(Washington, D.C.) – The Food and Drug Administration (FDA) has severely underestimated the rate of adverse events of the abortion drug mifepristone. According to a new analysis, “The Abortion Pill Harms Women,” by the Ethics and Public Policy Center (EPPC), the incidence of serious adverse events is nearly 22 times the rate the FDA currently recognizes on the required drug label for the chemical abortion drug Mifeprex.
Danco Laboratories, the primary manufacturer of Mifeprex has long touted alongside the FDA that its drug is “safe and effective.” But this new real-world analysis concludes that more than one in ten women experience a serious or even life-threatening adverse event within 45 days of taking mifepristone.
The FDA originally approved the drug following data of 30,966 women across 10 clinical trials, some of which were conducted 42 years ago finding an adverse event rate of 0.5%. Contrary to common best practices for all pharmaceutical products, Danco failed to perform after-market research of mifepristone’s complications and has never reexamined its risks since its original approval in September 2000.
According to John Mize, CEO of Americans United for Life (AUL), “It’s clear based upon this analysis that chemical abortive drugs harm women, aren’t highly effective, and the American public has been deceived into believing these drugs are as safe as Tylenol. Nothing could be further from the truth, and we are going to be working with regulators on ensuring that women are protected from these harmful drugs.”
In its analysis, the EPPC used commercially available patient de-identified claims data on mifepristone for 865,727 women to determine an adverse event rate of 10.93%. The vast population of data allows for a far more accurate picture of the adverse effects real women face compared to the original, outdated trial data used for the agency approval.
Now that mifepristone is used for more than 6 in 10 abortions in the United States, the risk this drug poses to women is higher than ever before and existing policies must be reevaluated in light of new data.
AUL echoes the call-to-action EPPC employs in their policy recommendations to the FDA: to reinstate the Risk Evaluation and Mitigations Strategy policies that have steadily and stealthily been removed in recent years. Moving forward, AUL plans to focus increased efforts on ensuring pro-woman policy is not only implemented but enforced when examining the expanding issue of chemical abortion.
