FDA approves first oral dissolvable birth control pill
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Key takeaways:
- The FDA approved a dissolvable hormonal contraceptive pill for people who have trouble swallowing.
- The pill was previously approved as a swallowable tablet.
The FDA approved the first orally disintegrating birth control pill for people who have difficulty swallowing their medication, the agency announced in a press release.
The dissolvable combined oral contraceptive of norethindrone acetate and ethinyl estradiol pill (Femlyv, Millicent), was first approved in the U.S. for the prevention of pregnancy as a swallowable tablet in 1968.
"Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication," Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA's Center for Drug Evaluation and Research, said in the release. "There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges."
According to the full prescribing information, the pill should be taken once daily by placing on the tongue, allowing the pill to disintegrate and then drinking 8 oz of water. Pill packs come with 24 green “active” pills and four white inert pills, all taken once daily at the same time of day.
The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings and weight gain.
Perspective
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Orally disintegrating tablets, also called ODTs, which are pills that are meant to dissolve rapidly when placed on tongue, have a few different advantages. The most intuitive one is that they provide a way for people who have difficulty swallowing pills to take medications orally. ODTs are also helpful for people who suffer from nausea, as a dissolvable pill can be easier to take than having to swallow a medication whole. This can be helpful for birth control pills specifically since some patients can become nauseous due to the medication. They can also lead to more rapid onset of medication effects. Because the pills completely dissolve before reaching the stomach, they can be absorbed into the bloodstream through the mucosa of the mouth, throat, and esophagus, whereas most oral medications do not start to absorb until they are broken down by stomach acid. Since they are absorbed before reaching the stomach, their absorption is also less affected by the contents of the stomach. While the concentration of medication absorbed into the bloodstream can be lower for oral medications after a big or high-fat meal, this is not the case for ODT medications, which are not as sensitive to food intake.
The efficacy is the same for the different methods of oral contraceptive pills. Though the different methods can ultimately lead to different levels of estrogen and progestin in the bloodstream, the amount of these hormones that does get absorbed is enough for the pills to reliably prevent pregnancy, regardless of the route of administration.
It is important to remind patients that chewing or crushing pills that are not labeled as orally dissolvable medications can decrease their efficacy. Pills may have certain coatings that prevent them from dissolving too early because they need to be absorbed in certain parts of the gastrointestinal system. Extended- or sustained-release pills may need to break down over a certain time period to work properly, and chewing or crushing them could lead to a larger dose than normal being released all at once, causing uncomfortable or sometimes serious side effects. Conversely, it could result in suboptimal absorption of the drug, leading a patient to get a lower dose of the medication than intended.
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