Frequently Asked Questions about Ortho Evra, the Contraceptive Patch

What is Ortho Evra, the birth control patch?

Ortho Evra, more commonly known as “the patch” is a form of birth control that releases

    hormones transdermally, or through the skin. It is a thin patch that adheres to the body and is worn for three weeks, and left off for the forth week, simulating the standard menstrual cycle. The patch was approved by the FDA in 2002. Because it is only changed once a week, it is considered to be much easier to use consistently than the birth control pill and therefore more effective than the birth control pill. The patch does not protect against sexually transmitted infections or HIV/AIDS.

How does the patch work?

    The patch works like other methods of hormonal contraception, by slowly releasing estrogen and progestin hormones—the same hormones found in birth control pills—directly through the skin.

    These hormones cause a woman’s ovaries to stop their monthly cycle and egg development.

What are the side effects of the patch?

    As with most methods of hormonal birth control, some women experience side effects with the patch. These side effects include bleeding between periods, weight gain or loss, breast tenderness, nausea, and changes in mood. The patch, as with other methods of combined hormonal birth control, is also associated with a small risk of blood clots.

    I heard the FDA recently changed the labeling on Ortho Evra. What are the changes I should know about?

    The FDA has changed the labeling on Ortho Evra to warn patients and healthcare providers that the birth control patch exposes women to 60% more estrogen than the typical birth control

    pill. This means that a woman will have more estrogen in her system than if she used the pill. In general, increased estrogen exposure may increase the risk of blood clots. You can find the new labeling and additional information at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm

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How common are blood clots?

While blood clots can be potentially fatal, they are very rare, occurring in 12 of 10,000 patch 1users and occurring fatally in only 3 out of 200,000 patch users during clinical trials. Two

    manufacturer-funded studies have just been concluded on the comparative risks for blood clots between the patch and the birth control pill. The first study, conducted by i3 Drug Safety found that women using the patch did not have a higher combined risk for heart attack or stroke than women taking the pill, but women using the patch were twice as likely to develop blood clots.

    The second study, conducted by the Boston Collaborative Drug Surveillance Program also found that women using the patch were not at higher risk for heart attack or stroke.

Who is at the highest risk for serious side effects?

    Ortho McNeil has reiterated the warning about serious risks that may occur in women over 35 who smoke and use the patch and the recommendation that women with a history of blood clots, stroke, heart attack, or certain cancers avoid using the patch. Ortho-McNeil’s response can be 2viewed here.

Is the FDA taking further action?

    The FDA announced in early March that it will be conducting a comprehensive examination of all medical patches including patches for pain relief and birth control. The initial focus will be on the effects of heat, such as a hot tub, high fever, or heating pad, on absorption rates of drugs delivered using a patch system. Details of possible future studies have not yet been made 3public.

    What is the most important thing I should know about the birth control patch?

Like every birth control method, the patch isn’t right for every woman. Patients should speak

    frankly and honestly with their physicians about their concerns and medical history. Don’t be

    afraid to ask your doctor questions and tell her what you want. Health care providers should

    similarly be open with their patients about the fact that the jury is still out on the relative safety of the patch.

     1 Food and Drug Administration. Medical Officer’s Review of Ortho Evra. 6 November, 2001. Page 42. http://www.fda.gov/cder/foi/nda/2001/021-180_Ortho%20EVRA_medr_P2.pdf, Accessed 5 August, 2005. 2 http://www.orthoevra.com/about/manufacturing_statement.html 3 http://www.philly.com/mld/philly/living/health/14018264.htm

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