Re: EVRA
From: art fougner, md (evsono@pipeline.com)
Mon Nov 14 12:55:15 2005
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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