Article Summary –
The FDA approved the abortion pill mifepristone 25 years ago, with Planned Parenthood reporting its safe use by 7.5 million Americans, while a recent unverified report by the Ethics and Public Policy Center claims a significantly higher rate of serious adverse events than reported in clinical trials. Experts like Dr. Stella Dantas and Ushma Upadhyay argue that the report manipulates data and emphasize that peer-reviewed studies show less than 1% of users experience serious complications, while Peter Lurie questions the political motivations behind the recent FDA safety review of mifepristone. Upadhyay also notes that the review might be aimed at reimposing in-person dispensing requirements and eliminating telehealth prescribing, which is crucial for patients in states with abortion bans post-2022.
The abortion pill mifepristone was approved by the U.S. Food and Drug Administration 25 years ago. According to Planned Parenthood Federation of America, it has been used safely by 7.5 million Americans as a private method for terminating pregnancies.
On May 14, Health and Human Services Secretary Robert F. Kennedy Jr. instructed the FDA to reassess the abortion drug’s safety. This order came after an April 28 report by the Ethics and Public Policy Center claimed adverse events associated with the drug.
The study, which Glenn Kessler reported in the Washington Post, was not peer-reviewed. It analyzed insurance claims for over 865,000 mifepristone abortions from 2017 to 2023, suggesting a higher rate of adverse events than reported in clinical trials. It found nearly 11% experienced sepsis, infection, or hemorrhaging within 45 days of taking the pill.
Stella Dantas, MD, president of the American College of Gynecology, told AFP Fact Check, “Long-standing, peer-reviewed evidence proves that medication abortion is safe.” She argues the report manipulates data. Previous studies show less than 1% had serious complications.
Ushma Upadhyay, a public health scientist, said anti-abortion advocates are pushing for a safety review, citing “junk science reports.” She questioned whether the review follows “gold standard science.”
Upadhyay noted anti-abortion advocates label any emergency room visit as a “serious adverse event.” She explained that people might visit emergency rooms due to lack of local healthcare providers, not because of adverse events.
Upadhyay’s study found 50% of abortion-related emergency visits involved observation only, with no treatment required. Hospital coding issues made it hard to determine if patients had surgical procedures or took mifepristone.
Sold in the U.S. as Mifeprex, mifepristone blocks the hormone progesterone, halting pregnancy development. Combined with misoprostol, it leads to uterine cramping and fetal tissue expulsion. In 2023, it accounted for 63% of U.S. abortions.
Peter Lurie, former FDA associate commissioner, expressed concern over the review, saying, “The singling out of a drug for scrutiny is unusual.” He questioned the motives behind the review, noting political influence.
Upadhyay suspects the review aims to justify restoring in-person dispensing requirements and restricting telehealth services, vital since the Supreme Court reversed Roe v. Wade in 2022. Telehealth had been patients’ only access to abortion care in states with bans.
She noted that insurance didn’t cover telehealth services until 2023, making pre-2023 insurance claim studies irrelevant for telehealth prescribing evaluation. Upadhyay emphasized published literature shows telehealth for medication abortion is as safe as in-person care.
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