Ethics and Public Policy Center analyzes abortion pill’s adverse events

The Ethics and Public Policy Center (EPPC) posted a study arguing the serious adverse events for women who take abortion pills are 22x higher than what the FDA claims. Some notes:

EPPC’s Figure 1 (pictured) lists situations they defined as Serious Adverse Events (SAEs). Note some women experienced multiple events, which is why the overall number (10.93%) isn’t just the sum of the individual numbers. In their report they state “We followed the official FDA definition of ‘serious adverse event.'”

Nevertheless there’s going to be debate over which events qualify as SAEs. In particular, there’s pushback about (a) ER visits, (b) follow up D&Cs, and (c) other life-threatening events.

ER visits

ER visits aren’t the same as receiving treatment in the ER which isn’t the same as being admitted to the hospital. Some people may go to the ER because they’re afraid, even if nothing is medically wrong (especially since many women report being surprised by how painful abortion pills are). Many people who visit the ER (whether for abortion pills or anything else) are discharged with no real medical interventions.

Follow up D&Cs

Follow up D&Cs may or may not indicate an SAE. Even abortion activists acknowledge some percent of women taking abortion pills will have to go in for surgical follow up if the pills don’t complete the abortion. A follow up D&C could be an emergency or it could be a routine procedure when they realized the pills didn’t work. (Then again a lot of people who argue that telemed abortion is fine don’t think follow up appointments to verify complete abortion should be required, so there’s that.)

Other events

It’s not clear what the EPPC means by “other life-threatening adverse events.” Elsewhere in the report they state “Other abortion complications include codes specifically related to an abortion or miscarriage, as well as life-threatening mental health diagnoses, etc.” I’m not sure if this line is meant to refer to the “other life-threatening adverse events” specifically, but either way it doesn’t tell us much.

Still, even if you exclude entirely ER visits, repeated surgical abortions, and the “other” section from the analysis, the data makes abortion pills look riskier than are currently advertised. FDA claims less than 0.5% SAEs for abortion pill users. EPPC’s data found that just infection was 2.6x that rate. Hemorrhage was 6.6x.

Notably ectopic pregnancy alone was 0.35%, already approaching FDA’s 0.5% claim for all serious adverse events. Abortion pills do not work for ectopic pregnancy, and in fact can be dangerous as they can mask symptoms that might cause women to seek medical care for ectopic pregnancy. Still the FDA doesn’t require abortion providers to confirm intrauterine pregnancy before giving abortion pills.

Worth noting too, that EPPC measured SAEs only up to 45 days after abortion, which is more conservative than the studies the FDA relied on that went up to 72 days.

The EPPC’s report is not published in a journal, so they aren’t required to publicize specific methods or results etc. This can make it difficult to parse some details. (We were just talking about this issue with the pro-choice org Gender Equity Policy Institute’s recent maternal mortality report.) EPPC’s publicly released data so far doesn’t make clear which patients had more than one SAE and how those stats break down. We don’t yet know the demographics of the study population. We don’t know exactly how they’ve defined “other complications.” I’m not clear why they included in their analysis prescriptions for mifepristone-only without misoprostol.

Hopefully that info is forthcoming. But in the mean time, at minimum the FDA 0.5% SAE rate sounds pretty iffy. I’m glad someone is trying to look at updated data about abortion pill events as the percent of abortions done by pill instead of procedure continues to skyrocket.