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Missouri sues FDA over mifepristone approval over hidden safety risk

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Missouri Attorney General Catherine Hanaway announced Thursday that the state is intensifying its fight against prescription drugs, targeting hospitals that contend with “health-threatening problems” and are being pulled from the market without “basic medical protection.”

Challenges to the Food and Drug Administration’s (FDA) approval of generic mifepristone produced by Evita Solutions, arguing that the drug’s risks are “well documented and worsen with further study.”

The lawsuit claims that the manufacturers relied on “weak safety standards” that were designed for “risky pregnancies such as ectopic pregnancy,” which can only be identified by human medical examination.

“Mifepristone sends women to the hospital with life-threatening complications, but drug companies continue to push new versions of it onto the market without basic medical safeguards,” Hanaway said. “Mail order drugs are dangerous when taken without human supervision, and Missouri will not stand by when manufacturers gamble with women’s lives.”

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Catherine Hanaway talks to reporters after Missouri Gov. Mike Kehoe announced his appointment as the next state attorney, Aug 19 19, in Jefferson City, Mo. (AP Photo/David A. Lieb)

The lawsuit builds on a separate Missouri challenge to what the FDA says is a “serious breach of safety protection” surrounding mifepristone.

The Tedral Law has long protected the mailing of abortion drugs, but distributors and telehealth networks have created a system across the country that tells women in every state whether to follow-up care in person or follow-up care.

Missouri, joined by Kansas and Idaho, is asking the court to block new approvals, restore pre-production safety nets that require drug shipments and distributors to ship abortion pills across the country in violation of federal law.

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Mifepristone and misoproprol

Misoprostol, left, and re-abortion drugs for abortion. (Robyn Beck/AFP via Getty Images)

Hanaway pointed to the label, noting that about 1 in 25 women who take chemical abortion drugs end up in the emergency room and many suffer from hemorrhaging, infection or need surgery. He said problems are more common when pills come in the mail without medical supervision.

“No primary care physician called mifepristone ‘as safe as Tylenol,'” she said. “That claim has always been false. Women end up in emergency rooms, and the manufacturers know it. If the FDA is reevaluating the safety of brand name drugs, then they need to stop printing new versions of the email before women get hurt.”

Hanaway’s filing comes as Washington lobbyists continue to push the FDA to tighten oversight of abortion pills and restore guardrails that have been rolled back in recent years.

The arrest was made by a doctor from California in Louisiana stomach pills

Mifepristone tablet box closure

MifePristone spirit tablets at a planned parenthood clinic in Iowa. (AP Photo/Charlie Nebrboll)

During a recent press conference, Sen. Josh Hawley, R-LAW.

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Sen. Bill Cassidy, R-LA., said other Republican senators wanted answers from the FDA about its decision to approve the new drug but they should get an answer.

Evita Solutions did not immediately respond to Fox News Digital’s request for comment.

FOX News’ Leo Brineno contributed to this report.

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