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Is it time to review the prescription of restrictions on mifepristone in abortion? : Shots



Mifepristone is a medicine used to end early pregnancy and relieve the symptoms of miscarriage. This is severely restricted by the FDA.

Adria Malcolm


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Adria Malcolm

Mifepristone is a medicine used to end early pregnancy and relieve the symptoms of miscarriage. This is severely restricted by the FDA.

Adria Malcolm

Mifepristone is one of two regimens approved by the Food and Drug Administration for ending early pregnancy. It is also prescribed to reduce the severity of spontaneous abortion symptoms. But it is highly regulated in ways that can make it difficult for women to obtain it. Along with its approval in 2000, the FDA restricted its use due to safety concerns.

In a promising article published this summer in the New England Journal of Medicine former FDA Commissioner Dr. Jane Henney and co-author Dr. Helen Gayle argued that the agency should reassess whether such measures still exist. recent studies have shown that mifepristone is both effective and safe.

Henny, who was the FDA's commissioner when the restrictions were imposed, explains that the agency put mifepristone in its risk drug program, risk assessment strategies and risk mitigation. This program includes drugs such as antipsychotic drugs and drugs. Mifepristone is one of the most restricted of all medicines in the REMS program, Henny says.

The FDA requires doctors and clinics to be certified for prescription, and women must go to a clinic, medical office, or hospital to receive it – rather than taking it to a pharmacy. In 2016, the agency partially revised restrictions on extending the gestational age limit for mifepristone and eliminating the requirement for follow-up of a person after taking the drug.