Yes, the Over-the-Counter Pill Is Safe

Pro-life OB/GYNs insist that an over-the-counter birth control puts women at risk of dangerous blood clots. Another doctor says they’re missing the point.


Editor’s Note: On June 16, The Daily Beast published a post on the contraceptive pill going over-the-counter (OTC) headlined “An Over-the-Counter-Pill Isn’t Safe.” The piece, which included a pro-life OB/GYN discussing the risks, sparked a huge reaction. Here is one doctor’s response.

An over-the-counter pill is safe.

The article stating the opposite left readers with three takeaways: 40 percent of women are at high risk for blood clotting, the pill can only be prescribed under the close guidance of a physician, and special screening may be required to safely take the pill.

These assertions could not be further from the truth.

While the American Congress of OB/GYN (ACOG) supports the safety of the oral contraceptive pill for OTC status (based on a vast body of scientific literature), this was mentioned only briefly. Instead, the medical arguments in the post rested primarily on the opinions of two people. The first an obstetrician/gynecologist named Dr. Poppy Daniels, who is a member of the American Association of ProLife OB/GYNs. Second, the author of the book Sweetening the PiIl, Holly Grigg-Spall, who has stated she wrote it in “a bid to spark a backlash against hormonal contraceptives.”

Clinical expertise and an individual’s experience are the lowest quality medical evidence. Doctors often rely on opinion and case reports when studies are unclear or don’t exist—and that’s certainly not the case with the pill, which is one of our most studied medications.

I have 25 years experience as a physician and 20 as a board-certified OB/GYN and for two years ran a contraception clinic for women at high risk of medical complications. However, it isn’t my clinical experience that I use to answer questions about pill safety in science.

An individual doctor sees tens of thousands of patients over a lifetime and often only for a window of time. Studies can look at millions of women from diverse settings much more representative of the general population and over many years. Large studies illuminate the whole pie; we doctors only see a very small slice. The other advantage of studies is that when done correctly they can control for bias.

ACOG supports an OTC move for the pill. This is not because of collusion with Big Pharma or a clandestine agenda to get women hooked on hormones. It’s because unplanned pregnancies are a major health issue in the United States and science supports an OTC move. Here are important facts that have been left out of the debate:

A doctor’s prescription doesn’t make the pill safer. Studies tell us that a physician asking about family history doesn’t identify women at increased risk for blood clots.

A pharmacist can effectively provide the screening needed. The only test that is needed is a blood pressure check.

When provided with information women can make the best—and safest—decision. The pill with estrogen isn’t appropriate medically for every woman, but by using a checklist women can determine accurately if they are medically eligible to take the pill or not.

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Women want it. Surveys tell us the majority of women favor an OTC move and many of those women are not currently using a highly effective method of birth control.

A prescription is a barrier for many women. OTC may help more women start and stay on contraception.

Blood tests to screen for clotting disorders before starting the pill are not indicated. The American College of Medical Genetics and Genomics (ACMG) says an association between abnormalities in the MTHFR gene and blood clotting (as advocated by Dr. Daniels) has been “disproven.”

The pill meets the FDA requirements for OTC status.

The pill is safer than a multitude of products already available OTC.

The main safety concern with the pill—the focus of the article—is blood clots, which are very serious. However, the absolute risk is low. When women are not on the pill that risk is 1-5 per 10,000 women per year. For those taking older pills the risk increases to approximately 3-9 per 10,000. Newer pills (which contain the hormone drospirenone and desogestrel) may raise the risk even more to 10-12 per 10,000.

Still, women are at much higher risk of clots during pregnancy and after delivery than they are with the pill. The risk of clotting during pregnancy is 5-20 per 10,000, skyrocketing to 40-65 per 10,000 in the first 12 weeks after delivery. Yet no one is required to get physician counseling before getting pregnant.

While getting the pill OTC might cause some women to miss out on in-depth contraceptive counseling about other even more effective methods (like IUDs), we don’t attach this counseling to condoms. Educational efforts about long acting reversible contraception should continue in parallel with the move to free the pill.

The birth control pill is a safe and effective way for many women to prevent pregnancy and science tells us that women can make their own health care choices. It’s time to take agendas out of contraception and free the pill.