Over-the-Counter Birth Control Pills Are Not Free of Serious Side Effects and Complications

Oral contraceptives are medicine. They are hormones, a varying composition of estrogen and/or progesterone. My patients and I are big believers in them — not just for birth control, for which they are extremely effective, but also as a way to regularize the menstrual cycle.

In May, an advisory panel composed of 17 experts — including obstetricians, gynecologists and adolescent medicine specialists — voted unanimously for the approval of the birth control pill, Opill, for over-the-counter usage, and now the entire FDA has agreed.

So, who am I to disagree — especially as I believe in a woman’s right to contraceptives and I believe that birth control pills are safe when used correctly? I also believe that this move will improve access, especially for those who lack the insurance coverage or ability to readily access their gynecologist.

In fact, I have played that role myself, renewing oral contraceptive prescriptions for women who were waiting to get an appointment to see their gynecologist.

But over-the-counter availability is a whole different ballgame.

I have a problem with many over-the-counter medications — including aspirin, cold medicines, antihistamines and even laxatives. All of these commonly used medications have side effects, and all are frequently used by my patients without my awareness. 

Did you know that regular aspirin carries a significant risk of bleeding — including gastro-intestinal and brain bleeds — and that many who are taking aspirin are doing so outside of public health guidance for their age or condition and, perhaps more importantly, without a doctor’s guidance? Did you know that cold medicines can cause heart problems or drug interactions that frequently occur without a patient’s doctor being aware?

Opill contains the hormone norgestrel, a progestin, and completely lacks estrogen, which is not to say that it lacks all side effects. In fact, although it’s the combination birth control pills that have been most associated with blood clots, high doses of progestins can sometimes cause them — but even then, it’s true, the risk is very rare. Nevertheless, Opill has been associated with other side effects, including vaginal bleeding, nausea, breast tenderness, and headaches. According to the FDA, this drug should not be used in patients with a history of breast cancer or in combination with other birth control pills. It can also interact with seizure drugs, drugs for tuberculosis and HIV/AIDS, and rendered less effective at preventing pregnancy.

Hence, the concern which I and other doctors share about this drug joining the many over-the-counter drugs being taken without our patients consulting us or otherwise fully learning the potential risks, especially in combination with other drugs or health conditions.

There is no free lunch when it comes to medications, and once a drug is made available over the counter, there is no turning back.

There is a lot to be said for ready access to a birth control pill in terms of availability and cost savings, and over-the-counter contraceptives will certainly prevent thousands — if not millions — of unwanted pregnancies. At the same time, many significant side effects will likely go undetected or unmonitored. Not only that, but many patients will choose this birth control method because of easier access when another method might have been more effective for them or better tolerated.

I would have preferred a different approach: Require all birth control methods — including pills — to be covered by all insurances, including Medicaid, but make them subject to prescription by a physician or nurse practitioner. I can see both sides of this, but I still flinch whenever another active chemical is added to the pharmacy shelves next to the vitamins or sunscreen.

Medicine should guide these decisions, rather than politics. It is possible to be pro-contraceptive but still have serious reservations about over-the-counter use.

Dr. Marc Siegel, clinical professor of medicine at New York University’s Langone Medical Center, is the author of numerous books, including “COVID: The Politics of Fear and the Power of Science.” He hosts and is medical director of SiriusXM’s “Doctor Radio” program.