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GENERAL INFORMATION |
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September 2006 FDA Ortho Evra Contraceptive Patch Warning & Information Document Updates |
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| On November 10,
2005 the Food and Drug Administration isued
the warning information below, prompting
Ortho-McNeil Pharmeceutical Inc., the makers
of the Ortho Evra patch to issue new prescribing
information: |
| The Food and Drug Administration approved updated labeling for the Ortho Evra
contraceptive patch to warn healthcare providers
and patients that this product exposes women
to higher levels of estrogen than most birth
control pills. Ortho Evra was the first skin
patch approved for birth control. |
| Ortho Evra is a weekly prescription patch that
releases ethinyl estradiol (an estrogen hormone)
and norelgestromin (a progestin hormone)
through the skin into the blood stream. FDA
advises women to talk to their doctor or
healthcare provider about whether the patch
is the right method of birth control for
them. |
| Furthermore, women taking or considering
using this product should work with their
health care 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. |
| 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. In general, increased estrogen exposure
may increase the risk of blood clots. However,
it is not known whether women using Ortho
Evra are at a greater risk of experiencing
these serious adverse events. |
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| Lieff
Cabraser Heimann & Bernstein,
LLP represents persons injured
in vehicle accidents. Click
here to submit your case. |
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| 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% 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 Orthro Evra. |
| 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. |
| The new labeling information
is available along with additional information
for healthcare providers and consumers online at www.fda.gov/cder/drug/infopage/orthoevra/default.htm. |
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