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BIG News from the FDA Today!

March 30, 2016 - By nwhn.org - 0 Comments

Today, the FDA announced major (and long overdue!) changes to the Mifeprex® (medication abortion pill) label.

 

Since its approval in 2000, medication abortion has proven to be an extremely safe and effective option to end an early pregnancy. During the past 15 years, doctors and researchers have been endorsing a more modern, evidence-based regimen than the original FDA approved label. But anti-choice politicians have used the outdated label as an excuse to pass medically- unnecessary laws that put women’s health at risk, for instance, requiring women to travel hundreds of miles and pay for a hotel simply to complete the multi-day regimen in a clinic instead of safely at home.

Today’s label change is welcome news for women’s health:

  • The new label allows for a lower dose of mifepristone (200 mg from 600 mg)
  • It increases from 49 days gestation to 70 days when women can take medication abortion
  • Follow-up does not have to be provided during an in-person clinic visit and the second part of the regimen, Misoprostol, can be taken at home
We fought hard for FDA to update the label based on scientifically-proven, evidence-based medicine. NWHN has a proud history as an FDA watchdog for drug safety and efficacy, and we fully support these changes. But as always, more still needs to be done. Medication abortion is still out of reach for some women because of medically-unnecessary regulations, like requiring special registration of providers who wish to offer it in their offices and prohibiting the medication from being dispensed in pharmacies.

 

We promise to keep fighting to make medication abortion even more accessible and affordable for all who may choose to use this safe and effective medication to end a pregnancy.

– See more at: https://www.nwhn.org/big-news-from-the-fda-today/#sthash.FJ44qt7E.dpuf

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