Breaking barriers: FDA approves nonprescription daily oral contraceptive

More accessible birth control is finally here.

In a recent FDA approval, Opill (norgestrel) tablets are now over-the-counter to prevent pregnancy. It’s the first daily oral contraceptive approved in the US without a prescription.

Nonprescription birth control

The approval of this progestin-only pill gives consumers the option of buying oral contraceptives without a prescription at drug stores, convenience stores, grocery stores and online.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in an FDA news release [1].

By providing an oral contraceptive that is not prescription-required, Opill may reduce barriers to access. Almost half of the 6.1 million pregnancies in the US each year are unintended [2]. Opill may reduce unintended pregnancies and their negative effects if it’s available nonprescription.

A product that is approved for nonprescription use must demonstrate to the FDA that it can be used safely and effectively by consumers without any assistance from a healthcare professional, based only on nonprescription drug labeling [3].

Some guidelines, side effects and reminders

As with other birth control pills, Opill should be taken at the same time every day. It’s possible to get pregnant unintentionally when Opill interacts with other medications.

Regular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating are the most common side effects of Opill. People with breast cancer or those who have had it in the past should not use Opill. Ask a doctor before using if you have any other type of cancer.

Birth control and depression

It’s been discussed for years that contraceptives could negatively affect mental health and even lead to depression. It’s unclear why women stop taking contraceptive pills because of mood changes.

A recent study looked into this link [4]. More than a quarter of a million women were followed from birth to menopause by UK Biobank. Researchers collected information on women’s use of contraceptive pills, their first depression diagnosis, and their first depression symptoms without a diagnosis.

Get more insights about this research from the Cambridge University Press

Birth control and human lifespan

According to a study published in the British Medical Journal in 2010, women who have taken it can expect to live longer and have a lower risk of mortality from any cause, which includes cancer and heart disease. According to British researchers, their study provides reassuring news for millions of women worldwide who have used oral birth control pills [5]. The study found no evidence linking the use of these pills to an increased risk of premature death in the long run.

Per the study results, in the long run, women who took oral contraception had a lower rate of death from any cause, including heart disease and all types of cancer. However, the scientists noted that their findings may only apply to women who had taken older-style pills, as their study started in 1968 and did not include more modern types of drugs.

Despite the study showing a higher risk in women under 45 who are currently or recently taking the pill, the researchers said the risk disappears after ten years and the benefits outweigh the risks.

[1] https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
[2] https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states
[3] https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/017031Orig1s041SumR.pdf
[4] https://www.cambridge.org/core/journals/epidemiology-and-psychiatric-sciences/article/populationbased-cohort-study-of-oral-contraceptive-use-and-risk-of-depression/B3C611DD318D7DC536B4BD439343A5BD
[5] https://www.reuters.com/article/us-contraceptive-pill-risk-idUSTRE62B01R20100312

Photograph: seventyfourimages/Envato
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