Q&A: What happens if mifepristone loses FDA approval?

Key takeaways:

• On March 26, the Supreme Court will consider mifepristone safety and access for medication abortion.
• Mifepristone is currently FDA approved and considered the gold standard for medication abortion in the U.S.

Since the Dobbs decision in June 2022, mifepristone has been heavily discussed within legal landscapes regarding its safety, efficacy and availability for women seeking medication abortion.

As Healio previously reported, in August, the 5th Circuit Court of Appeals ruled on restrictions to mifepristone (Danco Laboratories) that will require women to have a prescription for mifepristone from a physician and three in-person follow-up appointments. This ruling will not go into effect unless it is upheld by the U.S. Supreme Court. Currently, mifepristone is used up to 10 weeks’ gestation and is available through telehealth-prescribing and mail-order distribution.

“I think mifepristone is incredibly important for women’s health care,” Kristyn M. Brandi, MD, MPH, FACOG, an OB/GYN physician and complex family planning subspecialist, told Healio. “Reproductive health care has few medications that we use regularly, and mifepristone is probably one of the medications I give patients the most often in my practice.”

Today, the Supreme Court will hear oral arguments in the Alliance for Hippocratic Medicine v. Food and Drug Administration and Danco Laboratories v. Alliance for Hippocratic Medicine cases regarding the safety and access of mifepristone for medication abortion in the U.S. This is the first time since the Dobbs decision that the Supreme Court will hear arguments on abortion.

Healio spoke with Brandi about the safety and efficacy of mifepristone, other medication abortion options and the implications of further restrictions on mifepristone use.

Healio: What has been your experience with the safety, efficacy and ease of use of mifepristone?

Brandi: Mifepristone is an incredibly safe medication. It has few side effects and few people are allergic to it. I’ve never seen a patient that’s had an allergic reaction to mifepristone. And, luckily, it’s incredibly safe. It’s something that works incredibly well, and the vast majority of patients who need it report few or no side effects other than what’s expected to happen when they use the medication.

Healio: What are the consequences if mifepristone becomes unavailable?

Brandi: I’m worried if mifepristone becomes unavailable because it’s one of the medications that I use the most frequently with my patients. It is the gold standard that we use for medication abortion as well as other types of uses within reproductive health care and outside of gynecology. It is unfortunate to think about the consequences if we lose this medication, and the broader impact of what it means if a judge can take away a medication from the FDA approval process.

Healio: As mifepristone is caught in legal turmoil, is misoprostol effective alone for medical abortion?

Brandi: Currently, the standard of care is to use mifepristone with misoprostol. There are some regimens that use misoprostol alone, and they’ve been shown to be as effective as using mifepristone and misoprostol together, but you have to use a lot more misoprostol in order for it to be as efficacious as the combination regimen. Because of that, people may have more side effects from misoprostol-only regimens.

For misoprostol, the most common side effects are things like nausea, vomiting, diarrhea and fever. It makes the experience more uncomfortable for many people. The more doses we give, the more uncomfortable it may be, and that’s something I don’t want my patients to have to go through if they don’t need it. It’s great that, currently, we’re able to use mifepristone with misoprostol to lessen those side effects.

Healio: Is mifepristone currently used for any other condition or purpose?

Brandi: Mifepristone is mostly used for medication abortion, but it does have other uses in medicine. It is used for the endocrine disorder called Cushing’s syndrome, but we also use it off-label for several different things around reproductive health. For example, mifepristone has been shown to help people undergoing miscarriage management; it makes the miscarriage process faster than other types of regimens. It is becoming more and more the standard of care to use mifepristone for miscarriage care.

We also use it off-label for a couple of other things, for example, in cervical preparation when we’re going to be doing a procedure where we need to open and dilate the cervix in order to enter the uterus, either if we’re using a camera or we’re doing a procedure in the uterus. Currently, there are some studies looking at mifepristone as an induction agent, meaning that we can use it for induction of labor to help people labor faster. There are a lot of uses both currently and looking in the future for mifepristone use, so it’s concerning what happens if we are unable to use that medication in the future.

Healio: How might the Supreme Court rulings affect mifepristone prescribing for other conditions?

Brandi: It’s hard to say. We don’t know exactly what the Supreme Court will say about mifepristone — whether it will be dialed back and have to go back to older, more outdated regimens for its use, or if it’ll lose its FDA approval altogether. It’s unclear if that is just for medication abortion, or if it means that mifepristone will be off the market and we can’t use it for any of the reasons that we use it in medicine. That’s concerning, because a lot of patients who benefit from and rely on these medications for their health may be impacted.

Healio: Are there any other drugs being studied to replace mifepristone if its approval is taken away?

Brandi: That’s the big concern right now. If we lose mifepristone, at least for the reproductive indications, misoprostol will probably be our go-to, which is currently being used across the globe; it’s the WHO-approved regimen for medication abortion if you don’t have mifepristone. There are currently some trials that are looking at different medications that work similarly to mifepristone. The problem is, it’s kind of silly to have to try to create another drug, another type of intervention, that we can use, when we already know that mifepristone works well.

Losing this medication not only will have an impact for the patients who need this medicine right now, but it will have to put the science community on overdrive trying to figure out how we’re going to be able to replace medications or find new regimens when we already have a medicine that works well.

It’s concerning to think about what this ruling is going to look like, not only for the medicine that we can provide today, but for the medicine we can provide in the future.

Healio: Is there anything else you’d like to add?

Brandi: There’s a new study that came out recently that showed that medication abortion is now 63% of all abortion care, and that rate has been going up since the Dobbs decision. We expect that is because medication abortion is more easily accessible for people who may be in areas where there are abortion bans. People may be getting this medication via telemedicine and that has increased its use. Now, more than half of all abortion care will be impacted if we lose mifepristone access.

We know that people who are using medication abortion and are impacted by bans are more likely to be from marginalized communities. When I think about who will be impacted by the [Supreme Court] ruling, it’s patients seeking abortion, it’s people that need this medication for miscarriage or endocrine disorders, but particularly it’s marginalized folks that otherwise can’t travel to get access to their needed abortion care. It’s concerning to think about what will happen with this ruling, and we’re all waiting to hear what the ruling will show.

Reference:

• Monthly Abortion Provision Study. www.guttmacher.org/monthly-abortion-provision-study#:~:text=How%20do%20I%20cite%20this,osf.io%2Fk4x7t%2F. Published March 19, 2024. Accessed March 22, 2024.

For more information:

Kristyn Brandi, MD, MPH, FACOG, can be reached at @DrKBrandi on X (Twitter).