UPDATE 4/14/2023 at 4:45pm EDT: SCOTUS has temporarily restored full access to mifepristone until next week. Read here for more info.
A: Loss of FDA approval for mifepristone will result in decreased access to safe abortion care. It will also prevent patients with certain types of miscarriage from receiving one of the standard treatment options.
TL;DR Mifepristone is one of two medications used for the most common type of early abortion. It is also standard treatment for some types of miscarriage. We have decades of data showing that it is safe and works well. Losing access to this medication is likely to result in worse patient outcomes.
What is Mifepristone used for?
Mifepristone was originally approved for medical abortion up to 49 days (7 weeks) after the last menstrual period and is used in combination with another medication, misoprostol. This regimen is now the most common way to end an early pregnancy. Updated data in 2016 supported revision of the original approval, with mifepristone then being approved for up to 10 weeks. In 2021, in response to the pandemic and based on data showing it is safe, the FDA made mifepristone available by mail.
Since its original approval, mifepristone’s uses have expanded. It is now the standard treatment for some types of miscarriages. Mifepristone is combined with misoprostol, reducing the risk of infection or severe bleeding due to the miscarriage. This also allows patients to be in the privacy of their own homes while managing a miscarriage rather than having a surgical procedure. Mifepristone is also sometimes used as part of the treatment for second-trimester stillbirth.
Additionally, ongoing studies about using mifepristone to manage uterine fibroids have had promising results. The drug can also help manage a rare endocrine disorder called Cushing’s disease. Finding new uses for a medication after FDA approval is common and can result in many benefits for patients.
Is Mifepristone safe?
The recent legal claims against mifepristone implied that there are concerns about its safety. These claims are not supported by the science that led to the initial approval *or* by the decades of evidence since then. Mifepristone combined with misoprostol is 95% effective in completing a medical abortion. The most common side effects from its use are cramping, bleeding, nausea, vomiting, and headache. Rarely, heavy bleeding can occur. The cramping and bleeding are much the same as those experienced with a miscarriage. Serious complications, like heavy bleeding, that require hospitalization or a blood transfusion can occur but are rare and occur in less than 1% of users.
All medications have the potential to cause complications and undesired side effects. In fact, common medications like Tylenol and antibiotics have higher rates of serious complications than mifepristone.
Lastly, when assessing the safety and risk of any treatment, the alternatives must be considered.
A patient taking mifepristone to terminate an early pregnancy is already pregnant. There is no option that is without any risk. While very safe, surgical abortion carries its own set of risks and there are more barriers to accessing surgical care. Pregnancy and childbirth in the United States are 10-20 times more dangerous than abortion.
What does care look like without Mifepristone?
Without mifepristone, misoprostol alone can be used for both early pregnancy termination and management of miscarriage. However, misoprostol has higher failure rates when used alone, and therefore the need for surgical treatment increases. This increases the burden on a system already stretched thin by increasingly restrictive laws. Without access to medication abortion, delays in care lead to a later gestational age at the time of termination, which further complicates care. This problem is worse for those in rural areas and for those without the financial and social support to travel for abortion care. For those dealing with the anguish of losing a pregnancy, the loss of the most effective treatment option can make a devastating situation even worse.
As medications go, mifepristone is very safe for the user. Its approval by the FDA for use up to 10 weeks of pregnancy and the ability to be sent by mail was medically and scientifically sound, based on robust safety and efficacy data. Restricting its use will not only make abortion less accessible but will also make the management of some miscarriages and stillbirths more difficult. Allowing the belief system of a single judge or court to rule over what medications can and cannot be prescribed will both have unintended consequences and also set a dangerous precedent.
Where are we now?
On April 7, 2023, in an unprecedented ruling, a federal judge revoked FDA approval of mifepristone. An appeal to this ruling was filed and on April 12, 2023 the 5th circuit federal appeals court temporarily ruled that mifepristone use can continue for now, but with significant restrictions. They restricted use to the first 7 weeks of pregnancy and the court no longer allows the medication to be mailed. These restrictions are not based in medical science. They further hinder access for the 1 in 3 women and girls who now live in a state where abortion is completely inaccessible. The full appeal of this case will be heard in the coming months, and a lengthy court battle is expected. As always, Those Nerdy Girls will follow along and bring the medical facts and data to cut through all the noise.
References and Resources:
ACOG guidelines and data on medication abortion with Mifepristone
ACOG clinical guidance for early pregnancy loss/miscarriage
Details on most recent appeals court ruling