Abortion pill risks 'undercounted,' court document claims

In a motion to intervene in the ongoing lawsuit, State of Missouri v. FDA, challenging the expansion of the abortion pill mifepristone (200mg), the states of Texas and Florida claim that "inadequate adverse event reporting" has led to the undercounting of "true rates of risks associated with chemical abortion drugs," meaning that the risks are "therefore... unknown."

Key Takeaways:

• The motion of Texas and Florida to intervene in an abortion pill lawsuit has pointed out the inadequacies of adverse event reporting regarding mifepristone.

• Some of the points the states make are that the abortion drug harms women and girls — at times resulting in trips to the emergency room, that they harm mental health, and more.

• The states argue that the entire approval process for the abortion pill, as well as the removal of safety requirements of the abortion pill, have been politicized.

The Details: 

In their motion to intervene in the aforementioned lawsuit, the states of Texas and Florida pointed out that, during the Biden-Harris administration, the Department of Health and Human Services (HHS) celebrated the 50th anniversary of Roe v. Wade. At that time, HHS had just overseen the Biden FDA as it relaxed the safety regulations (REMS) on mifepristone:

After the FDA modified the REMS for mifepristone, HHS issued a report called Marking the 50th Anniversary of Roe: Biden-Harris Administration Efforts to Protect Reproductive Health Care. In this report, HHS identified the January 2023 REMS change as one of the actions HHS took to protect access to abortion after Dobbs.

In an accompanying press release, HHS highlighted the FDA’s modification of the REMS for mifepristone as one of the Department’s 'six core priorities' to 'protect and expand access' to abortion post-Dobbs.

The motion also noted that even the Biden White House acknowledged that "the FDA’s 2023 permanent removal of the in-person dispensing protection" was initiated "in response to President Biden’s executive order directing HHS to 'protect and expand access to abortion care, including medication abortion.'"

As noted in our previous article, the FDA removed protections without proper studies about the risks.

Abortion Drugs Harm Women and Girls

The states argued in the motion:

• "Abortion drugs harm women and girls. The FDA’s Patient Agreement warns women that a range of listed 'symptoms' could 'require emergency care.' Mifepristone’s label states that roughly one in 25 women who take abortion drugs will end up in the emergency room. The FDA acknowledges that up to 7% of these women require a 'surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding' and other 'miscellaneous complications.'"

• "... the effects of the abortion pill are sometimes far more devastating than a trip to the emergency room, or even surgical intervention. Since mifepristone’s approval in 2000, 36 mifepristone-related deaths have been reported to the FDA."

Abortion Pills 'Deleterious to Mental Health'

The states also claimed:

• "Chemical abortions are often deleterious to mental health and leave women feeling unprepared, silenced, and filled with regret.... These effects are sometimes experienced immediately, and some women seek to reverse the effects of mifepristone. For others, these feelings develop upon seeing the bodies of their lifeless children."

• "Some abortion providers exacerbate the risk of psychological harm by failing to inform women what they may witness when they use abortion drugs. For example, one woman was surprised and devastated to see that her baby 'had a head, hands, and legs' with '[d]efined fingers and toes.'"

• "It is common for women who see the aborted child to experience shame, regret, anxiety, depression, drug abuse, and suicidal thoughts because of the abortion. Psychological trauma is also caused by the physical toll of the chemical abortion, as many women are 'totally unprepared for the pain and bleeding they experience[] due to chemical abortion.'"

The Background:

'Politicized' approval of abortion pill

The states of Texas and Florida have suggested that the FDA 'politicized' the approval and subsequent expansions of the abortion pill (mifepristone 200mg). One of the many things these states pointed to was a change made on the label and medication guide of the drug, something that Live Action News previously documented.

In their filing, the two states suggested that "The FDA’s regulation of mifepristone was political from the start," reiterating further in the document that "The FDA’s decision to approve mifepristone... was pure politics."

