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. Over the past several years scientists discovered that some forms of birth control have higher risks than others. The Patch was shown to put women at greater risks than birth control pills by exposing women to higher levels of estrogen. How does the Patch work, and why is it more dangerous than other forms of birth control?
Hormones and Birth Control
Hormonal birth control has either an estrogen/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 released into the body. This keeps your ovaries from releasing new eggs during a menstrual cycle—which in turn prevents pregnancy. Hormones from the Patch are absorbed through the skin. People who use the Patch apply one patch a week for three weeks and then have an “off week,” just like if they were on the Pill.
However, research scientists discovered that there are many ways that the Patch is not like the Pill. Birth control pills release about 35 micrograms of estrogen a day, which is considered a safe amount. In high doses estrogen can be dangerous and cause side effects such as blood clots, strokes, and heart attacks. Researchers have shown that the Patch exposes a woman to about 60% more estrogen than the Pill. This much higher amount of estrogen can increase the chances of these dangerous side effects.
FDA Updates for the Birth Control Patch
The first birth control patch, Ortho Evra, went on sale in the U.S. in 2002. In 2005, the Food and Drug Administration (FDA) required that Ortho Evra’s label include a warning about the increased levels of estrogen in women who are on the Patch compared to the Pill. The warning also stated that women on the Patch might be more likely to develop blood clots compared to women on the Pill. The research studies at the time had mixed results and were not conclusive.
The FDA strengthened the warning in 2008 after more research studies were published that concluded that women on the Patch are more likely to develop blood clots compared to women on the Pill. In 2011 the FDA upgraded that warning to a “black-box” warning—the strongest warning that the FDA makes — only when drugs have serious and potentially life-threatening side effects.
Ortho Evra was discontinued in the U.S. after the FDA approved Xulane, a generic hormonal birth control patch, in 2014. Xulane delivers the same high levels of estrogen as the Ortho Evra patch. Like the Ortho Evra patch, Xulane’s label has a boxed warning of potential side effects. These include increased risk of heart disease, heart attack and stroke. Ortho Evra is still available in Canada and Europe.
Agile, another pharmaceutical company, is testing a new hormonal patch called Twirla. This patch works like Ortho Evra and Xulane, but it releases about half the estrogen each day. This should decrease side effects and still prevent pregnancy. In 2017, Twirla submitted data to the FDA in an effort to convince the FDA that its patch is effective as well as safe.
The Patch and Depression
A 2016 study by scientists in Denmark found that women who used hormonal birth control were more likely to be prescribed antidepressants compared to women who were not on birth control. Women who were on the Patch were the most likely to take antidepressants compared to women on all of the different forms of birth control that were studied. Teenagers who were on the Patch were the most likely to be treated for depression. While this study does not prove that the Patch causes depression, that is a logical explanation.
Who Should Not Use a Birth Control Patch?
While the FDA still claims that the Patch is a safe choice for some women, other experts are not so sure. In 2008. Johnson & Johnson paid almost $69 million to settle lawsuits
filed on behalf of women who suffered from blood clots, heart attack, stroke, or death after using the Patch.
For women who are not at a particular risk for blood clots or stroke, the FDA still defends the Patch as a safe birth control method. However, the FDA does not compare the relatively safety of different birth control products with each other, they compare each to pregnancy, which also increases the chances of a healthy woman developing a blood clot, heart attack, stroke, or death. The FDA recommends that all women, especially women who smoke or are at risk for blood clots, talk with their health care provider about 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?
To read more about the dangers of birth control pills containing drospirenone, click here.
To find out more about the symptoms of blood clots, click here.
All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.
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.
3 FDA MedWatch (2015). Ortho Evra Safety Information. Retrieved from:
4 FDA Drug Shortages. (2014). Retrieved from: http://1.usa.gov/12z5XZZ
5 Globe Newswire (2017). Agile Announces Positive Top-Line Phase 3 Results. Retrieved from:
https://globenewswire.com/news-release/2017/01/03/902984/0/en/Agile- Therapeutics-Announces-Positive- Top-line- Phase-3- Results.html
5 Huffington Post (2016) Landmark Study Links Birth Control and Depression. Retrieved from:
http://www.huffingtonpost.com/entry/how-your- birth-control- could-be- affecting-your-mood_us_57eac31ee4b024a52d2b13c4
6 Skovlund, C.W. et. al. (2016). Association of Hormonal Contraception with Depression. JAMA.
Retrieved from: http://jamanetwork.com/journals/jamapsychiatry/article-abstract/2552796