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Abortion Pill
Appeals court keeps South Dakota abortion advertising law blocked for now
Bridget Sielicki
·Spotlight Articles
Abortion Pill·By Carole Novielli
Without Guardrails: More abortion pill deaths with fewer adverse events? Not likely.
Since 2016, the number of women's deaths associated with the abortion pill have increased, even as adverse event reports, filed by manufacturers, have dropped — likely due to an Obama administration change requiring only deaths to be reported to abortion pill manufacturers.
Reports given to the Senate HELP Committee indicate that 38 deaths are now associated with the use of mifepristone, the abortion pill.*
The number of adverse events reported prior to 2016 compared to those reported after 2016 are drastically different, though the abortion pill's manufacturers claim they continued to report all adverse events of which they were made aware, though the FDA changed this requirement in 2016 to report only fatalities.
The Committee wrote, "Up until the March 29, 2016 change, Danco had reported about 4,000 non-fatal adverse events associated with the use of Mifeprex. However, since this change, Danco has only reported about 150 non-fatal adverse events over the last 10 years."
A report published by the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee this past summer detailed two additional deaths associated with the abortion pill:
The Food and Drug Administration's (FDA) website (updated in April 8, 2026) only indicates that "As of December 31, 2024, there were 36 reports of deaths in patients associated with mifepristone since the product was approved in September 2000."
Responses sent to the HELP Committee by the drug makers suggested that 38 deaths, not 36, have been associated with the drug.
This comes as the FDA is slated to issue an update regarding its safety review of the drug mifepristone (200mg)/Mifeprex.
The abortion pill was approved in 2000, and prescribers were then required to report all adverse events to Mifeprex manufacturer Danco Laboratories, which was to then report these to the Food and Drug Administration (FDA).
Following multiple women's deaths, the FDA issued warnings and required Danco to issue letters to healthcare providers. The drug was then placed under the FDA's REMS safety system for monitoring.
2002: "We have received... reports of ruptured ectopic pregnancies (including one death from hemorrhage due to a ruptured ectopic pregnancy)... Because ectopic pregnancy may be present despite your best efforts to rule it out before starting Mifeprex treatment, you should be mindful of the possibility of an ectopic pregnancy throughout the treatment period and have a plan for its management."
2004: "Danco Laboratories is providing this information to assist you in taking care of patients who may present in an emergency room setting following treatment with Mifeprex® (mifepristone) and misoprostol. In particular, you should be aware of the rare events – serious infection, prolonged heavy bleeding and ruptured ectopic pregnancy."
2005: "The Food and Drug Administration (FDA) is aware of four cases of septic deaths in the United States."
2006: "The Food and Drug Administration has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex)."
Despite the concerns, pressure was mounting to loosen those requirements.
In 2015, as Live Action News previously uncovered, Danco had little interest in loosening the safety protocols and was also short by millions of dollars to even attempt it.
Some claim Danco 'dragged its feet' because it knew that loosening safety protocols would open the door to generic competitors — which is exactly what happened.
By 2016, Danco had the millions it needed, obtained from unknown sources, and filed a new drug application approved by the Obama FDA. This expanded use of the abortion pill from 7 weeks gestation to 10 weeks and removed requirements that prescribers must report all adverse events, instead requiring only deaths to be reported.
The FDA reports that between 2000 and December 2024, “approximately 7.5 million women” used the abortion pill regimen to end preborn babies’ lives.
In addition, the FDA's current website reports that 36 deaths* of women associated with the drug were also reported. But that number appears to differ from what manufacturers of the drug reported to the Senate HELP Committee.
Correspondence published in an August 2026 report entitled, "Mifepristone Without Guardrails: An Investigation Into How Chemical Abortion Drug Makers Are Putting Mothers and Babies At Risk," indicates the number is now 38.*
A letter to the HELP Committee from Danco noted that the manufacturer of Mifeprex sold "More than six million" drugs since "approval in 2000."
In that same period, "Danco has identified 29 instances in which an individual subsequently died after taking Mifeprex."
GenBioPro, the generic abortion pill manufacturer, provided the HELP Committee "a list of all deaths associated with the use of mifepristone that GBP has reported to FDA since the date of approval in 2019." One of the nine (9) deaths reported by GBP occurred in July of 2025.
GBP also noted that, "Between FDA approval of the ANDA in 2019 and 2023, GBP sold more than 850,000 units of generic mifepristone throughout the United States."
Danco claimed it promptly investigated "all serious and unexpected adverse events, including deaths, consistent with its regulatory obligations," but acknowledged it has "not conducted any postmarketing studies on fatal and/or non-fatal adverse events since Mifeprex’s approval in 2000."
