Fact Sheet: Three Problems with the FDA’s Abortion Drugs Complications Data

Executive Summary

• The FDA’s abortion drugs complications data is woefully incomplete, a problem that parallels issues with incomplete and inconsistent state complications data.
• In recent years, the FDA has continued to roll back safety protections for abortion drugs, making it all the more necessary to gather accurate and complete data on complications.
• In 2016, the FDA stopped requiring the reporting of all complications related to abortion drugs, with the exception of deaths. Other complications can still be voluntarily reported to the FDA Adverse Event Reporting System (FAERS). However, a comparison of FAERS data to state data shows vast discrepancies between complication numbers reported to FAERS and far larger numbers reported to state governments.
• From 2020-2022, the six states that report complications by type of procedure reported 1,004 total complications from drug-induced abortions. Meanwhile, the FAERS data reflects just 17 unduplicated abortion-related adverse events over this same period.

1. The FDA does not collect data on most abortion drug complications.

When the FDA first approved mifepristone in 2000, it put important safety measures in place to regulate the conditions under which the drug could be dispensed, and which medical providers were qualified to do so. These safety measures were later converted to a Risk Evaluation and Mitigation Strategy (REMS). REMS are used to monitor and regulate drugs with a potential for serious adverse effects. Under the original regulations, abortion drug prescribers were required to report all serious adverse events to the manufacturers of mifepristone, who were then required to report them to the FDA.

However, despite research confirming the dangers of abortion drugs, the FDA has steadily rolled back safety protections, expanding the gestational ages at which the drugs can be used, eliminating in-person visits to screen for health conditions , and even allowing the drugs to be sent through the mail. In 2016, the FDA changed complication reporting requirements so that currently abortion drug prescribers are only required to report deaths. All other adverse events – including complications like hemorrhage, sepsis, and hospitalization – are reported on a voluntary basis. This data is stored in the FDA Adverse Event Reporting System (FAERS).

2. Patchwork state complication data gives a glimpse into the issues with the FDA data.

Only a small number of states collect and report data on complications due to abortion drugs. Even among states that do report, quality varies widely, and many states are plagued by underreporting. Further exacerbating this problem of underreporting is the fact that the states with the nation’s largest abortion volumes (California, New Jersey, Maryland, New York, Illinois, and Florida) do not report any abortion complications data. Some of these states don’t even report abortion data at all (CA, NJ, and MD). Eighteen states report either the number of immediate complications from abortion or post-abortive complications. Furthermore, only six states include the type of abortion procedure that caused each complication in their published complication reports.^[1]

Despite the patchwork nature of states’ abortion-complications reporting, the data from the states is useful in that it highlights the vast underreporting of abortion complications to the FAERS. From 2020-2022, the six states reported a total of 1,004 complications from drug-induced abortions.^[2] Meanwhile, the FAERS data reflects just 17 unduplicated abortion-related adverse events that occurred over this time period.^[3] Some of the states allow multiple complications to be reported for a single patient, which could mean that a single incident potentially could be counted multiple times in the state data. However, the fact that a small handful of states counted dramatically more complications than are included in the entire FAERS database indicates that the FDA has been missing the vast majority of complications since rolling back the reporting requirement in 2016.

3. Historically, the FDA has missed a large percentage of all complications.

Even before the FDA weakened the adverse event reporting requirements, data was severely lacking. A study of abortion drug-related adverse events submitted to the FDA demonstrates major underreporting. The analysis compared FDA adverse event data with complications that Planned Parenthood had independently reported in a study on abortion safety. Planned Parenthood reported more than twice as many adverse events as the FDA did from 2009 to 2010, even though Planned Parenthood accounted for less than half of all U.S. abortions during that timeframe.

[1] Four states report the number of immediate complications: Arizona, Michigan, Minnesota, and Pennsylvania. Michigan’s abortion reporting requirements, including the complications reporting requirement, were repealed with the passage of SB 0474 in October 2023. Prior to this repeal, the statute code for the state’s reporting requirements was MCL 333.2835. The 18 states that report post-abortion complications include: Arizona, Arkansas, Idaho, Indiana, Kentucky, Michigan (repealed for 2023 and future data), Minnesota, Missouri, Nebraska (and NRS 28-3107), Ohio, Oklahoma, Oregon (form can be found here), Pennsylvania, South Dakota, Tennessee, Texas, and Wisconsin. Utah voluntarily reports post-abortion complications on resident women in their annual vital statistics reports. Arkansas, Idaho, Indiana, Michigan, Missouri, and Pennsylvania are the six states that have included the type of abortion procedure that caused each complication in their published complication reports. Five of those six states only report complications identified after the abortion procedure, while Michigan reports complications that occurred both during and after the abortion.

[2] The data reported by the states differs from state to state in that some report the number of complication reports while others report the number of individual complications. Another caveat to this data is that Missouri has not reported its 2022 complications data as of March 2024, and Indiana’s reporting law went into effect on October 28, 2021, so the Indiana data for 2021 only represents data from 10/28/21 through 12/31/21. Indiana’s reporting law remains in effect, so the state’s 2022 data represents a full year’s worth of data.

[3] CLI searched the FAERS dashboard for all adverse event reports related to mifepristone or Mifeprex. Adverse events unrelated to abortion were excluded (e.g., those with male patients or for conditions such as cancer or Cushing’s Syndrome). Obvious duplicate records were also excluded from this total. However, many reports are missing critical information, including the event date, age of the patient, and details on the nature of the adverse event. Consequently, some adverse events that were not caused by an abortion may have inadvertently been included in this count, while some abortion-related adverse events may have been accidentally excluded.