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Restrictions On Abortion Medication Deserve A Second Look, Says A Former FDA Head


Added 08-20-19 12:07:01pm EST - “The FDA heavily restricted mifepristone ?" a drug that ends early pregnancies ?" when it approved it 19 years ago. A former FDA commissioner asks whether the current restrictions should be revisited.” - Npr.org

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Posted By TheNewsCommenter: From Npr.org: “Restrictions On Abortion Medication Deserve A Second Look, Says A Former FDA Head”. Below is an excerpt from the article.

Mifepristone is a medication used to end early pregnancies and to relieve the symptoms of miscarriage. It's heavily restricted by the FDA. Adria Malcolm hide caption

Mifepristone is a medication used to end early pregnancies and to relieve the symptoms of miscarriage. It's heavily restricted by the FDA.

Mifepristone is one of a regime of two drugs approved by the Food and Drug Administration to end an early pregnancy. It's also prescribed to help reduce the severity of miscarriage symptoms. But it's heavily regulated in ways that can make it hard for women to obtain. Parallel to its approval in 2000, the FDA restricted its use due to safety concerns.

In a perspective article published this summer in the New England Journal of Medicine, former FDA commissioner Dr. Jane Henney and coauthor Dr. Helene Gayle argue that the agency should reevaluate whether such measures are still necessary, and take into consideration recent studies that show mifepristone is both effective and safe.

Henney, who was FDA commissioner when the restrictions were imposed, explains that the agency placed mifepristone in its program for risky drugs, Risk Evaluation and Mitigation Strategies. This program includes drugs such as antipsychotic medications and narcotics. Mifepristone is one of the most restricted of all drugs in the REMS program, Henney says.

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