The United States Food and Drug Administration (FDA) recently approved a new over-the-counter birth control option. Here’s what it means for women in the country.

What is the medication?

The “Opill” is made from the hormone norgestrel, which belongs to the progestin family. It doesn’t have estrogen in it, but the norgestrel stops the egg from fully developing each month. When it can’t develop, it can’t accept sperm for fertilization, preventing pregnancy.

Opill is a hormonal birth control option like one you could receive from your gynecologist. It’s not an emergency contraceptive or an abortion pill.

Is it reliable?

Clinical trials show Opill is around 98% effective in preventing pregnancy in a perfect-use scenario. Like other birth control pills, it should be taken every day at the same time for it to be most effective. If you miss the dose by three or more hours, use a backup birth control method, like a condom.

Using it correctly, only 2 in 100 women will get pregnant during the pill’s yearly use.

Some research indicates hormonal birth control could be less effective in overweight people. However, there is no definitive answer yet on whether that is true. If you are plus size and have concerns about potential ineffectiveness, consult your gynecologist about the best option for your body.

Who can take it?

Since the pills don’t have estrogen, there are few contraindications, which makes it as safe for women as many other over-the-counter medications. However, there are some cases where it’s best to avoid this birth control option.

You shouldn’t take Opill if you have or have had breast cancer, are pregnant, or use another internal birth control option like a patch, implant, or intrauterine device (IUD). Don’t take the pill with an emergency contraceptive option. Talk to your doctor before using the pill if you take medications for seizures, tuberculosis, pulmonary hypertension, human immunodeficiency virus infection, and acquired immune deficiency syndrome.

Also, check with a doctor or pharmacist if you ingest a St. John’s Wort supplement. The herb is known to lower the effectiveness of some birth control options.

What are potential side-effects?

Like with all medications, there are potential side effects for Opill. Common ones include nausea, breast tenderness, irregular vaginal bleeding, and headaches. They’re typically mild and will likely go away, but it’s best to contact your doctor if they’re severe or persistent.

How much does the pill cost?

Opill’s manufacturer is the Dublin-based Perrigo Company. As of August 2023, it has not yet announced an in-store or online purchase price. If it aligns with other contraceptive costs, it could range from $0 for people with insurance to around $50 for those without. However, it’s unclear if that will be the case for this medication.

How will it change gynecology appointments?

With OTC access to a hormonal birth control option, you’ll no longer have to rely on a prescription from your gynecologist or primary care physician (PCP) to prevent pregnancy. However, you should still attend your annual exams.

Seeing a doctor is for more than refilling a contraceptive. Breast exams, pap smears, and other screenings are crucial for catching potential problems early. Each year, around 13,000 women in the U.S. get diagnosed with cervical cancer alone, leading to thousands of deaths. The annual screenings your gynecologist or PCP provides can help catch any signs of illness early enough to treat.

When you see your gynecologist or another provider, ensure they know what you’re doing for birth control so they know what could or could not interact with it and how to better care for you.

What do the professionals say?

The American College of Obstetrics and Gynecology applauded the decision to allow Opill to be an OTC medication. In a joint statement, President Verda J. Hicks, MD, FACOG, and interim CEO Christopher M. Zahn, MD, FACOG, expressed their full support for providing a safe birth control option without refilling a prescription or waiting for a doctor’s appointment.

The American Medical Association agreed and pushed for the pill’s approval since the FDA began considering it. Board Member David H. Aizuss, M.D. pointed out inaccessibility was often the reason patients don’t use oral contraceptives.

Planned Parenthood is also on board. President and CEO Alexis McGill Johnson praised the decision, saying it removes an unnecessary barrier to accessing a fundamental and essential part of public health care.

When will you have access to the pill?

Perrigo Company says Opill should be available in stores and online beginning in early 2024.

Improving birth control access in turbulent times

With the overturning of Roe v. Wade and health care restrictions cracking down across the country, women need access to birth control. The ability to get it over the counter could help millions take their reproductive health into their own hands. When Opill rolls out, it will hopefully improve lives throughout the U.S.

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