Danco's investigations include:
promptly requesting detailed case information from the reporter, actively following up with health care providers to obtain relevant medical history and outcomes, and submitting the information to FDA and any new information that may become available.
While abortion pill sponsors suggest they investigate all deaths and adverse events, Big Abortion has a long history of covering abortion-related injuries or deaths, lying about the cause of death, failing to call 911, relegating emergency vehicles to back doors, or sending women to emergency departments where they have influence and could receive cover.
In some instances, medical malpractice lawsuits — not the medical examiner or the abortion facility — correctly linked the cause of death to an abortion.
As of the most recent published summary dated December 31, 2024, the FDA reported 4,252 adverse event cases resulting from the abortion pill since 2000.
To the HELP Committee...
Danco reported 4,172 (including deaths) sent to the FDA between 2000 through February 28, 2026 (received by FDA between April 2001 and March 2026).
GenBioPro's reports to FDA indicated 21 (including deaths) received by FDA between June 2019 through May 2026. The last adverse event report by GBP, allegedly occurred in November of 2025, and was listed as "Drug Ineffective."
Nearly 60 were assumed to have been reported by other sources.
Danco Laboratories, GenBioPro (GBP), and generic manufacturer Evita Solutions told the Senate HELP Committee they are required to report all adverse events as well as fatalities to the FDA, despite the 2016 REMS changes removing non-fatal reporting requirements from prescribers.
The HELP Committee looked into adverse event reports before and after the 2016 REMS changes and found a "stark contrast between the number of non-fatal adverse event reports submitted before and after the 2016 REMS change removing the reporting requirement."
The Committee wrote:
Up until the March 29, 2016 change, Danco had reported about 4,000 non-fatal adverse events associated with the use of Mifeprex.
However, since this change, Danco has only reported about 150 non-fatal adverse events over the last 10 years.
GBP’s generic mifepristone product was approved in April 2019, after the 2016 REMS change, but in the seven years since its approval, GBP has only reported about 10 non-fatal adverse events, along with the nine aforementioned deaths it has reported.
... In another illuminating example from these summary reports, there were 97 ectopic pregnancies reported from September 2000 through December 2018. Notably, this number remained at 97 in the December 2024 report, meaning that zero ectopic pregnancies were reported to FDA during that six-year period where FDA reports 3.8 million women took mifepristone.
This is statistically impossible; as Live Action News has documented, even pro-abortion emergency room physicians have warned that women are presenting to ERs with undiagnosed ectopic pregnancies after taking the abortion pill. Their warnings were detailed in 2023 to the New England Journal of Medicine (NEJOM).
Did Danco receive this well-published news for an investigation and report?
Still, by their own admission, prescribers of the drug indicate that the further along a woman is in pregnancy, the less effective the drugs will be, indicating a higher degree of failures.
So we are to believe that fewer adverse events have occurred, even as prescribers of the drug...
... fail to rule out ectopics
... fail to properly date pregnancies
... spend less than five minutes with clients in telehealth appointments, and
... all while prescribing the drug much later than the approved gestational limits?
This simply strains credulity.
The Senate HELP Committee was also suspicious, writing (emphases added):
These findings raise questions about whether the removal of the requirement for certified prescribers to report non-fatal adverse events had a chilling effect on the number of adverse events reported to the drug sponsors.
While the drug sponsors are still required to report non-fatal adverse events they receive to FDA, this requirement does little good if the non-fatal adverse events are not reported to the drug sponsors in the first place.
This concern is magnified when you consider that since the 2023 REMS changes, prescribers can now prescribe mifepristone fully anonymously online, making it next to impossible that non-fatal adverse events would be reported to the drug sponsors.
Even the Fifth Circuit Court of Appeals "characterized the elimination of the adverse event reporting requirement and the subsequent reliance on the absence of non-fatal adverse event reports to demonstrate mifepristone’s safety as a 'deeply troubling' 'ostrich’s-head-in-the sand approach,'" the Committee added.
Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to present to emergency rooms and falsely claim that they are experiencing natural miscarriages.
This deception virtually guarantees that complications have been underreported as well as misreported for many years, and quite possibly will never be accurately reported.
The REMS was placed to assure safety, yet manufacturers of the drug also openly admitted to the Senate HELP Committee that not a single prescriber has ever been decertified, despite public evidence that they are flouting the REMS.
The numbers simply don't add up.
*Not all of these deaths were causally attributed to the drug.
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Bridget Sielicki
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Cassy Cooke
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Bridget Sielicki
·
Abortion Pill
Nancy Flanders
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·
Investigative
Carole Novielli
·
Investigative
Carole Novielli
·
Investigative
Carole Novielli
·Abortion Pill·By Carole Novielli
Without Guardrails: More abortion pill deaths with fewer adverse events? Not likely.
