How does the new OTC birth control pill compare to prescription ones?

Q: How does the new OTC birth control pill compare to prescription ones? – Lili C.

A: The newly approved OTC birth control pill is a low-dose progestin-only pill that was previously prescription-only. It is very safe and highly effective.

This particular pill (norgestrel 0.075 mg, now marketed as Opill) was initially approved for prescription use in the United States in 1973. It was sold as “Ovrette” until 2005 when the company stopped producing it due to low consumer demand. It is one of a family of birth control pills that are low-dose, progestin-only pills (contain no estrogen). Called POPs or MiniPills, these types of pills have been around a long time and have an excellent and proven safety profile, but they have historically been much less popular than estrogen-containing pills.

As a low-dose, progestin-only pill, this pill is very safe. There have been no documented serious side effects, and it is safe for people with migraine headaches, blood clotting problems, high blood pressure, and current breastfeeding. The only people who should not use this pill are those with severe liver disease, certain types of weight loss surgery, or current or past breast cancer.

In general, this pill has few side effects. The most common is irregular vaginal bleeding (this is a trade-off for being low-dose and estrogen-free). This is not dangerous but can certainly be annoying (and is a reason for its lower popularity). Other possible side effects, common to all birth control pills, include nausea, breast tenderness, and headaches, but these are usually mild and often go away over time.

The other drawback of being estrogen-free and low-dose is that it is finicky. This pill MUST be taken at the SAME time EVERY day. If a person is more than 3 hours late in taking this pill, they must use a condom as back-up birth control. When taken perfectly, the risk of pregnancy with this pill is only 1-2% over one year of use. But such perfect use is difficult for most people! So, real-world pregnancy risk with this method is estimated to be 5-9% over one year. This is a higher pregnancy risk than many of the prescription methods of birth control.

A few notes: There is no placebo, or sugar-pill week with these low-dose progestin-only pills – you take a pill EVERY day, even during the menstrual period. This pill can also NOT be used as emergency contraception (it is not effective if taken only after sex has occurred). Due to the lack of estrogen, this pill is less likely to be effective in treating menstrual disorders (such as PCOS and irregular periods), ovarian cysts, and endometriosis. Lastly, we do not yet know what the pricing for this pill will be, nor whether it will be covered by health insurance plans.

In their decision-making for over-the-counter status, the FDA considers not just safety and efficacy but also whether people can properly understand and follow instructions for the medication without a clinician’s or pharmacist’s guidance. This was less clear in the studies, but given that a pregnancy risk of even 5-9% is far better than that of other *over-the-counter* birth control methods (condoms have a 13% pregnancy risk in one year), they decided to approve it.

Bottom line: The availability of a very safe, effective, over-the-counter birth control pill will be a welcome additional tool for preventing unwanted pregnancies, especially if it is reasonably priced. It could be a huge benefit for those with difficulty accessing prescription birth control. It is, however, a somewhat finicky pill with a common side effect of irregular bleeding, so many people will still prefer to use prescription-only methods.