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FDA Eases Restrictions on Abortion Medication

By Margaret Steele
HealthDay Reporter

WEDNESDAY, March 30, 2016 (HealthDay News) — The U.S. Food and Drug Administration is making it easier for women to obtain a medication that induces abortion.

Under changes announced Wednesday by the agency, women in most states who want the drug, called mifepristone (Mifeprex), will need to make just two trips to a doctor, instead of three.

They’ll also have 10 weeks from the start of their last period to use the medication to terminate pregnancy, up from the prior cutoff of 49 days, The New York Times reported.

Additionally, the FDA is reducing the drug’s dosage from 600 milligrams to 200 mg, reportedly reducing the cost of mifepristone and its potential side effects.

Abortion-rights advocates welcomed the label changes.

“Unlike state and federal anti-choice laws that restrict a woman’s access to an abortion, the FDA decision to make mifepristone available to more women in this country is based on science that shows this usage is safe and medically sound,” said Ilyse Hogue, president of NARAL Pro-Choice America, in a statement. “It is high time to put medicine back into the hands of medical professionals and take it out of politicians’ hands.”

An anti-abortion group took a different view, however.

“The new label affirms the deadly realities of chemical abortion and underscores the need for in-person patient examination and follow-up care as well as the fact that the abortion drug regimen presents serious risks to women’s health,” Anna Paprocki, staff attorney for Americans United for Life, told the Washington Post.

But abortion rights advocates and many physicians said the original abortion-medication labels were outdated and contradicted sound medical practice. They also had argued that states such as Texas, North Dakota and Ohio — which required physicians to follow the label restrictions — erected barriers to abortion, the Times said.

“This is a huge step in increasing access to medication abortion and it comports with the scientific evidence,” Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, which tracks women’s reproductive health issues, told The Times. According to the institute’s latest figures, medication abortions accounted for about 25 percent of all abortions in 2011, she said.

The American Congress of Obstetricians and Gynecologists also backed the FDA decision. “The updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices,” it said in a statement.

The drug, formerly known as RU-486 and approved by the FDA in 2000, works by blocking receptors of progesterone, a hormone needed in pregnancy, and is used with the drug misoprostol to end a pregnancy.

More information

The U.S. National Institute of Health talks about the signs of pregnancy.





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