You Can Take This Birth Control Pill Without Swallowing It …C0NTINUE READING HERE >>>
Key Takeaways
The FDA approved the first dissolvable oral birth control medication. The approval provides a new option for people who want to use an oral contraceptive but have difficulty swallowing pills.
The Food and Drug Administration (FDA) approved the first oral birth control that dissolves in the mouth. The approval provides more contraceptive options, especially for people who can’t or don’t like to swallow pills.
“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,” 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 a statement.
Femlyv (norethindrone acetate and ethinyl estradiol), is a once-daily hormonal birth control that contains a combination of estrogen and progestin. It’s approved for use to prevent pregnancy in women and people who menstruate.
“Having a new method on the market is always something that I am excited about because it means that more people will have an option that works best for them,” said Michael Belmonte, MD, clinical instructor of obstetrics and gynecology at George Washington University.
“Younger patients who may not already be taking medicines for other conditions or have just started the process of taking medicines could really benefit from this. There are also people who have certain swallowing disorders that may be able to benefit from this,” he added.
What to Know About Femlyv
Femlyv is a hormonal medication that combines norethindrone acetate (a progestin) and ethinyl estradiol (an estrogen).
The combination of norethindrone acetate and ethinyl estradiol has been available since 1968 as a contraceptive. It’s also approved under various brand names to help alleviate symptoms of menopause, such as hot flashes.
Femlyv comes in a package of 28 tablets. The drug should be taken every day at about the same time. The prescribing label says the user should place a tablet on the tongue, where it should dissolve, and then drink 8 ounces of water. Each pack comes with 24 green “active” pills and four white inert pills.
Side Effects and Contraindications
The side effects of Femlyv align with most similar oral contraceptives. According to the FDA, the most common adverse reactions are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, mood swings, and weight gain.
The FDA said that the medication had not yet been tested in people with a body mass index (BMI) of 35 or higher.
In a 2013 meta-analysis, the authors identified five studies comparing the effectiveness of norethindrone acetate and ethinyl estradiol in women with a BMI of 25 or higher to those who had a BMI under 25. One study found a greater risk of pregnancy in people with a higher BMI, while the other four studies found no statistically significant difference.
“There is a gap sometimes when we’re talking about people with larger bodies and what methods may be best for them,” Belmonte said. “That being said, this is a very standard process of approval via the FDA, and given the track record of other similar medications using the same components, we anticipate that it should be acceptable to people of all body sizes.”
The Femlyv label also warns the drug may not be safe for people ages 35 years and older who smoke due to the elevated risk for certain cardiovascular issues, including stroke and blood clotting.
Belmonte said that people who are considering Femlyv or other estrogen-containing drugs should check with a health provider about whether those medications are right for them. Some of the reasons why someone may avoid estrogen-containing medications include a history of breast or endometrial cancers, liver disease, and a history of blood clotting.
What This Means For You
Whenever you take a new medication, make sure to read the directions before use, so you can be sure it’s most effective. You can find the full information about how to use Femlyv and the potential risks on the FDA label.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Lopez LM, Bernholc A, Chen M, et al. Hormonal contraceptives for contraception in overweight or obese women. Cochrane Database Syst Rev. 2016;2016(8):CD008452. doi:10.1002/14651858.CD008452.pub4
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