12/9/06njm

**Q. Are there any Cochrane Reviews about problems with Ortho Evra or
Nuva Ring?**

#1

RE: Are there Cochrane Reviews of the Ortho Evra labeling change issues?

This particular topic wouldn't actually show up in the Cochrane database
for many years because Cochrane analyzes randomized controlled trials.

While there has been greater publicity of the complications with the
patch, at this writing it is not known whether women using Ortho Evra
are at a greater risk of experiencing these serious adverse events.

What is now known is that the patch provides about 60% more estrogen
than a standard 35 ug pill and that in general, increased estrogen
exposure may increase the risk of blood clots. 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 Updates Labeling for Ortho Evra Contraceptive Patch (see FDA full text below)

<http://www.fda.gov/bbs/topics/news/2005/NEW01262.html>

**FDA: Questions and Answers\
Ortho Evra (norelgestromin/ethinyl estradiol**)

<http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm>

**Ortho Evra product site**

<http://www.orthoevra.com/>

#2

**RE: A Cochrane Review of the Nuva Ring?**

No.

Ditto above about a whether a Cochrane Review exists on this topic.

On the other hand, to date there haven't been any increased reports of
untoward effects for the Nuva Ring. The NuvaRing delivers 15 mcg ethinyl
estradiol and 120 mcg of etonogestrel daily and is worn intravaginally
for three weeks of each four-week cycle.

**UpToDate**

**Ethinyl estradiol and etonogestrel: Drug information**

<http://www.uptodateonline.com/utd/content/topic.do?topicKey=drug_a_k/161047&type=A&selectedTitle=1~6>

**Patient Education: Nuva Ring**

<http://www.mckinley.uiuc.edu/handouts/nuvaring/nuvaring.htm>

**Other resources:**

## 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.

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](http://www.fda.gov/cder/drug/infopage/orthoevra/default.htm)