New Study Raises Alarming Questions About The Safety Of The Abortion Pill: ‘Severe Adverse Effects’

A new study based on insurance data suggests that serious complications from the abortion pill mifepristone are far more common than the FDA label indicates, raising concerns about safety oversight and informed consent.

Key Facts:

  • A study from the Ethics & Public Policy Center found serious adverse events occur in nearly 11% of chemical abortions involving mifepristone.
  • The study analyzed over 865,000 medication abortions between 2017 and 2023, making it the largest dataset of its kind.
  • Current FDA-approved labeling is based on much smaller clinical trials, some conducted over 40 years ago, showing under 0.5% severe complications.
  • Critics argue that the loosening of FDA safety requirements under Obama and Biden has contributed to these risks.
  • Experts on both sides of the issue agree the study has limitations, particularly its reliance on insurance claim data rather than clinical trials.

The Rest of The Story:

The Ethics & Public Policy Center’s study found that the abortion pill mifepristone may cause serious health complications at a rate 22 times higher than what the FDA currently acknowledges.

Using data from over 865,000 insurance claims, researchers concluded that about one in ten women suffered a serious adverse event, including hemorrhage or infection.

FDA approval for mifepristone was based on clinical trials involving only about 31,000 women, many decades ago.

Meanwhile, critics of the study point out it has not been peer-reviewed and relies on insurance billing data, which can misclassify or overstate medical events.

Still, the researchers and pro-life medical professionals are urging the FDA to restore earlier, stricter safety requirements.

Commentary:

Even though this study is not peer-reviewed, the sheer size of the dataset and the findings are hard to ignore. Over 865,000 cases offer a substantial look at real-world outcomes, even if insurance data is less controlled than clinical trials.

While insurance claims may sometimes misrepresent causality, a margin of error would still leave tens of thousands of women facing serious risks that are barely acknowledged on drug labeling.

It’s deeply troubling that, according to the authors of the study, “Obama and Biden administrations removed important FDA safety protections that were required when the chemical abortion drug was first approved.”

When government agencies scale back safety requirements, it is often under political or commercial pressure — not because new evidence has suddenly proven the drug safer. Drug companies, naturally motivated by profit, will push products through with the minimum oversight allowed.

Women deserve full transparency. Choosing to undergo a chemical abortion is a serious decision, and patients have the right to be fully informed about possible life-threatening risks. The FDA’s outdated and overly optimistic labeling does a disservice to that right.

Even if the study exaggerated by 10% or 20%, the gap between official FDA statements and real-world data is still vast. This isn’t a small paperwork error; it could represent tens of thousands of women facing health crises they were never adequately warned about.

At minimum, further independent, peer-reviewed research must be conducted. The current evidence points to a serious information gap that needs urgent attention to protect women’s health and safety.

The Bottom Line:

A major new study suggests the abortion pill mifepristone may carry far greater risks than what the FDA label claims. Although the research has limitations, the size of the dataset and the severity of outcomes raise urgent questions about drug oversight.

Women’s health deserves better transparency and accountability from both the government and pharmaceutical companies.

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