Re: EVRA
From: THERESA & GREG KUHN (g91kuhn@msn.com)
Tue Nov 15 08:57:28 2005
How do I get off this forum?
Theresa Kuhn
>From: evsono@pipeline.com (art fougner, md)
>Reply-To: ob-gyn-l@obgyn.net
>To: Multiple recipients of list OB-GYN-L <ob-gyn-l@dns.obgyn.net>
>Subject: Re: EVRA
>Date: Mon, 14 Nov 2005 13:56:44 -0600
>
>No such thing as a free lunch.
>
>Art
>
>At Mon, 14 Nov 2005, Jefferson Delfino 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 b
>rth control pills. Ortho Evra was the first skin patch approved for birt
>control.
> >It is a weekly prescription patch that releases ethinyl estradiol (an es
>rogen hormone) and norelgestromin (a progestin hormone) through the skin
>into the blood stream. FDA advises women to talk to their doctor or heal
>hcare provider about whether the patch is the right method of birth cont ol
>for them.
> >Furthermore, women taking or considering using this product should work
>ith their health care providers to balance the potential risks related t
>increased estrogen exposure against the risk of pregnancy if they do no
>follow the daily regimen associated with typical birth control pills. B
>cause Ortho Evra is a patch that is changed once a week, it decreases th
>chance associated with typical birth control pills that a woman might m ss
>one or more daily doses.
> >The addition of this new warning is a result of FDA's and the manufactur
>r's analysis directly comparing the levels for estrogen and progestin ho
>mones in users of Ortho Evra with those in a typical birth control pill. In
>general, increased estrogen exposure may increase the risk of blood c ots.
>However, it is not known whether women using Ortho Evra are at a gr ater
>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%
>ower with Ortho Evra than they are with typical birth control pills.
> >FDA is continuing to monitor safety reports for the Ortho Evra patch. Th
>manufacturer, Ortho McNeil Pharmaceuticals is conducting additional stu ies
>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 c ntain 35
>micrograms of estrogen.
> >The new labeling information is available along with additional informat
>on for healthcare providers and consumers online at:
>http://www.fda.gov/cder/dr g/infopage/orthoevra/default.htm.
> >
> >####
> >What do you think?
> >Jefferson Delfino
>
>--
>art fougner, md
>
>"I knew I was going to take the wrong train, so I left early."
>Lawrence Peter Berra
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