For the first time in the U.S., the Food and Drug Administration (FDA) has given its approval to an oral contraceptive product that will be available without a prescription. We expect that Opill will begin to appear in pharmacies, grocery stores, and online in early 2024.
From the FDA press release (July 13, 2023):
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
A planned pregnancy allows the mother to optimize her health and prepare for the changes her body will undergo as the baby develops. She is more likely to receive early prenatal care to help her toward the best possible outcome for her baby and herself. Your doctors here at Sparks & Favor appreciate the FDA’s intention to make safe, effective birth control available to women with the least possible inconvenience.
Convenience is a very important factor in determining whether any birth choice will be used consistently to reduce the likelihood of an unplanned pregnancy. But we encourage any woman seeking birth control to learn about which options would be safest and most effective for her individual situation. This is not a one-size-fits-all choice.
What is Opill?
First, norgestrel, the active ingredient in over-the-counter Opill, is not a new medication. Norgestrel is a progestin. It first received FDA approval for birth control in 1973. It protects against pregnancy by thickening the mucous your cervix secretes making it less likely for sperm to pass. It prevents ovulation, although not consistently. It also thins the lining of the uterus. Opill does not contain estrogen.
The FDA chose to make this progestin-only pill available without a prescription for several reasons. The agency determined—when used properly—Opill is safe and effective for preventing pregnancy. The FDA also decided that the information on the product label was easy to understand and was thorough enough for a woman to know whether the product was safe for her and use to it properly without consulting a health care provider.
Birth control methods containing only progestin include both pills and injections. Before the FDA’s decision, these have been available by prescription only. We may recommend them to patients whose personal health history makes estrogen-containing pills an unacceptable risk. Women with high blood pressure, other cardiovascular disease, or a history of blood clots (deep-vein thrombosis) can take progestin-only pills without increasing risk.
Progestin-only pills can be a good choice for breastfeeding women, especially during early weeks when combined-hormone methods may reduce milk supply.
Disadvantages of Progestin-only pills
Progestin-only pills are less effective than combination pills (containing estrogen) in preventing pregnancy. This is because they do not prevent ovulation as well. Pregnancy rates with typical use may be as high as 1 in 10. Pregnancy risk increases if the pill is not taken at a very consistent time each day. Users should read the package instructions carefully to understand the need for a back-up method of birth control if a pill dose is delayed by more than 3 hours. Users of estrogen-containing pills should also try to take them at a consistent time of day, but these pills usually remain effective if the delay is short (less than 24 to 48 hours) and the rest of the pills in the cycle have been taken consistently. Progestin-only pills are more often associated with irregular spotting or bleeding than what is typical with combination pills.
Other side effects of the progestin-only pills can include acne, weight gain, and increase in facial or body hair (hirsutism). We sometimes prescribe another non-estrogen pill (Slynd) for women who cannot use birth control containing estrogen. Slynd contains a different progestin than Opill. Acne, weight gain, and hirsutism are less likely. It also prevents ovulation more effectively than other progestin-only pills, so it is a more forgiving option if you miss a dose. Slynd is not available over the counter.
For more information about progestin-only birth control methods see American College of Obstetricians and Gynecologists’ Q&A Progestin-Only Hormonal Birth Control: Pill and Injection.
Should you try the over-the-counter pill?
The answer depends on which advantages you are seeking. A woman who does not have a regular provider will certainly benefit from having immediate access to a contraceptive method that is totally under her control. Without a doubt, convenience is extremely important. The new over-the-counter option is safe for most women. Opill’s label warnings explain who should not use it. You should still consult your provider if the label warnings cause you any confusion or uncertainty.
On the other hand, all women should have an annual well-woman exam. Birth control is only a small part of ensuring your reproductive health in every stage of your life. Why not take advantage of the opportunity to discuss birth control options with your doctor and choose the best option for you!
Remember that we are available to our patients by phone or through the patient portal for prescription refills during regular office hours. If you are a patient, but do not have a current prescription, you can speak to one of our nurses about your immediate need for a refill. She will review your chart to assure that you have no risk factors that would prevent her from offering you a short-term refill.
Note: most private insurance and also plans purchased through the healthcare marketplace are required to provide free access to birth control. It is not yet clear whether over-the-counter birth control will be included in this mandate.