The FDA alters guidance to say morning-after pills are not abortion pills

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Labels of Plan B One-Step had previously stated—without scientific evidence—that the pill might block fertilized eggs from implanting in the womb.

Plan B One-Step is an emergency contraceptive used to prevent pregnancy after another contraceptive fails or after unprotected sex. It works before the release of an egg from the ovary. As a result, it stops or delays the release of an egg. It contains a higher dose of levenorgestrel than birth control pills and works in a similar way to prevent pregnancy.

The US Food and Drug Administration (FDA) recently updated the pill’s post-market drug safety information, clarifying that Plan B One-Step is not an abortifacient. It will not work, the information states, if a person is already pregnant. There is no scientific evidence to support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore, it does not terminate a pregnancy.

The mechanism of action was modified on the Drug Facts label and Consumer Information leaflet this year because the applicant for Plan B One-Step submitted a supplemental new drug application—a labeling supplement—as amended, to the FDA requesting approval to modify some of the mechanism of action information on the Drug Facts label and in the Consumer Information Leaflet.

The information edited, according to the FDA, included removal of certain wording about fertilization and implantation. Prior to their edits, the information about the mechanism of action was in the “Other Information” section of the Drug Facts label and was moved to the Consumer Information Leaflet. They specified that the mechanism of action is rarely included in nonprescription drug labeling and is not required under the FDA’s regulations for nonprescription labeling, as the information is not needed for the safe and effective use of nonprescription drugs in general. However, these edits to the language and mechanism of action are important for consumers to know, especially amid the current reproductive rights landscape.

Reference

Center. Plan B One-Step Information. U.S. Food and Drug Administration. Published 2022. Accessed January 13, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/plan-b-one-step-15-mg-levonorgestrel-information

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