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What You Need to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill

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What You Need to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill

Jul 28, 2023

The FDA has approved Opill, also known as the Minipill, for over-the-counter access without a prescription in the United States. Opill has been available in other countries for more than half a decade—it was approved for general use with a prescription in 1973. How is Opill different from regular combination birth control pills, and is it the right contraception option for you? Women’s health expert, Kirtly Jones, MD, goes into detail about how the progestin-only birth control pill works to prevent pregnancy and its risk and benefits before Opill is anticipated to be on pharmacy shelves in early 2024.

Episode Transcript

You don't want to get pregnant. You want to take oral contraceptives, but you're on your parent's insurance and you want privacy in this issue. Or you have insurance and called your primary care provider and have to get a prescription, but you need an office visit and the next appointment is in three months and you want your birth control now. Or you live in a small town, and your doctor's receptionist is your auntie, and you know small-town stuff. Or you don't have insurance and don't have a doctor. For any of these reasons, you would like to get birth control pills over the counter and soon you can.

Opill is FDA's First Over-the-Counter Birth Control Pill

In an action that many feel is long overdue, the FDA approved the progestin-only birth control pill for over-the-counter access without a prescription. Now, this form of birth control has been available over the counter in Great Britain for years, and it's available in many countries around the world over the counter. It was approved for general use with a prescription in 1973. It's now 2023. That makes it 50 years. So let's talk about what this means.

The company that makes something that's going to be called Opill, the company petitioned the FDA to put it over the counter, and this has been something that's been supported by the American College of Obstetrics and Gynecology and the AMA. It comes at a time when experts feel that access to this method of contraception, this low-dose progestin-only pill, and its very long history and track record of safety should be available over the counter.

Why did the FDA approve it for OTC use? Why now? Well, there have been calls to make progestin-only pills over the counter for years and years. However, pregnancy termination, for whatever reason, has become increasingly difficult for women to access around the country. It's raised the level of urgency to make sure that as many women as possible have access to effective and safe contraception, and making a pill over the counter does increase access for some women. A survey suggested that 77% of women, in 5,000 women who participated, wanted and liked the idea of getting the birth control pill over the counter. So it's popular, and the method is safe. And let's talk more about it.

What are Progestin-Only Birth Control Pills?

What is the progestin-only pill? In our business, we call it the minipill. But maybe it's for marketing over the counter, and it will be marketed over the counter as Opill. It was approved for use by prescription 50 years ago, and we have more than 50 years of data about its safety and efficacy. It's a very low dose of a progestin called norgestrel, and it's been used in contraception for more than half a century.

Comparing Progestin-Only Pills to Combination Pills

So how is it different from combination birth control pills, what you might call the regular pill? Well, the regular pill or combination birth control pills have estrogen and progestin in them. The side effects and the risks of combination birth control pills are largely related, if not exclusively to estrogen, and that includes high blood pressure and blood clots, and other conditions that are associated with high levels of estrogen. It turns out that a low dose of progestin-only does not have any of those risks.

The way you take the regular pill is to take it three weeks on and one week off. Or if you use a patch, it's three weeks on and one week off. Or a ring, you put it in for three weeks and take it out for one. Although, we all know you don't have to take that week off. However, with the low-dose pill, the Opill, or the minipill you need to take it every single day at about the same time.

Ideal Candidates for Opill

Well, who's right for the minipill instead of the combination pill? We have lots and lots and lots of data about breastfeeding. In fact, because estrogens after the birth of a child can suppress milk supply, but progestins do not, we've often given the minipill to use as contraception as a backup for women who are breastfeeding. So breastfeeding moms have taken it for a long time. Women who are over 35 and smoke or have high blood pressure, they kind of have a contraindication to taking estrogen. So the minipill has been good for them.

