The Food and Drug Administration’s advisers recently concluded that a birth control pill should be made available without a prescription. A final decision will be made in August, and there is still a chance that the FDA will not follow the recommendation of its advisers (it is non-binding recommendation), but that is unlikely. Since oral contraceptives were introduced in the US in 1960, no oral contraceptive has ever been available over the counter. Thus, if the FDA follows their advisers’ unanimous recommendation that the benefits outweigh the risks, a hormonal contraceptive pill sold under the brand name Opill would be the first oral contraceptive ever available without prescription.
The FDA advisors are not the only ones who believe Opill should be available over the counter. Medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, are also overwhelming in favor of making Opill available. Additionally, a 2022 survey that included over 5,000 female participants, discovered that 77 percent favored the idea of getting the birth control pill over the counter. Many believe it would be more convenient and efficient to get it without a prescription.
Given that the Supreme Court overturned the constitutional right to an abortion, the FDA advisers’ vote is timely. Studies have shown that about half of all pregnancies in the United States are unintended, so the need to expand contraceptive options has become more urgent. The committee chairwoman, Dr Maria Coyle, concluded that “In the balance between benefit and risk, we have a hard time justifying not taking action.” She went on to say, “the benefits are large, the drug is incredibly effective.” She also added, “the risk of the medication itself is incredibly low for the vast majority of users, and the risk of unintended pregnancy, while real, is less than that of existing over the counter measures of birth control.”
So how does Opill work? Opill (also known as “mini pill”) is a progestin-only drug. Progestin is a synthetic version of progesterone and works mainly by thickening mucus in the cervix to make it more difficult for sperm to enter the uterus. It also prevents ovulation in some women, but about 40% of women on Opill continue to ovulate. The mini pill is a daily pill and each box contains 28 pills. If taken every day at the same time, it is effective at preventing pregnancy, starting 48 hours after taking the first pill. The failure rate in actual users is about seven percent. Other over the counter options like condoms and spermicides have worse failure rates in actual users (as opposed to theoretical failure rates, derived from research). Intrauterine devices are more effective than birth control pills and have few side effects in most users. Besides their additional benefit of decreasing heavy menstrual blood loss, they are also much safer than in earlier decades - and they last for 5-7 years.
So, is Opill safe? Opill has fewer side effects than other birth control options. The most common side effect is unscheduled bleeding throughout the menstrual cycle that is heavier than spotting and may not follow any pattern. While safe, this can be frustrating – and as a side note, MANY women already have low iron reserves. While overt ‘anemia’ may be ruled out by standard lab tests such as a CBC, it turns out that even heavy-ish regular menstrual blood loss cannot keep pace with the usual modern diet - which tends to be low in iron-rich foods such as organ meats and dark greens. Fatigue, hair thinning, restless legs and even hunger may result from having frequent, heavy-ish menses with a resultant low Ferritin (under a level of about 50). Opill is not associated with many long-term risks though some research has shown that Opill might exacerbate severe liver disease or breast cancer if it’s already present - so women with either of those conditions should avoid it.
The moment the FDA approves Opill, it would become available almost overnight. However, it is still unclear how much Opill will cost, because insurance companies are not required to cover over the counter contraceptives. If you have any questions about Opill or any other contraceptive options, including insertion or removal of IUD’s (intrauterine devices), please schedule a visit and come see one of the experienced providers at Southwest Family Physicians.