Since 2016, the number of women's deaths associated with the abortion pill have increased, even as adverse event reports, filed by manufacturers, have dropped — likely due to an Obama administration change requiring only deaths to be reported to abortion pill manufacturers.
Reports given to the Senate HELP Committee indicate that 38 deaths are now associated with the use of mifepristone, the abortion pill.*
The number of adverse events reported prior to 2016 compared to those reported after 2016 are drastically different, though the abortion pill's manufacturers claim they continued to report all adverse events of which they were made aware, though the FDA changed this requirement in 2016 to report only fatalities.
The Committee wrote, "Up until the March 29, 2016 change, Danco had reported about 4,000 non-fatal adverse events associated with the use of Mifeprex. However, since this change, Danco has only reported about 150 non-fatal adverse events over the last 10 years."
A report published by the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee this past summer detailed two additional deaths associated with the abortion pill:
The Food and Drug Administration's (FDA) website (updated in April 8, 2026) only indicates that "As of December 31, 2024, there were 36 reports of deaths in patients associated with mifepristone since the product was approved in September 2000."
Responses sent to the HELP Committee by the drug makers suggested that 38 deaths, not 36, have been associated with the drug.
This comes as the FDA is slated to issue an update regarding its safety review of the drug mifepristone (200mg)/Mifeprex.
The abortion pill was approved in 2000, and prescribers were then required to report all adverse events to Mifeprex manufacturer Danco Laboratories, which was to then report these to the Food and Drug Administration (FDA).
Following multiple women's deaths, the FDA issued warnings and required Danco to issue letters to healthcare providers. The drug was then placed under the FDA's REMS safety system for monitoring.
2002: "We have received... reports of ruptured ectopic pregnancies (including one death from hemorrhage due to a ruptured ectopic pregnancy)... Because ectopic pregnancy may be present despite your best efforts to rule it out before starting Mifeprex treatment, you should be mindful of the possibility of an ectopic pregnancy throughout the treatment period and have a plan for its management."
2004: "Danco Laboratories is providing this information to assist you in taking care of patients who may present in an emergency room setting following treatment with Mifeprex® (mifepristone) and misoprostol. In particular, you should be aware of the rare events – serious infection, prolonged heavy bleeding and ruptured ectopic pregnancy."
2005: "The Food and Drug Administration (FDA) is aware of four cases of septic deaths in the United States."
2006: "The Food and Drug Administration has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex)."
Despite the concerns, pressure was mounting to loosen those requirements.
In 2015, as Live Action News previously uncovered, Danco had little interest in loosening the safety protocols and was also short by millions of dollars to even attempt it.
Some claim Danco 'dragged its feet' because it knew that loosening safety protocols would open the door to generic competitors — which is exactly what happened.
By 2016, Danco had the millions it needed, obtained from unknown sources, and filed a new drug application approved by the Obama FDA. This expanded use of the abortion pill from 7 weeks gestation to 10 weeks and removed requirements that prescribers must report all adverse events, instead requiring only deaths to be reported.
The FDA reports that between 2000 and December 2024, “approximately 7.5 million women” used the abortion pill regimen to end preborn babies’ lives.
In addition, the FDA's current website reports that 36 deaths* of women associated with the drug were also reported. But that number appears to differ from what manufacturers of the drug reported to the Senate HELP Committee.
Correspondence published in an August 2026 report entitled, "Mifepristone Without Guardrails: An Investigation Into How Chemical Abortion Drug Makers Are Putting Mothers and Babies At Risk," indicates the number is now 38.*
A letter to the HELP Committee from Danco noted that the manufacturer of Mifeprex sold "More than six million" drugs since "approval in 2000."
In that same period, "Danco has identified 29 instances in which an individual subsequently died after taking Mifeprex."
GenBioPro, the generic abortion pill manufacturer, provided the HELP Committee "a list of all deaths associated with the use of mifepristone that GBP has reported to FDA since the date of approval in 2019." One of the nine (9) deaths reported by GBP occurred in July of 2025.
GBP also noted that, "Between FDA approval of the ANDA in 2019 and 2023, GBP sold more than 850,000 units of generic mifepristone throughout the United States."
Danco claimed it promptly investigated "all serious and unexpected adverse events, including deaths, consistent with its regulatory obligations," but acknowledged it has "not conducted any postmarketing studies on fatal and/or non-fatal adverse events since Mifeprex’s approval in 2000."
Danco's investigations include:
promptly requesting detailed case information from the reporter, actively following up with health care providers to obtain relevant medical history and outcomes, and submitting the information to FDA and any new information that may become available.
While abortion pill sponsors suggest they investigate all deaths and adverse events, Big Abortion has a long history of covering abortion-related injuries or deaths, lying about the cause of death, failing to call 911, relegating emergency vehicles to back doors, or sending women to emergency departments where they have influence and could receive cover.
