What the FDA and a major report say about safety of abortion pills

By Kerry Dooley Young

With the U.S. Supreme Court overturning the landmark Roe v. Wade case on June 24, 2022, journalists can expect an increased focus on abortion pills.

With that in mind, here are two tips for reporting on the safety of abortion pills.

1. Explain the potential risks of mifepristone, also known as RU 486, in proper context, as you should for any medicine. This treatment has been subject to an unusual level of scrutiny because of ongoing political fights over abortion.

2. Describe the funding and context of any studies or reports on medication abortion.

I’ll flesh out these tips after providing a bit of background on mifepristone and the state of play on abortion laws in the United States.

What’s happened and what’s next

Last year, The Supreme Court began a review of what’s considered a legal bid to give states the authority to ban abortions.

On May 2, Politico published a leaked draft of a decision on this case, Dobbs v. Jackson Women’s Health. The draft decision would overturn earlier pivotal rulings made in Roe v. Wade and Planned Parenthood v. Casey regarding legal access to abortion. May 3, the Supreme Court released a statement confirming the authenticity of the document but said it might not represent a final position.

State officials have long been preparing for a Supreme Court case that allows for either an outright ban or greater restrictions on abortion access, wrote Kaiser Family Foundation researchers Laurie Sobel, Alina Salganicoff, and Amrutha Ramaswamy in a May 16 report. There’s an expectation that half of states will seek to block legal abortion, they noted.

But there’s also “growing momentum in a handful of states” to protect abortion access for state residents and expand access for residents of states that ban or restrict it, the Kaiser Family Foundation researchers wrote. The expected state bans have spurred more interest in providing medication abortion via telehealth.

“It is not clear, however, if these clinicians would be subject to criminal or civil liability in the states that ban abortion or telehealth abortion should they dispense medication abortion pills to people living in states that either ban telehealth for medication abortion or ban all abortions,” Sobel, Salganicoff and Ramaswamy wrote. “Consequently, states seeking to protect abortion access are looking for ways to protect clinicians residing in their state from other states’ legal liability.”

There has been a trend in recent years toward greater use of abortion pills over procedures. In 2020, medication abortion accounted for 54% of U.S. abortions, marking the first time this approach crossed the threshold to become the majority of all abortions, according to the nonprofit Guttmacher Institute.

In 2000, The Food and Drug Administration (FDA) first approved the use of the drug mifepristone, also known under the brand name Mifeprex, in combination with another medicine, misoprostol, to end early pregnancies. This treatment interrupts the hormone progesterone the body needs to continue a pregnancy.

Tips for reporters

1. Explain the potential risks of abortion pills in the proper context, as you should for any medicine. This medicine has been subject to an unusual level of scrutiny because of continuing political battles over abortion.

Virtually all medicines have the potential to cause harm and/or help people. Even over-the-counter painkillers such as nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen pose some risk. The agency also has taken steps over the years to convey to consumers the potential for serious liver damage connected with the use of the drug acetaminophen.

When writing about any drugs, journalists should educate people about potential complications. These details are often left out or given little emphasis in stories about most medicines. Because of continuing political debates over abortion, mifepristone’s potential for complications has been subject to an unusual level of scrutiny.

Key experts have concluded that Mifepristone can be used safely and serious side effects are rare, according to the FDA and the American College of Obstetricians and Gynecologists (ACOG). That’s also the conclusion reached by an expert committee convened by the National Academies of Sciences, Engineering and Medicine (NASEM) to review abortion practice in the United States.

“The risks of medication abortion are similar in magnitude to the risks of taking commonly prescribed and over-the-counter medications such as antibiotics and NSAIDs,” the committee wrote in its 2018 report, The Safety and Quality of Abortion Care in the United States.

An estimated 4.9 million women in the United States had used mifepristone as a prescription medicine to end a pregnancy between its 2000 FDA approval and June 2021, the agency said in one of its regularly posted reports about this drug. The FDA said that there have been 26 reported fatalities among these women, a tally that the agency said includes cases regardless of whether they have been conclusively tied to the drug. Sepsis was associated with eight reported fatalities. In one case, the cause of death could not be determined. This count includes two cases of ruptured ectopic pregnancy and two cases of homicide. Other causes of death in these cases included: delayed onset toxic shock-like syndrome, hemorrhage, blood clots in the lungs (bilateral pulmonary thromboemboli), unintentional overdose resulting in liver failure, methadone overdose, suspected homicide, suicide and a case of natural death from severe pulmonary emphysema.

