A significant new study involving more than 865,000 women challenges the FDA’s safety assertions regarding the abortion pill mifepristone. The study revealed a 10.93% incidence of severe adverse events within 45 days of use, potentially altering public perception of the medication and prompting calls for stricter regulations.
The research, conducted on a vast sample of 865,727 women prescribed the abortion pill between 2017 and 2023, found that 10.93% experienced sepsis, infection, hemorrhaging, or other serious complications post-use. This rate marks a substantial increase compared to the 0.5% reported in earlier clinical trials endorsed by the FDA and the manufacturer Danco, which involved nearly 31,000 participants.
The controversial drug at the heart of the study is mifepristone, also known as Mifeprex. The study, released by the Ethics & Public Policy Center and led by Jamie Bryan Hall and Ryan T. Anderson, utilized an insurance claims database and stands as the largest investigation of its kind to date.
The study’s authors criticized Danco Laboratories’ portrayal of Mifeprex as a safe and effective abortion pill, asserting that current mifepristone abortion practices in the U.S. are not as safe and effective as claimed. They are urging the FDA to reconsider its approval of mifepristone and reinstate more stringent patient safety protocols.
The abortion pill regimen typically involves two medications, mifepristone and misoprostol, approved for use in early pregnancy stages. Mifepristone blocks progesterone, causing the uterine lining to break down and terminating the pregnancy, while misoprostol induces contractions to expel the fetus.
The study’s findings are anticipated to influence public policy discussions surrounding the abortion pill, with advocates calling for increased safety measures and a reassessment of its approval. The study has been accompanied by testimonials from women impacted by the abortion pill, underscoring the need for improved patient safety standards.