By Deanna Neff HealthDay Reporter<\/b>
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MONDAY, Sept. 29, 2025 (HealthDay News) \u2014 The U.S. Food and Drug Administration (FDA) is reviewing the safety of mifepristone, a drug used in medication abortions<\/a> for 25 years, amid a push from conservative state attorneys general and anti-abortion groups.<\/p>\n The announcement was made in a letter from Health and Human Services Secretary Robert F. Kennedy Jr<\/a>, according to CBS News<\/em>.<\/p>\n The review, spearheaded by Kennedy, focuses on compliance with an FDA safety program aimed at ensuring a drug\u2019s benefits outweigh its risks. He said it will review \u201cthe latest data\u201d and “real-world outcomes and evidence” related to the drug’s safety and effectiveness.<\/p>\n The review follows action in 2023 by the Biden administration allowing patients to receive mifepristone by mail and through telehealth appointments. Conservatives have criticized the move. A majority of abortions in the U.S. are now done using medication, with mifepristone being the first of a two-drug regimen.<\/p>\n The letter from Kennedy cited a study by the Ethics and Public Policy Center (EPPC) that suggested “potential dangers that may attend offering mifepristone without sufficient medical support or supervision.” The letter also mentioned FDA data, which reported 2,740 adverse events from 2000 to 2012, including 416 requiring blood transfusions, CBS News<\/em> reports. <\/p>\n The EPPC study said nearly 11% of women experience a serious adverse event. Other sources contest that figure.<\/p>\n “Other data sources show the rate of serious complications to be much lower, at less than 1 in 200,” CBS News<\/em> medical contributor Dr. C\u00e9line Gounder<\/a> said.<\/p>\n Advocates for the drug\u2019s use insist it has a strong safety record.<\/p>\n “More than 100 studies confirm mifepristone’s exceptional safety record,” the American Civil Liberties Union (ACLU) said in a statement. It noted that the drug has been used by more than 7.5 million women since its initial FDA approval in 2000. It is approved to terminate pregnancy through 10 weeks of gestation.<\/p>\n While the review could lead to changes in how the drug is prescribed, such as limiting its availability through telehealth or to certain types of health care providers, experts suggest an outright ban is unlikely.<\/p>\n Gounder said it would be “an extraordinary step” for the FDA to withdraw its approval for mifepristone and would likely face immediate legal challenges.<\/p>\n While Kennedy’s letter did not provide a timeline for completion of the review, he said the FDA would keep states informed of its progress.<\/p>\n More information<\/strong><\/p>\n The U.S. National Library of Medicine has more information about mifepristone<\/a>.<\/p>\n