The U.S. Food and Drug Administration (FDA) has reported that mifepristone, a drug commonly used in medication abortions, has been associated with over 4,000 serious adverse side effects and 151 deaths. This information comes from the FDA's adverse event database, as detailed by Restoration News.
According to Reuters, mifepristone is the primary drug prescribed for medication abortions in the United States and has been used millions of times since its approval by the FDA in 2000. The FDA monitors drug safety through the Adverse Event Reporting System (FAERS), which depends on voluntary reports from healthcare providers and manufacturers. However, Reuters notes that experts widely acknowledge these voluntary systems suffer from significant underreporting, complicating efforts to fully assess the drug’s risks and adverse outcomes.
Restoration News reviewed the FAERS database and found that as of June 2024, there were 7,671 adverse event reports linked to mifepristone. Of these reports, more than 4,000 were categorized as serious, with 151 deaths reported. This figure is significantly higher than the 36 deaths currently acknowledged by the FDA on its website specifically for abortion use. Restoration News indicates that serious cases include life-threatening complications such as sepsis, hemorrhage, uterine rupture, and ectopic pregnancy. This suggests a potential gap in public health surveillance.
The Charlotte Lozier Institute conducted an analysis in 2021 revealing that from 2020 to 2022, six U.S. states reported a combined total of 1,004 chemical abortion complications. In contrast, only 17 such cases appeared in the FAERS database during the same period. The study concluded that federal adverse event reporting for chemical abortion is highly incomplete due to inconsistent and voluntary reporting requirements. The Institute argues this discrepancy highlights a systemic gap in the FDA’s current approach to tracking and disclosing drug safety information.
RestoretheMilitary.com explains that Restoration News serves as its investigative and reporting arm focused on reviewing federal databases to uncover potential lapses in drug safety oversight and military health policy. The platform regularly analyzes government reports and third-party studies to identify areas where official data may be incomplete or misleading. Restoration News describes its mission as advancing accountability, public health, and transparency within federal and military regulatory systems.