FDA Approves First Orally Disintegrating Tablet for Birth Control: Daily Dose

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On July 25, 2024, we reported on the US Food and Drug Administration (FDA) approval of norethindrone acetate and ethinyl estradiol (Femlyv) for preventing pregnancy.

The approval

Femlyv is the first orally disintegrating tablet to receive FDA approval for pregnancy prevention, though norethindrone acetate and ethinyl estradiol have been approved in a swallowable tablet form for preventing pregnancy since 1968.

Femlyv should be dissolved on the tongue and followed with 240 ml of water. It should also be taken at the same time each day regardless of mealtimes. Side effects include vaginal candidiasis, nausea, headache, breast tenderness, menstrual cramps, acne, abnormal cervical smear, bacterial vaginitis, weight gain, and mood swings.

The recommended dosage of Femlyv is 1 tablet per day for 28 days, with no doses skipped or taken after 24 hours. However, the efficacy of this regime has not been evaluated in patients with a body mass index over 35 kg/m2. Initiation of the regimen is recommended on the first day of a patient’s menstrual period or the first Sunday after menstruation onset.

Femlyv’s safety and efficacy data is supported by studies comparing safety outcomes among women using combined oral contraceptives (COC) vs non-COC users. In 5 studies, breast cancer risk did not significantly vary between ever-user and never-users with effect estimates ranging from 0.90 to 1.12.

Despite this data, 2 studies have indicated increased breast cancer risk from recent COC use under 6 months. The relative risk increased by 1.19 to 1.33 among patients with current or recent COC use, with the risk increasing from longer use.

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