogen compared to someone taking a typical birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting complications such as stroke and heart attack. It is not known if women using the Ortho Evra® patch have a higher risk of serious side effects than women taking a birth control pill.
Can women decrease the amount of estrogen from the Ortho Evra® by only applying a part of the patch?
No. The Ortho Evra® patch should never be altered as it will cause Ortho Evra® to fail in protecting against pregnancy.
What should a woman do if she wants to change from the Ortho Evra® patch to a birth control pill?
Talk to your doctor. The health care professional will help make this change.
Where can more information on Ortho Evra® be found?
If you have any questions regarding the Ortho Evra® birth control patch, please contact the Center for Drug's Division of Drug Information at: 888-INFO-FDA (888-463-6332), or email the FDA at: druginfo@cder.fda.gov.
Reference:
"Questions and Answers - Ortho Evra (norelgestromin/ethinyl estradiol)," FDA, November 2005.
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