OVER-THE-COUNTER BIRTH CONTROL PILL AVAILABLE SOON.

I think it’s surprising that oral contraceptives have not been available without a prescription before now. More than 100 countries have already made birth control pills OTC and with 63 years of patient use and experience to back it up, one would wonder why it hasn’t happened sooner. Well, there are several good reasons, and none of them have to do with moral judgements.  

Most birth control pills are a combination of estrogen and progesterone. There are, however, a few brands that contain only progesterone, and these are taken by the “small minority” of  women who have contraindications to taking estrogen. In the early years of birth control pills, the concentration of estrogen in the pill was quite high. That led to a number of serious, sometimes life-threatening, complications that frightened the public and medical professionals.  The most devastating of these was an elevated risk of stroke. I actually had a woman in her late 30’s who had a stroke, and the only explanation we could find was she was taking birth control pills. Partially responsible for strokes was the increased tendency for estrogen to cause blood to coagulate excessively so blood clots (deep vein and superficial thromboses) were one of the more common adverse events in women on BCP’s. Higher-estrogen BCP’s were also linked to increased risk for cervical cancer, liver tumors, and high blood pressure. Those women who had diabetes, obesity, elevated cholesterol, or a family history of heart disease had an increased risk of cardiovascular disease from estrogen-containing BCP’s.  

Since the 1990’s, the amount of estrogen in BCP’s has decreased significantly. The term often used was “the mini pill” — enough estrogen to suppress ovulation without causing blood clots, stroke, etc. These low dose combination pills have gained wide acceptance and serious complications are infrequent.

Having said this, the pill the FDA is considering for sale OTC is a progesterone-only pill! The reason for this, of course, is to avoid all the many adverse effects possible with estrogen pills I   mentioned previously. Indiscriminate, uncontrolled, unsupervised use of estrogen-progesterone BCP’s is perceived to lead to the adverse effects seen in past years. The FDA advisory committee voted 17-0 to start OTC oral contraceptive access with an effective, yet safe pill, every woman can take without being examined first. The trade name is “Opill.” It is manufactured by a company called Perrigo and contains 0.075 mg of norgestrel, one of the eight types of progestin found in BCP’s. It could be on pharmacy shelves by the end of this year or early next. Insurance doesn’t usually cover OTC medications so cost could be a factor in its acceptance. The World Health Organization touts independence, autonomy, and increased access that could be offset by higher out-of-pocket expenses. Politicians want birth control available for everyone at an affordable cost and this initiative could serve that desire.

Dr. G’s Opinion: One could moralize about OTC birth control pills forever, but this is something the American public wants. With unlimited access to Planned Parenthood, though, women seeking birth control have had an easy, readily accessible source of contraception for decades. Permitting distribution without an examination, as OTC access does, we may see increased rate of sexually transmitted infections or cervical dysplasia because screenings for those problems will be done far less frequently, if at all. And progestin-only pills have about a 2% higher failure rate than combination pills so there may be a few more unexpected pregnancies as well. 

My hope is that this decision will not lead to a deeper decline in societal mores, but noting where they already stand, that may not be an issue. 

References: Brown EJ, Deshmukh P, Antell K. Contraception Update: Oral Contraception FP Essent 2017 Nov;462:11-19.

Franklin M. Reassessment of the metabolic effects of oral contraceptives. J Nurse Midwifery 1990 Nov-Dec;35(6):358-364.

Rott H. Birth Control Pills and Thrombotic Risks: Differences of Contraception Methods with and without estrogen. Hamostaseologie 2019 Feb;39(1):42-48.

Rubin R Over-the-counter Birth Control Pill Could Be Available in the US by Year’s End JAMA 2023June 20;329(23):2009-2010.