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FDA authorizes abortion drug distribution by mail

By Brian Buntz | December 17, 2021

FDA logoThe FDA has decided to allow dispensing of mifepristone from Danco Laboratories by mail using certified prescribers of pharmacies. The move also allows dispensing of the drug via telemedicine.

The agency had previously required that individuals obtain the abortion drug mifepristone (Mifeprex) in person.

FDA notes that the mail-order distribution model became popular during the pandemic, leading the agency to cease enforcing the in-person dispensing rule.

Some states, however, have moved to block the distribution of the drug, which is also known as RU486.

FDA indicates that the progestin antagonist mifepristone be used together with the drug misoprostol in the first 70 days of gestation. Misoprostol is a widely available prescription drug indicated as an ulcer treatment. FDA recommends that patients take mifepristone first and then misoprostol two days later.

Nearly half of U.S. states have either banned or limited the use of the mifepristone-misoprostol cocktail.

Demand for abortion pills has jumped recently as the Supreme Court considers the future of Roe v. Wade, according to Bloomberg Law.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

Comments

  1. JAnice says

    May 5, 2022 at 10:12 am

    Hello I need advice, Im 4 months pregnant when I took mifepristone 200 mg on 28th April but I didnt take the second pill which is the misprostol because I want to pursue my pregnancy. I cant sleep im bothered until now, does mife 200 mg can cause birth defects or any problems when I born my baby?
    Please help, thankyou!

    Reply
    • Brian Buntz says

      May 5, 2022 at 4:39 pm

      Hi Janice,

      This UK site found there are “insufficient data to determine if mifepristone exposure in monotherapy is associated with an increased risk of congenital malformation in the fetus.”

      It also concluded that “additional fetal monitoring may be warranted for ongoing pregnancies” just to be sure.

      A 2013 study concluded that the data were “reassuring” for continuation of pregnancy after mifepristone exposure.

      Please follow up with a physician.

      Best wishes,
      Brian

      Reply

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