Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Birth Control Health Center

Font Size

Ortho Evra Patch: Clot Risk Updated

Label Adds Details From 2 Conflicting Studies on Nonfatal Blood Clots
WebMD Health News
Reviewed by Louise Chang, MD

Sept. 20, 2006 -- The Ortho Evra patch is getting new labeling with more information on the risk of nonfatal blood clots associated with the patch.

The clotting risk isn't new, and the patch's warning about that risk isn't being strengthened.

The label change simply adds information from two observational studies, publicized by the FDA in February, about clotting risk in women using the patch or birth control pills containing 35 micrograms of estrogen.

The FDA's Daniel Shames, MD, spoke to reporters about Ortho Evra.

Shames is the acting deputy director of the Office of Drug Evaluation III at the FDA's Center for Drug Evaluation and Research.

"We still believe that the risk-benefit profile is appropriate for this particular contraceptive and it's safe and effective when taken with the appropriate label indication," Shames says.

He says the FDA is publicizing the label change to provide information.

"This is consistent with our policy to try to give information as soon as we know it when we think it's reliable information, even at times when we cannot make a specific change in our recommendations," Shames says.

Risk Not New

Ortho Evra, like other hormonal contraceptives, already warned users "not to smoke and not to use the product if they have a history of blood clots, stroke, heart attack, or certain cancers," Shames says.

The patch also already encouraged women "to discuss with their health care professional whether Ortho Evra was the right method of contraception for them," says Shames.

A statement from Ortho Evra's maker, Ortho Women's Health & Urology, encourages Ortho Evra users to consult their doctors with any questions. The company, a branch of Ortho-McNeil Pharmaceutical, also pledges more studies on the topic. Ortho-McNeil is a WebMD sponsor.

Conflicting Results

The two studies included data from two insurance companies and had conflicting results, says Shames.

The data covered 400,000 to 500,000 women aged 15-44 using the patch or birth control pills containing 35 micrograms of estrogen.

The studies were purely observational, meaning that women weren't assigned to use either type of birth control. So they didn't directly test the patch as a clot cause.

Today on WebMD

Here's what to expect.
man opening condom wrapper
Do you know the right way to use them?
birth control pills
Here's what to do next.
doctor and patient
His and her options.
Concerned teenage girl
hospital gown
Birth Control Pills Weight Gain
Ortho Evra Birth Control Patch
contraceptive pills
Young couple looking at each other, serious
woman reading pregnancy test result