The Rise of a Convenient Contraceptive
First approved by the FDA in 2001 and released to the public in 2002, the Ortho Evra patch was a novel form of hormonal birth control [1.2.1, 1.5.6]. Developed by Janssen Pharmaceuticals, it offered a convenient once-a-week application, a significant advantage over the daily regimen of birth control pills [1.2.1, 1.7.2]. Each patch contained a combination of the hormones ethinyl estradiol (estrogen) and norelgestromin (progestin) that are delivered transdermally (through the skin) to prevent pregnancy [1.2.1]. With an effectiveness rate between 91% and 99%, it quickly became a popular choice for many women [1.2.1]. The patch's mechanism avoids the first-pass liver metabolism that oral contraceptives undergo and provides sustained hormone levels, which can also improve compliance [1.7.2].
Mounting Concerns and FDA Warnings
The convenience of the patch, however, came with a significant caveat. The primary reason for the eventual discontinuation of the brand-name Ortho Evra patch in the United States revolved around safety concerns, specifically an increased risk of venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism [1.2.4, 1.4.2].
Reports began to surface linking the patch to a higher risk of blood clots compared to traditional oral contraceptives [1.4.5]. The core issue was the level of estrogen exposure. In November 2005, the FDA mandated a label change for Ortho Evra to warn users that the patch exposes them to approximately 60% more estrogen than a standard birth control pill containing 35 micrograms of estrogen [1.5.2, 1.5.4]. Elevated estrogen levels are associated with a higher risk of developing blood clots, which can lead to stroke or heart attack [1.4.1].
Over the following years, the FDA continued to update its warnings as more research became available:
- 2006: The label was revised to include study results that found patch users had a higher risk for blood clots [1.4.2].
- 2008: The warning was strengthened after more studies confirmed the increased risk of blood clots compared to women on the pill [1.2.3].
- 2011: The FDA elevated the warning to a "black box" warning, its most serious level, reserved for drugs with potentially life-threatening side effects [1.2.3]. This included information about the potential risk of VTE [1.2.4].
This series of escalating warnings led to a significant decline in the patch's use. National prescriptions for Ortho Evra in the U.S. dropped from five million in 2006 to about 1.3 million by 2010 [1.2.4].
Understanding the Risk
It is important to contextualize the risk. While the relative risk for patch users was higher compared to some pills, the absolute risk of developing a blood clot remained small for most healthy, non-smoking women under 35 [1.4.4, 1.4.5]. For example, one way to frame the absolute risk is that for every 100,000 users, approximately 100 on the patch might develop a clot, compared to 50 on the pill [1.4.3]. The risk is significantly heightened for individuals who smoke, are over 35, have a BMI over 30, or have a history of blood clots, high blood pressure, or certain cancers [1.4.6, 1.8.2].
The Final Discontinuation and Introduction of Generics
The brand name Ortho Evra was officially discontinued in the United States in 2014 [1.3.1, 1.3.6]. The discontinuation was not technically for safety or efficacy reasons according to an FDA announcement, but it directly coincided with the FDA's approval of a generic version called Xulane in the same year [1.3.5, 1.3.1].
Xulane contains the same active ingredients and hormonal dosage as Ortho Evra and, consequently, carries the same black box warning regarding cardiovascular risks and higher estrogen exposure [1.2.3, 1.6.3]. The market effectively shifted from the brand-name product to its generic successor.
Since then, other contraceptive patches have become available in the U.S., offering different formulations:
- Zafemy: Another generic version of Ortho Evra, containing the same hormones [1.3.6].
- Twirla: This patch uses a different progestin (levonorgestrel) and delivers a lower dose of estrogen (30 mcg) compared to Xulane/Zafemy (35 mcg) [1.3.4, 1.8.2].
| Feature | Ortho Evra (Discontinued) | Xulane / Zafemy | Twirla |
|---|---|---|---|
| Status | Discontinued in U.S. [1.3.1] | Available [1.8.2] | Available [1.8.2] |
| Hormones | Ethinyl Estradiol, Norelgestromin [1.2.1] | Ethinyl Estradiol, Norelgestromin [1.3.4] | Ethinyl Estradiol, Levonorgestrel [1.3.4] |
| Estrogen Dose | ~35 mcg/day (exposed ~60% more than pill) [1.5.2] | ~35 mcg/day [1.8.2] | ~30 mcg/day [1.8.2] |
| Type | Brand Name | Generic | Brand Name |
| Key Warning | Black box warning for VTE risk [1.2.3] | Black box warning for VTE risk [1.2.3] | Boxed warning for VTE risk, less effective in women with BMI ≥ 30 [1.8.2] |
Conclusion
The story of the Evra patch's discontinuation is a case study in post-market surveillance and risk communication. While marketed as a convenient and effective contraceptive, studies revealed that its transdermal delivery system led to higher systemic estrogen exposure than many oral contraceptives, increasing the risk of serious cardiovascular events like blood clots [1.4.1]. A series of increasingly dire FDA warnings educated the public and medical community about these risks, leading to a decline in use [1.2.3, 1.2.4]. The final discontinuation of the Ortho Evra brand in the U.S. was not a recall but a market replacement, as its patent expired and a generic version, Xulane, was approved by the FDA in 2014, carrying the same warnings [1.3.1, 1.3.5]. Today, users have several patch options, including lower-dose alternatives, but the legacy of Ortho Evra underscores the critical importance of balancing contraceptive convenience with hormonal safety profiles.
For more information on contraceptive options, you can visit Bedsider, an online birth control support network.
