In March 2015, the FDA changed the label for one brand of emergency contraception (EC)—ulipristal acetate (UPA), sold as ella. The new label warned against starting a hormonal birth control method within 5 days of taking UPA. Why the change, and what does this mean for your practice?
The concern behind the ella label change
Since UPA is an anti-progestin, the concern is that using birth control containing a progestin right after taking it may make the UPA less effective. The study that prompted the label change showed that women who used UPA, then started a progestin-only pill (POP) the next day had higher rates of ovulation compared to women who used UPA then started a placebo pill (45% of cycles vs. just 3%). This is compelling evidence that starting this particular type of POP—one containing desogestrel—reduces UPA’s effectiveness. It’s such a big reduction in effectiveness that women may face the same risk of pregnancy as if they had used no EC at all. But there are important limits to what we can learn from this study:
- Desogestrel POPs work differently from other types of POPs.
- Although widely used in Europe, desogestrel POPs are not available in the United States. We have only POPs containing norethindrone, and we don’t know if these pills would have the same impact on UPA.
- We also don’t know if other forms of progestin-only birth control, like the implant, the shot, and hormonal IUDs would have the same impact on UPA.
What does this mean for my patients?
Guidelines used to recommend that patients start birth control immediately after any kind of EC. But in 2016, the CDC recommended that women begin hormonal birth control no sooner than 5 days after taking UPA. They don’t rule out starting the implant, the shot, or a hormonal IUD on the same day as UPA, but they say we should weigh the possible risk of decreased UPA effectiveness against the future risk of pregnancy for women who don’t start these birth control methods. This still leaves a lot of gray area for providers and patients!
At the American Society for Emergency Contraception we’ve tried to take into account factors that impact an individual’s risk of pregnancy in order to offer a more nuanced approach. When you’re counseling EC patients who want to start using hormonal birth control, here are some points to consider:
- Is a non-hormonal IUD an option? Although it’s not for everyone, we can remind patients that the copper IUD is the most effective EC and offers ongoing protection.
- Is UPA even available? Although UPA has been available in the U.S. since 2010, it is not always on hand or in stock at local pharmacies.
- What is this patient’s risk of pregnancy? Only people who had sex close to the time of ovulation are at high risk of a pregnancy. Consider whether your patient’s risk is greater from the act of intercourse that already occurred, or from future sex acts.
- Could this patient return for a follow-up visit? The complex circumstances of your patient’s life may mean that it’s difficult, or impossible, for them to return 5 days later.
- Does your patient need EC because they were late with a pill, patch, or ring? This is a common reason for needing EC. Patients in this situation should be advised to use LNG, rather than UPA, for EC. (And if your patient is having difficulty using their method consistently, you may also want to discuss lower-maintenance birth control options for the future.)
If you rule out a non-hormonal IUD and talk through these other issues, you will likely find that one of these approaches is a good fit:
1) UPA plus ongoing contraception. Provide UPA EC and work with your patient to choose a birth control method to use going forward. Set an appointment for your patient to start the implant, the shot, or an IUD 5 days after the last act of unprotected sex. Or if your patient selected the pill, the patch, or the ring, dispense the new method and set up a reminder to start taking it 5 days after the last act of unprotected sex. Advise your patient to use a back-up method for the next 7 days.
This is a first-choice option when: UPA is available, and the patient is at high risk for pregnancy from the act of intercourse that already occurred and likely to return for a follow-up visit if needed.
2) Levonorgestrel EC plus immediate start of ongoing contraception. Provide LNG EC and immediately begin the patient’s selected contraceptive method. Advise your patient to use a back-up method for the next 7 days.
This is a first-choice option when: UPA is not available, and the patient is at relatively low risk for pregnancy from the act of intercourse that already occurred and is not likely to return for a follow-up visit, and/or is seeking EC because of missed or delayed pills, patch, or ring.
The bottom line
There is still much that we don’t know about how hormonal birth control impacts EC effectiveness. We hope that new studies will clarify how other types of birth control interact with UPA. For now, providers and patients must make the best decisions with the information we have. We hope the approaches described here will help you to balance the risk of pregnancy and the scientific uncertainties.