In some instances, medical malpractice lawsuits — not the medical examiner or the abortion facility — correctly linked the cause of death to an abortion.
As of the most recent published summary dated December 31, 2024, the FDA reported 4,252 adverse event cases resulting from the abortion pill since 2000.
To the HELP Committee...
Danco reported 4,172 (including deaths) sent to the FDA between 2000 through February 28, 2026 (received by FDA between April 2001 and March 2026).
GenBioPro's reports to FDA indicated 21 (including deaths) received by FDA between June 2019 through May 2026. The last adverse event report by GBP, allegedly occurred in November of 2025, and was listed as "Drug Ineffective."
Nearly 60 were assumed to have been reported by other sources.
Danco Laboratories, GenBioPro (GBP), and generic manufacturer Evita Solutions told the Senate HELP Committee they are required to report all adverse events as well as fatalities to the FDA, despite the 2016 REMS changes removing non-fatal reporting requirements from prescribers.
The HELP Committee looked into adverse event reports before and after the 2016 REMS changes and found a "stark contrast between the number of non-fatal adverse event reports submitted before and after the 2016 REMS change removing the reporting requirement."
The Committee wrote:
Up until the March 29, 2016 change, Danco had reported about 4,000 non-fatal adverse events associated with the use of Mifeprex.
However, since this change, Danco has only reported about 150 non-fatal adverse events over the last 10 years.
GBP’s generic mifepristone product was approved in April 2019, after the 2016 REMS change, but in the seven years since its approval, GBP has only reported about 10 non-fatal adverse events, along with the nine aforementioned deaths it has reported.
... In another illuminating example from these summary reports, there were 97 ectopic pregnancies reported from September 2000 through December 2018. Notably, this number remained at 97 in the December 2024 report, meaning that zero ectopic pregnancies were reported to FDA during that six-year period where FDA reports 3.8 million women took mifepristone.
This is statistically impossible; as Live Action News has documented, even pro-abortion emergency room physicians have warned that women are presenting to ERs with undiagnosed ectopic pregnancies after taking the abortion pill. Their warnings were detailed in 2023 to the New England Journal of Medicine (NEJOM).
Did Danco receive this well-published news for an investigation and report?
Still, by their own admission, prescribers of the drug indicate that the further along a woman is in pregnancy, the less effective the drugs will be, indicating a higher degree of failures.
So we are to believe that fewer adverse events have occurred, even as prescribers of the drug...
... fail to rule out ectopics
... fail to properly date pregnancies
... spend less than five minutes with clients in telehealth appointments, and
... all while prescribing the drug much later than the approved gestational limits?
This simply strains credulity.
The Senate HELP Committee was also suspicious, writing (emphases added):
These findings raise questions about whether the removal of the requirement for certified prescribers to report non-fatal adverse events had a chilling effect on the number of adverse events reported to the drug sponsors.
While the drug sponsors are still required to report non-fatal adverse events they receive to FDA, this requirement does little good if the non-fatal adverse events are not reported to the drug sponsors in the first place.
This concern is magnified when you consider that since the 2023 REMS changes, prescribers can now prescribe mifepristone fully anonymously online, making it next to impossible that non-fatal adverse events would be reported to the drug sponsors.
Even the Fifth Circuit Court of Appeals "characterized the elimination of the adverse event reporting requirement and the subsequent reliance on the absence of non-fatal adverse event reports to demonstrate mifepristone’s safety as a 'deeply troubling' 'ostrich’s-head-in-the sand approach,'" the Committee added.
Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to present to emergency rooms and falsely claim that they are experiencing natural miscarriages.
This deception virtually guarantees that complications have been underreported as well as misreported for many years, and quite possibly will never be accurately reported.
The REMS was placed to assure safety, yet manufacturers of the drug also openly admitted to the Senate HELP Committee that not a single prescriber has ever been decertified, despite public evidence that they are flouting the REMS.
The numbers simply don't add up.
*Not all of these deaths were causally attributed to the drug.
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Bridget Sielicki
·Abortion Pill
Carole Novielli
·Abortion Pill
Cassy Cooke
·Abortion Pill
Carole Novielli
·Abortion Pill
Bridget Sielicki
·Abortion Pill
Nancy Flanders
·Abortion Pill
Carole Novielli
·Abortion Pill
Carole Novielli
·Investigative
Carole Novielli
·Investigative
Carole Novielli
·Investigative
Carole Novielli
·The abortion industry has encouraged women to lie about their abortion pill complications when visiting the ER for decades. This deception has misled women—and the rest of the public—about the drug’s actual risks: ➡️ Sepsis ➡️ Infection ➡️ Hemorrhage ➡️ Ectopic pregnancy ➡️ Show more
