New Warnings About the Birth Control Patch

Keris KrennHrubec and Diana Zuckerman, PhD

Originally published July 2008
Up-to-date as of August 2010

When choosing a method of birth control, most women want what is the most effective and convenient. Women who want “hormonal” birth control can choose a pill, patch, injection, or vaginal ring. Using hormones for birth control has various benefits and risks. Scientists are starting to discover that not all of these options have equal risks. The Patch, Ortho Evra, is now shown to put women at greater risks than birth control pills did by exposing women to high levels of estrogen, and because of this some doctors are calling for its withdrawal from the market. How does Ortho Evra work, and why is it more dangerous than other forms of birth control?

Hormones and Birth Control

Hormonal birth control has either an estrogen and progestin combination, or just progestin alone. These are the two hormones naturally produced by a woman’s body that cause her to have her period. When this type of birth control is used, an artificial stream of hormones is pumped into the body. This keeps your ovaries from releasing new eggs during a menstrual cycle, and consequently keeps a woman from getting pregnant.

Ortho Evra

While the Pill goes through your digestive system, hormones from the Patch are absorbed through the skin, much like a nicotine patch. Users of the Patch apply one patch a week for three weeks, and then have an “off week”, just as they would if they were on the Pill.

Research scientists are discovering, however, that there are many ways that Ortho Evra is not like the Pill. Traditional birth control pills release about 35 micrograms of estrogen a day, which is a safe amount. In high doses estrogen can be dangerous, with side effects such as blood clots, strokes, and heart attacks. All hormonal birth control methods have these side effects, so women who smoke or who are at risk for heart disease are warned about using them. New research is showing that Ortho Evra exposes a woman to about 60% more estrogen than the Pill, an amount that can increase these side effects and be extremely dangerous for some women.

FDA Updates Ortho Evra Label

On January 18, 2008, the Food and Drug Administration (FDA) announced that the Ortho Evra label must include a warning about the increased risk of serious blood clots that can result in a pulmonary embolism (sudden blockage of an artery in the lung) and possibly cause death.1 The results of a study sponsored by Johnson & Johnson (the company that makes Ortho Evra), showed that women aged 15 – 44 who were on the Patch were at a much greater risk for developing blood clots than women on the Pill.1

A recent research review showed that women who used the Patch experienced more side effects such as nausea, vomiting, bleeding between periods, and breast discomfort than women who were on the Pill or the Ring.2 Patch users were also more likely to stop using their birth control and switch to a different kind due to these uncomfortable side effects.2

This is the second time that the Ortho Evra label has been changed to include new warnings since it went on sale in 2002. In 2006, the FDA recommended that a warning be added about the increased risk of blood clots when on the Patch, and women have become increasingly concerned about their safety while using the Patch.

Who Should Not Take Ortho Evra?

While the FDA still maintains that the Patch is a safe choice for some women, other people are not so sure. There are currently many lawsuits against Johnson & Johnson on behalf of otherwise healthy women who were harmed or died while using the Patch. The update of the warning label of Ortho Evra was partly due to Canadian reports of two deaths, one heart attack, and 16 patients with blood clots since 2004 among those using Ortho Evra.

For women who are not at risk for blood clots or stroke, the FDA still defends Ortho Evra as a safe birth control method. However, the FDA recommends that all women, especially women who smoke or are at risk for blood clots, carefully consider with their health care provider which method of birth control is best for them. Perhaps the most important question is: why take a risk with the Patch when safer alternatives are available?

References

1 FDA News. (2008, January 18). FDA Approves Update to Label on Birth Control Patch. Retrieved from: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html

2 Lopez, LM. (2003). Skin patch and vaginal ring versus combined oral contraceptives for contraception. The Cochrane Database of Systematic Reviews. 1.