While the drug was approved in 2000 under the Bill Clinton Administration, it was the Obama administration’s FDA in  2016 that weakened the REMS safety requirements by removing the in-person requirement for taking the drug and removing the requirements that the manufacturer report the drug’s non-fatal adverse events (complications).

For decades abortion insiders have suggested that women experiencing an abortion pill complication should lie and claim to be miscarrying naturally when they present to the emergency room. This scheme virtually guaranteed that accurate numbers on abortion pill adverse events or deaths will never be reported as such to authorities.

As Live Action News previously suggested, at that time the FDA seemed to be complicit in the scheme by removing language on the drug's label which instructed abortion pill clients to take the drug's medication guide to the ER with them, further diminishing the chance that ER staff would ever know the woman was in fact experiencing an abortion pill complication.

The text, in the FDA’s 2019 Mifepristone label (as well as older labels), previously stated, “Advise the patient to take the Medication Guide with her if she visits an emergency room or a healthcare provider who did not prescribe MIFEPREX, so that the provider knows that she is undergoing a medical abortion (emphasis added).”

But, the drug's  January 2023 label and later March 2023 label eliminated this specific text (see images below) from the black box warning and the patient counseling section of the abortion pill’s label.

Other Changes

In their request to intervene, the States of Florida and Texas also noted these changes, writing:

• "The 2023 REMS also permanently 'remove[d] the statement that the Medication Guide will be taken to an emergency room or provided to a healthcare provider who did not prescribe mifepristone so that it is known that the patient had a medical abortion with mifepristone.'"

• "FDA formerly conditioned a mifepristone prescription on a patient’s agreement to take the Medication Guide with her if she visits an emergency room or health care facility with complications 'so that they will understand that [the patient is having] a medical abortion[.]' Such disclosure ensures that providers explain to each 'what to do if the patient experiences symptoms that may require emergency care.' It likewise ensures that a third-party physician will effectively diagnose and treat a woman’s abortion-drug complication."

• "Even so, the 2023 REMS jettisons the requirement that a woman 'take the Medication Guide with [her if she] visit[s] an emergency room or [health care provider] who did not give [her] mifepristone so the emergency room or HCP will understand that the patient is having a medical abortion.'"

• "Despite the Guide’s longstanding role in administration of mifepristone, FDA 'concluded'—without citing any literature or evidence—that 'patients seeking emergency medical care are not likely to carry a Medication Guide with them, the Medication Guide is readily available online, and information about medical conditions and previous treatments can be obtained at the point of care.'"

In addition, the states wrote that "FDA did not address the health risks associated with misdiagnosing an abortion-drug complication, or the common practice among abortion-drug providers of encouraging women to tell emergency staff that they are having a miscarriage when they present with complications."

Shrouded in Deception

The court document also noted the intentional and encouraged deception surrounding the abortion pill:

• "Many abortion providers and facilitators shroud their operations in deception and encourage women to lie to emergency room staff by saying they are having a miscarriage if they suffer complications requiring urgent care."

• "For example, one abortionist told The New York Times that she gives her patients who wish to obscure their abortions 'additional plausible deniability’ by, for example, 'send[ing] receipts with a medical code for a urinary tract infection consultation, one of the conditions the service treats, along with written information about U.T.I.s.' If women ask what they should do if they want or need to visit an emergency room, the abortionist 'counsels that there is no medical reason for women to tell hospitals they have taken abortion pills' and that they 'can allow hospitals to assume they are miscarrying[.]'"

• "This advice places women in significant danger, as doctors who mistake botched abortions for a miscarriages may not provide the proper care. Allowing the drug to be self-administered has thus created a state of affairs where emergency room doctors often do not know that their patients are experiencing complications from abortion drugs."

• "The FDA’s decision not to require abortion providers to report all adverse events for chemical abortion drugs harms created an inaccurate and false safety profile for the use of chemical abortion drugs."

The Bottom Line:

"Due to inadequate adverse event reporting, the true rates of risks associated with chemical abortion drugs remain undercounted and therefore are unknown," the document stated.