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FDA Approves Opill: First Over-the-Counter Birth Control Pill in the US

In a significant breakthrough, the FDA has given its stamp of approval to Opill, the first nonprescription birth control pill in the United States. Opill, a progestin-only pill containing the hormone progesterone, is now available for purchase over-the-counter.

Opill offers an effective means of preventing pregnancy when used correctly, and it is anticipated to be more reliable than currently accessible nonprescription contraceptive methods. This approval marks a momentous stride forward for women’s health, ensuring that birth control becomes more accessible, affordable, and capable of reducing the incidence of unintended pregnancies.

The FDA based its decision on data from a clinical trial, demonstrating Opill’s efficacy in preventing pregnancy when taken as directed. The trial also revealed Opill to be safe, with side effects comparable to other birth control pills.

It is important to note that Opill is not suitable for everyone. Women with a history of breast cancer should avoid taking it. Furthermore, to ensure effectiveness, Opill birth control pill must be taken at the same time every day.

While the FDA has yet to announce the specific availability date of Opill over-the-counter, Perrigo, the manufacturing company, has expressed its commitment to making the pill accessible and affordable.

Opill’s journey began in 1973 when it initially gained FDA approval under the brand name Ovrette as the first progestin-only pill in the United States. Originally available only by prescription, it transitioned to over-the-counter status in 1988. Unfortunately, due to declining sales, Opill birth control pill was discontinued in 2000.

In 2017, Perrigo, a pharmaceutical company, acquired the rights to Opill and embarked on re-launching it as an over-the-counter medication. In 2022, Perrigo submitted an application to the FDA for over-the-counter approval, culminating in the unanimous recommendation from an FDA advisory committee in May 2023. Finally, on July 1, 2023, the FDA granted its approval for Opill’s over-the-counter use.

How does Opill work? Opill prevents ovulation, the release of an egg from the ovary, while also thickening the cervical mucus to impede sperm from reaching the egg.

Opill boasts an efficacy rate of 91% when taken correctly, signifying that out of 100 women using Opill, approximately 9 may become pregnant within a year.

Opill birth control pill is not suitable for everyone. Pregnant women or those with a history of breast cancer, liver disease, or taking specific medications such as anticonvulsants should not take Opill. If you have any health concerns, it is vital to consult with your doctor before starting Opill.

To ensure effectiveness, Opill must be taken once a day at the same time every day.

The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, and cramps or bloating. Typically, these side effects are mild and temporary.

Opill is generally considered safe; however, it is advisable to discuss any health concerns with your doctor prior to usage.

Looking ahead, Opill is expected to be available over-the-counter in stores in the upcoming months. While the price has not been announced by Perrigo, the company remains committed to making the pill affordable.

The approval of Opill as an over-the-counter medication represents a tremendous stride towards achieving reproductive health equity. It ensures that all women, regardless of income or insurance status, have access to safe and effective birth control.

In summary, the FDA’s approval of Opill as an over-the-counter birth control pill is a significant victory for women’s health. It guarantees enhanced accessibility, affordability, and efficacy, ultimately contributing to the reduction of unintended pregnancies.

Sources:

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

https://edition.cnn.com/2023/07/13/health/fda-otc-birth-control-opill/index.html

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