Impact of the FDA's Abortion Pill Label Change

On March 29, 2016, the U.S. Food and Drug Administration (FDA) approved updated labeling for mifepristone (also known as the abortion pill or by its brand name, Mifeprex®), which is prescribed along with another medication, misoprostol, for medication abortion in the United States. The FDA’s move to change the label is important in many ways. Although off-label use of drugs is generally accepted in the United States, many clinicians see FDA labels as guides to appropriate and legally defensible clinical practice. First and foremost, the label update reaffirms that medication abortion is very safe and highly effective. It also has the potential to increase access to medication abortion in this country.

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