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Richard Chudacoff, MD
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From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net] On Behalf Of Ana OcaXa
Sent: Monday, November 14, 2005 1:38 PM
To: Multiple recipients of list OB-GYN-L
Subject: Re: EVRA
Maybe this is why breast pain is more frequent with these patches than
contraceptive pills?
Ana Ma. Ocana MD
Mexico
Jefferson Delfino <dr.jefferson@uol.com.br> wrote:
FDA News
FOR IMMEDIATE RELEASE
P05-90
Nov. 10, 2005
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Updates Labeling for Ortho Evra Contraceptive Patch
The Food and Drug Administration today 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.
It 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.
The new bolded warning specifically states that women who use Ortho Evra are
exposed to about 60 percent more estrogen than if they were taking a typical
birth control pill containing 35 micrograms of estrogen. However, the
maximum amount of estrogen to which women are exposed is about 25% lower
with Ortho Evra than they are with typical birth control pills.
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:
http://www.fda.gov/cder/drug/infopage/orthoevra/default.htm.
####
What do you think?
Jefferson Delfino
_____
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