In fact, the minipill has been used by all women, and there are almost no contraindications, except perhaps breast cancer. So if you have breast cancer, then maybe a progestin-only method, whatever that method might be, is not for you. Now, there are a number of progestin-only methods. That includes a shot called Depo-Provera, which is a very high dose of progestin, or a leave-in norgestrel IUD, which is the IUD that goes in the uterus and puts a tiny dose of norgestrel, or an implant or these minipills. Because breast cancer can grow in the face of progestins, it's not recommended that women with breast cancer take this kind of contraception.

Also, progestins are metabolized by the liver. So if you have significant active liver disease, the minipill or the Opill or this progestin-only pill, the way we're going to be talking about it is not for you. But pretty much everybody else can take it.

Opill Usage and Effectiveness: Taking the Minipill as a Daily Contraceptive

Well, how do you take it? This minipill, this Opill is going to come in a pack of 28. Unlike the conventional pill, there's no row of inactive or placebo pills. You just take one pill a day every day. This is a really low dose. You can't really skip a day because then it won't work. And in fact, you should take it at the same time every day. You could put the pills with your toothbrush and take them at the same time you brush your teeth. Or do you put on your eyeliner or do you put on mascara every day? There's no day that you don't put on your eyeliner or mascara. Then stick it with that. You need to find a way that works for you, that you remember to take it every day. Buy a couple of packages of pills so that you don't run out.

How Does Opill Prevent Pregnancy?

Well, how does it work? Well, the combination pill with estrogen works by blocking ovulation. That's its primary mechanism of action. It also changes the cervical mucus so it's not so likely for the sperm to get up there. That's the progestin action. And it changes the lining, so it's not likely to be a good place for anything to grow. Its primary mechanism of action, although this is the combination pill with estrogen, is to block ovulation.

The Opill or the minipill or the progestin-only pill works primarily by thickening the cervical mucus and not allowing sperm to get up into the upper genital tract up to the egg. That's its primary mechanism of action. It also blocks ovulation in about a third of patients. Now, blocking ovulation is a good thing for your contraceptive method. But for women who it blocks ovulation, women may have irregular periods. So that can be a side effect. It's not a risk, but it's a side effect.

So that's how it works. It certainly has a failure rate. How well does it work? The failure rate, when it's used perfectly, same time every day, never missed, is about 2% per year, 1% to 2%, meaning out of 100 women who use it 1 or 2 will get pregnant. In regular use, understanding that somebody forgot it for six hours or somebody missed a day, the pregnancy rate in those groups is about 7 per 100 per year. So it's not perfect, but people aren't perfect. And perfect methods are methods like IUDs and implants, where you don't have to even think about it because it's always there, or having your tubes tied.

So it doesn't work perfectly, but it has a very good success rate. It works better when you take it the way you're supposed to, and it's much better, and it has a much lower failure rate than condoms and spermicides, which have higher failure rates in ordinary use, which means some people don't use them sometimes.

Common Concerns: Weight, Fertility, and Birth Defects When Using Opill

Will it make me fat? Well, that's not the right question. I think that what you really want to ask is, "Will I gain weight?" And remember that getting pregnant, when you don't want to, can really make you gain weight. A number of studies have addressed this specifically about birth control pills that are combination pills and the pill that we're talking about, the minipill. Some 22 studies looked at the evidence and found that there was minimal change in weight in women who took the progestin-only pill versus women who took nothing. Now minimum was maybe a couple of pounds a year. So it certainly could be that you could gain a couple of pounds a year more than you would anyway because American women, not all American women, but American women tend to gain weight. And so gaining weight when you're on the Opill may be because you're just gaining weight.

Well, the next question is, does it work less in women who are overweight? Well, that's been an issue in the morning-after pill, which is also progestin in much higher doses. And that morning-after pill works a different way in terms of helping you not get pregnant if you've already had sex. So does it work with women who are overweight and who are using it for contraception? And in general, a big series of studies that were published over the past several years have suggested that women who are obese are still good candidates to take the minipill.

Will it affect my future fertility? Well, the short answer is no, and the long answer is no, so no.