In the report, the FDA notes that its tally may differ from reports based on Freedom of Information Act (FOIA) requests. That’s because the FDA has eliminated duplicate reports, and in some cases, reclassified the adverse event terms after reviewing the cases, the agency said.

Again, when covering medicines, journalists should neither overplay nor minimize associated risks. It’s good to, at a minimum, read the prescribing label for any drug on which you are reporting. There will be information on the label about what potential risks that have already been observed.

You can find the labels for prescriptions on the Drugs@FDA website. If you have questions about this, please send an email to patientsafety@healthjournalism.org.

The Mifeprex label notes that serious and sometimes fatal infections and bleeding occur very rarely following spontaneous miscarriages as well as medical and surgical abortions.

KFF has a summary of the FDA’s actions over the years to regulate mifepristone.

2. Describe the context and funding of any studies or reports you quote on medication abortion — or any other concern.

As with the tip above on adverse events, this is something journalists should do when reporting on any study. But it’s even more important when covering abortion, where there are strong political arguments at play.

The 2018 NASEM report mentioned above is also worth a look if you are reporting on the abortion, whether done by medication or a procedure. NASEM is a well-respected nonprofit group. Members of Congress and researchers rely on work done by NASEM committees, considering the organization’s work, in general, to be authoritative.

In a description of its processes for conducting studies, NASEM said it recruits independent experts “with a range of views and perspectives” to review and comment on draft reports prepared by its committees. Groups that sponsor these reports “are not given an opportunity to suggest changes in reports,” NASEM said.

The 2018 abortion report on abortion is the result of a request made to NASEM by six private foundations, which provided funding for this project. Some of these groups have well-known founders who long connected to efforts to provide women with safe access to reproductive medicine including abortion. I’ve listed the six groups below with links to their tax filings, as posted on ProPublica’s NonProfit Explorer website.

Nonprofits file what are called Form 990s with the Internal Revenue Service. Form 990 tells you about the kind of work and organizations a nonprofit supports.

With political debate expected to intensify about abortion pills, be preared to hear lawmakers cite their arguments for and against continued legal access to abortion pills.

In reporting on these comments, it’s important to describe the funding for the study quoted as well as to provide context on where the work was published. Some medical journals may be familiar to your audience and do not need much or any description. If a study cited appears in a lesser-known journal, add details about it.

Publication in a larger, well-known journal does not guarantee a study is free from flaws. But studies that appear in better known journals tend to be more widely read, providing more chances for subscribers to these publications to note any flaws in a study.

Resources

The Government Accountability Office (GAO), which is the investigative arm of Congress, published a 2018 review of the FDA’s handling of an easing of mifepristone restrictions. As part of this review, GAO sought feedback from groups with expertise or deep interest in the topic of mifepristone pills or medication safety.

Below are the groups the GAO selected, and offered as potential sources for stories on mifepristone:

The American Association of Pro-Life Obstetricians and Gynecologists
American College of Pediatricians
American Congress of Obstetricians and Gynecologists (ACOG)
Association of Reproductive Health Professionals
Bixby Center for Global Reproductive Health
University of California San Francisco
Charlotte Lozier Institute
Family Research Council
Guttmacher Institute
Gynuity Health Projects
The lead author of the Mifeprex REMS Study Group
Institute for Safe Medication Practices
National Right to Life Committee
Office of Population
Research, Princeton University
Planned Parenthood Federation of America.

AHCJ also held a session about abortion at Health Journalism 2022 in Austin. “With Roe likely in its final days, experts say reporters should sharpen focus on abortion as a health issue, provides a summary of the discussion and a link the recording. And there’s a data entry on abortion in AHCJ’s Medical Studies section.

Recent articles in the New England Journal of Medicine (NEJM) and JAMA publications on abortion pills include: