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Questions and Answers
Ortho Evra (norelgestromin/ethinyl estradiol)
1. What is FDA
announcing today?
FDA is
announcing a revision to the label for the drug Ortho Evra, the only
skin patch approved for birth control. This change includes a new
bolded warning about higher exposure to estrogen for women using the
weekly patch compared to taking a daily birth control pill
containing 35 micrograms of estrogen, a commonly prescribed dose.
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 balance the
increased exposure to estrogen against the chance of pregnancy if a
birth control pill is not taken daily.
2. Why
is the FDA making this announcement?
A woman on
Ortho Evra may be exposed to approximately 60% more estrogen than
if she were taking a typical 35 microgram estrogen birth control
pill. There are also high dose estrogen pills on the market, such as
the 50 microgram birth control pills, and some women need these.
Estrogen use is linked to blood clots in the legs and lungs and
other clotting problems such as strokes and heart attacks. It is
not known if women using Ortho Evra have a higher risk of serious
side effects than women taking the typical 35 microgram estrogen
pills.
3. How
does the increase in exposure of estrogen affect me when taking
Ortho Evra?
In general, a
woman may be at higher risk for getting side effects if she takes
higher doses of estrogen. However, it is not known if a woman using
the Ortho Evra patch is at higher risk for serious side effects than
if she is using a typical birth control pill. Women should discuss
with their health care professional whether the Ortho Evra patch is
a good method of contraception for them.
4. Can a
woman decrease the amount of estrogen from the Ortho Evra patch by
cutting the patch and applying only a part of the patch?
No. The patch
should not be cut. If cut or altered, Ortho Evra will not protect
against pregnancy.
5. If a
woman wants to change from the Ortho Evra patch to a birth control
pill, what should she do?
Talk to her
health care professional. The health care professional will
help her make this change.
6. Where
can I find more information on this?
If you have
further questions regarding any medications, please contact the
Center for Drug’s Division of Drug Information at: 888-INFO-FDA
(888-463-6332), or email us at:
druginfo@fda.hhs.gov.
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Date created: November 10, 2005, updated September 20, 2006 |
