Judicial Watch, in collaboration with the Lozier Institute and Susan B. Anthony ProLife, have announced that they have obtained 588 pages of records from the HHS revealing that from 2000 to 2002, at least six deaths were possibly linked to the abortion drug Mifeprex (Mifepristone, formerly known as RU-486).
Seven deaths were detailed in the records released to Judicial Watch, but one of those deaths may have been reported twice.
The records were made public as a result of an October 2022 Judicial Watch Freedom of Information Act (FOIA) lawsuit that was filed after the FDA 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.
The records made public include an “Annual Report for Mifepristone,” covering the period September 28, 2000, to September 27, 2001, produced by the Population Council/Danco Laboratories, LLC.
The summary indicates that during the testing period, 32 “adverse events were reported to Danco and reported by Danco to FDA in periodic reports.” (The existence of adverse event reports does not necessarily establish causation.)
- 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.” [Emphasis added] 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.
According to Judicial Watch:
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. [Emphasis added] 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. [Emphasis added]
In an April 19, 2002, “Dear Health Care Provider” letter from Danco Laboratories, in a section titled “New Safety Information,” 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.
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, 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.
- These revelations come on the heels of an August 16,, 2023, decision by the U.S. Court of Appeals for the Fifth Circuit, in which the Court was asked to consider whether the FDA “overlooked important safety risks in approving mifepristone and amending its restrictions.”
These revelations come on the heels of an August 16,, 2023, decision by the U.S. Court of Appeals for the Fifth Circuit, in which the Court was asked to consider whether the FDA “overlooked important safety risks in approving mifepristone and amending its restrictions.”
The Appeals Court held:
In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.
(The Biden administration is seeking Supreme Court review of the Fifth Circuit’s decision.)
Read lawsuit at this link: Judicial Watch, Inc. v. U.S. Department of Health and Human Services
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