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OPill: The Latest OTC Contraceptive Option

Did you hear the big news? On July 13, 2023, the FDA officially approved the first over-the-counter birth control pill available in the United States! This OTC pill, called “OPill,” differs from traditional prescription birth control pills in a few ways. Here, we’ll dive into some of the key points to know if you are considering this contraceptive option.

OPill is a progesterone-only contraceptive pill that uses Norgestrel, which is a type of progesterone. OPill does not contain any of the hormone estrogen. This is a key difference from traditional prescription combination birth control pills, which contain BOTH the hormones estrogen and progesterone (see Praise For the Pill blog post for details about how traditional pills work). Norgestrel is a form of progesterone; different birth control pills contain different types of progesterone to prevent pregnancy, and there is not one type of progesterone that is “better” than another type, per se. However, because Opill does not contain any estrogen, it MUST be taken at the same time every day in order to prevent pregnancy.  This may make it less effective for preventing pregnancy with typical use when compared with combination pills.

What does that mean? Read on for the details.

In clinical trials, Opill was 98% effective at preventing pregnancy when taken PERFECTLY. Perfect use means the pill is taken at the same exact time every day, with no missed or late doses. 98% efficacy means that 2 in 100 women will become pregnant in 1 year of use of OPill, making it a highly effective contraceptive option. In fact, this makes Opill is the MOST effective OTC contraceptive option available [when compared with condoms and spermicides]. However, perfect use is usually only seen in clinical trials. In real life, people aren’t perfect. Sometimes we forget to take a pill or take it a little later than we intended. 

If a woman takes OPill 3 hours or more late, there is a risk for contraceptive failure: ie- unintended pregnancy. Because of this, the progesterone-only pill should be taken as soon as it is remembered and back up contraception, such as condoms or abstinence, should be used for the next two days. In contrast, traditional combination birth control pills have a little more wiggle room with late doses. If a woman takes her combination pill a little late or even misses 1 pill, as long as it is taken as soon as it is remembered, there is no need to use backup birth control. If multiple doses are missed, however, then backup birth control should be utilized.

OPill is safe for most prospective users to take, with very few circumstances in which someone should avoid it. Because OPill does not contain estrogen, it does not carry the same [relatively rare] risks for elevated blood pressure or cardiovascular concerns that combination pills may pose (again, see Praise for the Pill Blog for details on this). Women with any personal history of breast cancer should NOT take OPill. 

OPill is expected to become available to consumers in early 2024, according to its manufacturer. Information about OPill’s cost and insurance coverage is still unclear at this time, but average birth control pill costs currently range from $0 to $50 per month, depending on health insurance coverage. Having an over-the-counter birth control pill option has the potential to help millions of people avoid unplanned pregnancies, which currently account for half of all pregnancies in the United States and can lead to other potential complications.

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