Records produced to us in September 2023 also included 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 indicated that during the testing period 32 "Adverse events were reported to Danco and reported by Danco to FDA in periodic reports."
Of the 32 reported adverse events, two were 15-day reports.
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.
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," reported on the "Safety results" for 940 women.
A September 27, 2002, report on mifepristone indicated 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.
In October 2007, we reported on our court victory that forced the FDA to release records about the abortion drug, which included confirmation that the drug was being manufactured in China.
In May 2006, we released a Special Report, containing records that shed light on the Clinton administration's aggressive drive to push RU-486 to market in the United States.
https://www.judicialwatch.org/court-battle-for-cleaner-elections/
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