Warning Added to Birth Control Patch

Ortho Evra Patch Exposes Women to More Estrogen Than Birth Control Pills; May Raise Risk of Blood Clots, Says FDA

From the WebMD Archives

Nov. 11, 2005 -- Ortho Evra, the birth control skin patch, will get a new bolded warning stating that the patch provides a higher exposure to estrogen than birth control pills.

"Higher levels of estrogen may put some women at increased risk for getting blood clots," states the FDA.

The FDA provided these questions and answers about the new warning:

What is the FDA announcing?
The 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 with 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, health care 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.

Why is the FDA making this announcement?
A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she was 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.

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.

Continued

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.

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.

Where can I find more information on this?
If you have further questions regarding any medications, please contact the FDA's Center for Drug's Division of Drug Information at (888) INFO-FDA (888) 463-6332, or email the FDA at druginfo@cder.fda.gov.

Maker's Statement

Ortho Evra's maker, Ortho-McNeil Pharmaceutical, issued a news release about the label change.

The news release echoes many of the points covered by the FDA. It also notes that Ortho Evra has been used by more than 5 million women and "remains a safe and effective product, when used according to the product's label. However, hormonal contraception is not suitable for all women. It is important that women speak with their healthcare professionals about what option is right for them."

The company also states that "most side effects of the patch are not serious and those that are occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke, and heart attacks, and are increased if you smoke cigarettes.

"Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the patch are strongly advised not to smoke," the news release states.

WebMD Health News

Sources

SOURCES: FDA: "Questions and Answers: Ortho Evra." FDA: "Approved Label: Ortho Evra." News release, Ortho-McNeil Pharmaceutical. Associated Press.
© 2005 WebMD, Inc. All rights reserved.

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