A lawsuit filed by a nonprofit watchdog reveals six women died after taking Mifeprex, the at-home abortion drug also known as Mifepristone or RU-486.
The drug is at the center of several federal lawsuits challenging its 2000 approval by the Food and Drug Administration, with the Biden administration vigorously challenging to keep the abortion chemical legal.
Judicial Watch, working with the Lozier Institute and Susan B. Anthony ProLife, “received 588 pages of records from the U.S. Department of Health and Human Services, revealing that during the two-year period 2000 to 2002 at least six women's deaths were possibly linked to the abortion drug Mifeprex (Mifepristone, formerly known as RU-486),” Judicial Watch reports.
“It is outrageous that Judicial Watch has had to sue in federal court for basic safety information about the abortion pill,” said Judicial Watch President Tom Fitton. “The revelations in the records released today explain why the Biden administration is so desperate to bury this damning information – this drug is potentially dangerous to the mothers as well as the intended victims, the unborn babies.”
The records found multiple incidences of hemorrhaging and bacterial infections after using the abortion chemical, several fatal and one case of a fatal heart attack after using the drug.
Judicial Watch noted the documents recorded seven deaths, but one of the deaths appears to have been reported twice.
“The records were forced out thanks to an October 2022 Judicial Watch Freedom of Information Act (FOIA) lawsuit that was filed after the Food and Drug Administration (a component of HHS) failed to respond to three February 2022 requests for records, including correspondence with the manufacturers of Mifeprex regarding the drug's stability and for all FDA reports from assessments of DANCO and GenBio manufacturing facilities; investigational and new drug applications, as well as stability test results,” Judicial Watch reports.
An “Annual Report for Mifepristone” produced by the Population Council/Danco Laboratories, LLC, found that during the period September 28, 2000, to September 27, 2001 there were 32 “adverse events were reported to Danco and reported by Danco to FDA in periodic reports.”
The report found:
Of the 32 reported adverse events, two were 15-day reports (the others were not serious and/or not unexpected). One of the 15-day reports was reported as “hemorrhage due to a ruptured ectopic pregnancy and death.” The other was reported as “post abortal parametritis/endometritis, adult respiratory distress syndrome and bilateral pneumonia.” This latter 15-day report and one case where fever was reported represent the total reports on the marketed drug suggesting infection. In addition, one infection was reported in the Population Council's 200 mifepristone study and one death [Emphasis added] due to clostridium sordelli infection was reported in the Canadian study.
Judicial Watch found even more deaths and complications, reporting:
A post-marketing study dated September 28, 2001, titled “Comparison of abortions induced by mifepristone followed by vaginal versus oral misoprostol up to 56 days gestation,” reports on the “safety results” for 940 women. One person required a blood transfusion, two required administration of intravenous fluids, one required hospitalization, and one died. The study reports an overall “success” rate of 97.8 percent.
A September 27, 2002, report on mifepristone indicates that in a study of 971 women administered a combination of mifepristone and misoprostol to induce abortions, one subject needed a blood transfusion, two were administered IV fluids, one was hospitalized, and one died.
Judicial Watch also found an April 19, 2002, “Dear Health Care Provider” letter from Danco Laboratories, in a section titled “New Safety Information,” in which the company notes:
We have received a small number of reports of ruptured ectopic pregnancies (including one death [Emphasis added] from hemorrhage due to a ruptured ectopic pregnancy). As you will recall, Mifeprex* and misoprostol are not an effective treatment of ectopic pregnancy. Confirmed or suspected ectopic pregnancy is a contraindication for the use of Mifeprex and should be ruled out prior to initiating Mifeprex treatment. 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.
***
Two cases of serious systemic bacterial infection (one fatal) [Emphasis added] following treatment with Mifeprex and misoprostol have been reported.
***
We have also received a report of a myocardial infarction [heart attack] occurring in a 21-year-old woman three days following use of Mifeprex and misoprostol.
According to Judicial Watch the documents also included a “periodic safety update for mifepristone under the brand name Mifegyne that was conducted by Exelgyn Laboratory for the period June 1, 2001, to May 31, 2002,” which reports:
[T]he Medical Department of Exelgyn recorded from health professionals and authorities 23 spontaneous reports (of which 12 cases of serious adverse events, 11 non serious events and no case from clinical trials) in association with Mifepristone.” [Emphases in original]
The 12 cases of serious events reported during the period of review are classified as follows:
3 serious unlabeled. In which 1 case of unintended pregnancy with fetal malformation, 1 case of death [Emphasis added] and 1 case of thoracic pain (ischaemic accident).
9 serious labeled with 5 cases of unintended pregnancy, 2 cases of allergic reaction, 1 excessive bleeding and 1 septicaemia to Streptococcus.
The opinions expressed in this article are those of the author and do not necessarily reflect the positions of American Liberty News.
READ NEXT: US Military Might Pouring In To Support Israel And Warn Iran