Does it cause birth defects? If you're taking this over the counter, then you're not necessarily getting a pregnancy test before you start. So maybe you're just a little bit pregnant and you start the minipill. If you were pregnant, does it cause birth defects? Well, that's been looked at carefully. A huge observational study from Denmark, looking at 880,000 live births in people who were taking birth control pills and the minipill before they got pregnant and in the first couple weeks that they got pregnant, showed that there was no increased risk of birth defects. Now, that's an important one because when it's over the counter, you have a lot of people who might grab the package and just start it without necessarily knowing whether they're pregnant or not. Of course, you wouldn't intend to take the pill because it doesn't work to stop a pregnancy. You don't want to take pills if you're pregnant. However, if you are, there's no evidence of an increased risk of birth defects.

Starting and Using Opill: Guidelines for New Users

Can you start it right away? So can you start it just any time? Clearly, it's most effective if you start it right after your period, but you can start it any time if you use a backup method for the first five days. So you can start it pretty much any time, understanding that it's not the morning-after pill. So if you start it and you might have had sex the night before and maybe you ovulated, it might not work for you because you might already be pregnant. However, you can start at any time, but use a backup method during the first five days.

Side Effects and Safety of Opill

We talked about the benefits, meaning not getting pregnant. There are risks and there are side effects. So let's talk about the side effects first.

The side effects, as we mentioned, might be related to irregular periods or irregular bleeding. So that will happen in those women who take it and whose ovulation is blocked. So that's not uncommon, and it's not a risky thing. It's just something you should be aware of. The side effects that come with the estrogen-containing pill, which include headaches and breast tenderness, and mood changes, might happen with the minipill, but they're much less likely to happen than with the regular pill.

In terms of risks, except for those patients who have breast cancer, there are really no risks to the minipill. The biggest risk of birth control pills is blood clots, and these are the ones with estrogen. Blood clots and high blood pressure don't happen in women who take the minipill.

So essentially the risks are almost zero. And the side effects, except for irregular periods and maybe some headache, breast tenderness, and mood changes, but unlikely, and a pretty small amounts of women experience those.

How Much Does Opill Cost?

Well, how much is it going to cost? We don't know how it's going to be marketed. The company that asked for it to go over the counter has not said how they're going to be pricing it. For women who have a doctor or a nurse practitioner, who get a prescription, under the Obama Care, you have to have your birth control paid for by your insurance.

Now, if you're not using insurance and you're buying it over the counter, will it still be paid for? So is it fair that people with insurance don't pay anything for their birth control and people without insurance would have to pay for it? No, it's not fair. But I think that Health and Human Services are going to take steps to ensure that private health insurance covers it and that it's covered for people over the counter, but it may not be, in which case we don't know exactly what it's going to cost.

Opill Availability and Access

When can I get it? The pill will be on store shelves probably in early 2024. Will it be available, where can I get it? Can I get it at any pharmacy? Well, there may be some pharmacies that won't carry it. But it should be next to the condoms and the emergency contraception in the big pharmacies that you might go to — CVS, Walgreens, at your Walmart, or at your Costco. There certainly are situations where very small pharmacies in small towns may not carry it, or you may not want to buy it at those little pharmacies where everyone knows everyone, and so women may still need to travel to get their over-the-counter birth control pill, either for access or for privacy.

So this is an important step for access to effective contraception for women who might be the most vulnerable and not having access, young women, women without insurance, women whose lives are too busy to take a day off for a doctor's visit with driving, waiting in the waiting room, getting seen, getting the prescription, going to the pharmacy, waiting for it to be filled, and getting started. So having something that you could swing by while you're doing your grocery shopping and just pick up your package of pills might be a significant improvement for many women.

Stay tuned because there will be more information as to how and where to get it and how much it will cost. In the meantime, women can get birth control pills in 22 states, including Utah, without a doctor's prescription by visiting a pharmacy and having the pharmacist do their evaluation. Now, this may not be accessible to younger women. In Utah, women have to be 18 or older to use this service in their pharmacy. The over-the-counter minipill will not have an age restriction. That is really important. And we're looking forward to this new access that will really be helpful for some women.