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First Over-the-Counter Birth Control Pill Approved by FDA

birth control pill

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 According to the Federal Register, the FDA determined that the tablet was withdrawn for business purposes and was not withdrawn from sales for reasons of safety or efficacy.3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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Click here to view References:

1 Belluck P. FDA approves first US over-the-counter birth control pill. The New York Times July 13, 2023.
2 News Release. FDA approved first nonprescription daily oral contraceptive. U.S. Food and Drug Administration July 13, 2023.
3 Federal Register. Determination that Ovrette (Norgestrel) tablet, 0.075 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. Oct. 25, 2017.
4 Mayo Clinic Staff. Delaying your period with hormonal birth control. Mayo Clinic Dec. 2, 2022.
5 Directors Corner. Menstrual cycles as a fifth vital sign. U.S. National Institutes of Health Sept. 13, 2021.
6 Palmery M et al. Oral contraceptives and changes in nutritional requirements. Eur Rev Med Pharmacol Sci July 2013; 17(13): 1804-13.
7 Hertel J et al. Evidence for Stress-like Alterations in the HPA-Axis in Women Taking Oral Contraceptives. Sci Rep Oct 26, 2017; 7(1): 14111.
8 Revenue of the artificial sweeteners market worldwide from 2018 to 2028. Statista Mihajlovic J et al. Combined hormonal contraceptives are associated with minor changes in composition and diversity in gut microbiota of healthy women. Environ Microbiol June 2021; 23(6): 3037-3047.
9 Hill S. Does the pill affect my stress response? Sarah E. Hill Evolutionary Psychologist Sept. 18, 2020.

One Response

  1. We do not know embarrassingly little, except if one buys into the decades of falsified misleading research on these matters. Some side effects not mentioned which is applicable to every type of chemical birth control; Irreparable harm passed down to the children, a compounding disassociation of a human beings ability to effectively regulate hormones, traits which they may still express long after consuming these substances, and even if they stop taking these substances, effects which will inevitably pass down to and be expressed to their offspring.

    Catholic doctors shouted these warnings at the time of the very first approvals of chemical birth control available to the public, that the real dangers would be how the reactions and imbalances which occur will eventually harm entire generations of children. Nobody listened. Frogs, newts, and other amphibians which spontaneously change sexes after exposure to synthetic substances are not the only casualty in the war to produce and sell more chemicals. Society today has not changed due to time, social influences, religious preference, or general changes which occur due to privilege and liberty. Not even close. Society today is changing due to chemical alterations induced by the substances we consume. ‘Let me explain this real slowly for you; I don’t like them putting chemicals in the water which turn the frigging frogs gay.’ Bold statements from visionaries of our day which shall go down in history as important warnings not heeded.

    Thankfully the flow of free information has continued and we can now rest assured more people understand the harms of chemicals like Astrazine and glyphosate. However, human being women continue to willingly consume a different chemical set which creates somewhat similar, and much more complex disruptions to human offspring development. A substance set with far more profound and longer reaching side effects. aka; birth control pills.

    Ladies, just get a no hormone insert and be done with birth control for the next five to seven years. Replace the device periodically through your life or simply have it removed if you seek pregnancy. No chemicals were ever necessary in the pursuit of the now entirely inaccurate and wrongly described pursuit of ‘womens health’. Talk to me about ‘science’? These people are not experts. This is not science.

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