FDA Releases Q and A and Other Information Regarding New Ortho Evra Warning and Label Revision

In addition to the rather cryptic press release issued by Ortho-McNeil concerning the serious risks associated with its Ortho Evra birth control patch, the FDA has published its own information for consumers wishing to learn more about those potentially fatal side-effects.

A series of “Questions and Answers” and other information can be found on the agency’s web site. For the benefit of our readers, we are reprinting some of that information and the links at which it can be found:

Questions and Answers

Ortho Evra (norelgestromin/ethinyl estradiol)

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

1. What is FDA announcing today?
FDA is announcing a revision to the label for the drug Ortho Evra, the only skin patch approved for birth control. This change includes a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen, a commonly prescribed dose. Higher levels of estrogen may put some women at increased risk for getting blood clots. When thinking about prescribing or using Ortho Evra, healthcare professionals and women need to balance the increased exposure to estrogen against the chance of pregnancy if a birth control pill is not taken daily.
2. Why is the FDA making this announcement?
A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. There are also high dose estrogen pills on the market, such as the 50 microgram birth control pills, and some women need these. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.
3. How does the increase in exposure of estrogen affect me when taking Ortho Evra?
In general, a woman may be at higher risk for getting side effects if she takes higher doses of estrogen. However, it is not known if a woman using the Ortho Evra patch is at higher risk for serious side effects than if she is using a typical birth control pill. Women should discuss with their health care professional whether the Ortho Evra patch is a good method of contraception for them.
4. Can a woman decrease the amount of estrogen from the Ortho Evra patch by cutting the patch and applying only a part of the patch?
No. The patch should not be cut. If cut or altered, Ortho Evra will not protect against pregnancy.
5. If a woman wants to change from the Ortho Evra patch to a birth control pill, what should she do?
Talk to her health care professional. The health care professional will help her make this change.
6. Where can I find more information on this?

If you have further questions regarding any medications, please contact the Center for Drug’s Division of Drug Information at: 888-INFO-FDA (888-463-6332), or email us at: druginfo@cder.fda.gov

FDA Updates Labeling for Ortho Evra Contraceptive Patch

(http://www.fda.gov/bbs/topics/news/2005/NEW01262.html)

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:

www.fda.gov/cder/drug/infopage/orthoevra/default.htm

Newsinferno.com published a lengthy article regarding Ortho Evra and the dangers associated with its use in yesterday’s edition. We recommend that article to anyone wanting to learn about the troubled history of the “Patch” and the evidence offered by its critics to support their demands to have it banned.

This entry was posted in Legal News. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.