First Over-the-Counter Birth Control Pill Approved by FDA
- by Natasha Hobley
- Published August 8, 2023
- Women
On July 13, 2023, the U.S. Food and Drug Administration (FDA) approved the first ever non-prescription birth control pill. The progestin-only oral contraceptive known as Opill (norgestrel) is expected to be available in pharmacies, supermarkets, and convenience stores by early 2024. Opill claims a 93 percent efficacy rate in pregnancy prevention.1
Norgestrel Originally Approved in 1970s, Pulled from Market in 2005
According to the FDA, over half of the 6.1 million pregnancies in the United States each year are unintended and providing an over-the-counter option will reduce barriers to care.2 This is not the first time this particular oral contraceptive has been manufactured and sold. Norgestrel was originally approved for prescription use in 1973 but was pulled off the market by the manufacturer in 2005. According to the Federal Register, the FDA determined that the tablet was withdrawn for business purposes and was not withdrawn from sales for reasons of safety or efficacy.3
The majority of oral contraceptives contain synthetic versions of both estrogen and progesterone. Opill is a progestin-only containing contraceptive. Progestin is the synthetic name for the hormone
progesterone. Other progestin-only containing contraceptives are often referred to as the “mini pill.”Known side effects of Opill and other progestin-only contraceptives include irregular menstrual cycles, ovarian cysts, ectopic pregnancy, hepatic neoplasia or liver disease, headaches, decreased glucose tolerance, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating. The manufacturer insert also states that the pill contains food dye FD&C Yellow No. 5, which may cause allergic reactions in certain individuals and is more frequently seen in patients with aspirin hypersensitivity.2
Opill was studied in adolescents as young as age 15, but will be available to all ages as an over-the-counter drug. While birth control is often prescribed to treat irregular or painful menstrual cycles, Opill is only approved for pregnancy prevention. Data for Opill included eight clinical studies in which 2.173 women completed one cycle and 648 women completed 13 cycles. The racial demographic for the studies were 53 percent Caucasian and 47 percent African-American, and age demographic studies was ages 15 to 49.3
Changes in Menstruation on Birth Control Deemed as Normal
When vital signs such as oxygen saturation, heart rate, or blood pressure experience major changes, most consider this as alarming and a symptom to explore. Yet this logic does not seem to extend to what some in the health industry call “the fifth vital sign—women’s menstrual cycles. According to Mayo Clinic, periods experienced on hormonal birth control are not actual periods but a withdrawal from the synthetic hormones.4
Many health care professionals and mainstream articles will claim that absence or changes in a period while on birth control is not a cause for concern. An article published by the U.S. National Institutes of Health (NIH) states:
The menstrual cycle—a complex process orchestrated by interactions between many of the body’s tissues, cells, and hormones—reflects a person’s overall health status and can be thought of as a “fifth vital sign,” along with blood pressure, body temperature, heart rate, and respiratory rate. Menstrual irregularities can indicate hormonal imbalances, gynecological diseases, or infections.5
Hormonal Contraceptives Deplete Critical Nutrients, Change Stress Response
Like other pharmaceutical products, the conversation about negative effects of birth control often occurs outside of mainstream medicine and are not a part of the informed consent process. One often unknown side effect of birth control is its tendency to deplete the body of several critical nutrients including B vitamins, vitamins C and E, selenium, magnesium, and zinc.6
Women taking oral contraceptives are also more likely to have elevated cortisol levels and even smaller hippocampal volume.7 Oral contraceptives effect on the composition of the gut microbiome is another area of health explored, but not often discussed by mainstream medicine.8
In an article discussing the pill’s effect on the stress response, psychologist Sarah Hill makes a valid point that we should all be considering, saying:
But just as we honor the spirit of democracy through the act of self-reflection and critical discussion, we need to continually push to get access to as much information as possible about this great emancipator of women. Women and women’s issues have almost completely been ignored for decades by medical research, which means that we know embarrassingly little research on the range of effects that the birth control pill can have on women’s bodies. And this particularly true when it comes to the impact of the pill on the brain and the stress response.9
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