In July 2023, the progestin-only birth control Opill became the first hormonal contraceptive to receive over-the-counter (OTC) approval by the FDA. The “mini-pill” hit physical shelves and became available for online purchase with no age restrictions in March 2024. Advocates hailed these as positive, necessary, and long-overdue steps to reduce barriers in women’s access to birth control. Natural Womanhood opposed Opill’s OTC approval, due to concerns that lack of medical screening would exacerbate the not-so-mini risks associated with progestin-only contraceptives. Here are five facts you might not have heard about Opill.
1. The FDA had some serious doubts about the Opill manufacturer’s research study
Perrigo, the company that produces Opill, performed a study in which women recorded their use of the mini-pill for up to six months without a doctor’s supervision. However, there were a few… unusual things about the study. The FDA questioned unexplained data showing that 30% of participants reported taking more pills than the company supplied them with. Reviewers additionally questioned claims about Opill’s effectiveness because the study was far smaller than most of its kind.
The FDA also expressed concerns that Opill could worsen health problems for women with pre-existing conditions. Half of the women in the Perrigo study with a history of irregular bleeding incorrectly believed Opill was appropriate for them, despite being “instructed to talk to a doctor first, because [irregular bleeding] could indicate a medical problem.”
Disappointingly, the FDA still approved Opill, thereby affirming the manufacturer’s claim that women “of all ages” are able to screen themselves without a doctor’s help to determine if Opill is right for them.
2. Opill is a no-go for women taking certain medications, those with irregular or unusual bleeding, and those with personal or family history of breast cancer
Women with irregular or unusual bleeding (such as spotting between periods) aren’t the only ones who should be wary of the mini-pill. Opill should not be taken at the same time as several different types of medication (and some herbal supplements), including those that treat high blood pressure and HIV, according to Opill’s label and website. Women with a personal or family history of breast cancer should not take Opill either (more on this below).
The potential complications associated with Opill—including breast cancer, cervical cancer, breast cancer, liver issues, and decreased bone density—are not intuitive. Users are advised to read the drug label carefully, but let’s be honest with ourselves: How many of us peruse the fine print before pulling an item off the shelf at our local drugstore? Especially given the widespread celebration of Opill’s OTC approval, women are likely to hold the misconception that the drug comes with little to no risk—after all, they wouldn’t just put it out there on the shelf for anyone to purchase if it wasn’t safe, right?
3. Opill increases risk of breast cancer
In March 2023, The Washington Post published a baffling article intended to assuage concerns about the link between breast cancer and progestin-only contraception. It cited a British study which found that, indeed, women’s risk for cancer was increased 20-30% by taking birth control–but not to worry! That’s no different than the risk from the combination pill [1]. The article failed to note that for women who took oral contraceptives for 5 years or longer, the risk of developing breast cancer remains elevated for up to 10 years after stopping it [2].
The comforting language of the Washington Post article rings disconcertingly hollow when considering current breast cancer statistics reported by The American Cancer Society. Breast cancer is the second most common type of cancer and the second most deadly cancer in women (lung cancer is the most lethal). And rates have been increasing in recent years, especially among younger women. Currently, about 10% of new breast cancer cases occur in women under 45, with that rate increasing by 1% annually.
Still, because breast cancer remains more prevalent in older women, it’s not top of mind for many young women, especially if they haven’t had close family members affected by the disease. Indeed, although a history of breast cancer is the top (often the only) reason women are told not to take Opill, preliminary research from the Perrigo study found that some women with a history of breast cancer were unaware that Opill was inappropriate for them.
4. Women in rural and underserved areas deserve better than mail order contraceptives
A recent article from The Daily Yonder points to the alarming rate of closure among pharmacies in small towns and rural areas, forcing millions of women to travel long distances to seek medical care. While this issue certainly deserves to be noticed and addressed, making Opill available over the counter does nothing to address it. Moreover, it may actually put these women at greater risk: if there is a more convenient option available, most people will take it without a second thought. This situation almost guarantees that a woman will not consult a medical provider about taking the mini-pill, and she will still be far from medical care if she does experience any serious side effects or adverse reactions.
Furthermore, unlike birth control prescribed by a medical professional or pharmacist, OTC birth control is not covered by insurance, meaning that women who opt for Opill will pay for it out of pocket. A one-month supply currently costs around $20 per month.
5. With typical use, Opill is actually less effective than FAMs at preventing pregnancy
Opill boasts 98% effectiveness in preventing pregnancy, but only with perfect use (taking the pill every single day around the same time). Less frequently acknowledged is its “real-world” effectiveness rate, which takes into account typical rates of incorrect use: about 91%. That’s actually much lower than fertility awareness methods (FAMs), which range from 92% to 98% effectiveness–and that’s with typical use.
Final thoughts: A one-sided discourse doesn’t benefit women
The decision to have a child is not one to be taken lightly, and there are plenty of good reasons a couple might determine that now is not the right time. It’s important that women and their partners know their options and the risks that come with each one, and that they can trust medical professionals to know them, too. Those painting a rosy picture of the mini-pill claim to be on the side of women, but rather than fostering honest dialogue about women’s health, they are sending the message that women aren’t worthy of important conversations concerning the nuances of birth control risks and benefits.
Undoubtedly, many women in the U.S. want easier access to birth control, celebrated Opill’s OTC approval, and look forward to other forms of hormonal contraception following suit. But the perceived benefits to some can’t justify obscuring the legitimate risk to many other women (and teenage girls, who can now purchase birth control with no oversight). When experts and media downplay potential threats to women’s health in the name of greater convenience and accessibility, it’s hard not to wonder where their true interests lie.
Additional Reading:
Opill is now available over-the-counter
References:
[1] Mørch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard Ø. Contemporary Hormonal Contraception and the Risk of Breast Cancer. N Engl J Med. 2017 Dec 7;377(23):2228-2239. doi: 10.1056/NEJMoa1700732. PMID: 29211679
[2] Fitzpatrick D, Pirie K, Reeves G, Green J, Beral V. Combined and progestagen-only hormonal contraceptives and breast cancer risk: A UK nested case-control study and meta-analysis. PLoS Med. 2023 Mar 21;20(3):e1004188. doi: 10.1371/journal.pmed.1004188. PMID: 36943819; PMCID: PMC10030023.
