The first contraceptive pill without a prescription in the United States will be on sale in pharmacies and on the internet at the end of March or beginning of April, after being approved in 2023 by the Food and Drug Administration (FDA), its manufacturer announced this Monday.
The pharmaceutical company Perrigo made the announcement about the opill pill in a statement where it recommends that it be sold at a cost of 19.99 dollars for a one-month supply, 49.99 for three months and 89.99 for half a year.
“The availability of an oral contraceptive without a prescription is a truly innovative milestone in reproductive health,” obstetrician-gynecologist Melissa J. Kottke explained in the document.
Perrigo also indicated that starting this week, interested people will be able to begin requesting pre-orders for the pill in certain stores.
“Progestin pills have been a reliable contraceptive option for decades, but getting a prescription for them created unnecessary barriers for many people,” Kottke added.
“Creating additional opportunities for access to contraceptives is critical to helping people achieve their reproductive goals,” she said.
Perrigo assured that Opill is 98% effective which, according to the statement, “makes it the most effective over-the-counter contraceptive method” on the market. “Almost half (45%) of the 6.1 million pregnancies that occur each year in the United States are unwanted (…) so Opill can benefit a large population of reproductive age “You want a safe option to avoid it.”
Perrigo Senior Vice President and Chief Commercial Officer Sara Young said the entire company is pleased “that so many retailers have decided to distribute Opill to help ensure access to the product across the country.”
Additionally, Young advised that “a cost assistance program will also be available in the coming weeks for assist qualified low-income and uninsured people to obtain Opill at low or no cost.”
How does the pill work?
Opill contains norgestrel, a synthetic form of the hormone progesterone that works in several ways to prevent pregnancy. First, it thickens the mucus of the cervix, making it difficult for sperm to enter the uterus and fertilize the egg. Second, it thins the lining of the uterus, making it less conducive to implantation of a fertilized egg. And third, it can prevent ovulation, or egg release, in most people.
Like many other progestin-only birth control pills, Opill must be taken at the same time every day to prevent pregnancy. Progestin must remain at a certain level in the body to effectively prevent pregnancy.
If a dose of Opill is taken even three hours late, or if you experience vomiting or diarrhea within four hours of taking the pill, you should avoid sexual intercourse or use a non-hormonal method of contraception for two days.
Although it only takes about two days for the drug to reach an effective level, sperm can remain fertile in the female reproductive tract for up to five days after intercourse, so it is important to take this medication regularly before and after unprotected sex.
However, it does not prevent sexually transmitted infections, so people who want to further protect themselves should use some type of barrier method during intercourse.
Before their approval in the United States, birth control pills were already sold without a prescription in more than 100 countries around the world. The same drug that Opill contains, norgestrel, has been used safely and effectively for birth control since 1973. It is sold by prescription under the brand name Ovrette.
Norgestrel has been shown to be safe for most women. However, it should not be used by those who suffer or have suffered from breast cancer, since some are sensitive to hormones and, in several cases, these cause greater growth of tumors.
Opill should also not be used by pregnant women or people taking certain medications for seizures, tuberculosis, HIV, AIDS, or pulmonary hypertension, as norgestrel may not be as effective when taken with these medications.
What are the side effects?
The most common include nausea, breast tenderness, increased appetite, acne, fatigue and headaches, similar to those with other hormonal contraceptive products. In most cases, side effects decrease over time.
Opill does not contain estrogen, like other hormonal contraceptives. Estrogen plays a role in menstrual regularity, so people using this pill may experience more irregular vaginal bleeding, bleed less, or stop bleeding while taking them.
A common safety concern about hormonal contraceptives is the risk of blood clots, such as deep vein thrombosis or pulmonary embolism. This risk is mainly associated with products that contain estrogen in addition to progestin.
Progestin-only pills, such as Opill, have little or no risk of clot formation. However, even those products that contain estrogen have a lower risk of blood clots than the risk during pregnancy or postpartum.
They demand more accessibility
Although reproductive health advocates embraced the news of the commercialization of Opilsin prescription, they also assured that there is still a long way to go before there is equitable and quality access throughout the country.
“One of the first priorities should be to improve the availability of other forms of the over-the-counter birth control pill (Opill contains only progesterone, while other pills containing estrogen and progesterone are still awaiting FDA approval). Another concern is where the pill will be stored and how much the medication will cost for people without insurance or other barriers,” Contraceptive Access Initiative (CAI) co-founder Dana Singiser told USA Today.
Likewise, Singiser considered that “the retail price will be out of reach for some people” and asked that the company not stay with large pharmacy chains and take into account “other types of markets, especially in rural areas.” .
