What patients need to know

The primary over-the-counter (OTC) contraception tablet, Opill, will probably be obtainable at pharmacies, comfort shops, grocery shops and on the Opill.com web site later this month or early April.

The birth control pill is used to forestall being pregnant and will probably be obtainable with out a prescription.

Opill is made by the pharmaceutical firm Perrigo. A one-month provide prices $19.99, and a three-month provide prices $49.99, in keeping with Perrigo.

Drug maker says tablet will probably be reasonably priced and simple to get

The Meals and Drug Administration (FDA) introduced approval of Opill (norgestrel) final yr.

At a information briefing final July, Frederique Welgryn, Perrigo’s world vp for girls’s well being, mentioned the corporate is “dedicated to making sure that Opill is reasonably priced and accessible to individuals who want it.”

A study printed earlier this yr in JAMA Community Open discovered that in 2021, virtually half (45%) of individuals in search of reproductive well being care providers skilled at the very least one barrier to entry, and 19% skilled as much as three obstacles.

“Having over-the-counter entry to this progestin-only tablet will increase sufferers’ potential to acquire contraception that’s more practical than different OTC strategies like condoms or spermicides,” mentioned Melissa Chen, an affiliate professor within the UC Davis Division of Obstetrics and Gynecology. “This will probably be a handy choice, particularly for individuals who have problem getting clinic appointments or prescriptions and refills.”

In accordance with the nonprofit Free the Capsule, contraception capsules are already obtainable over-the-counter in additional than 100 international locations, together with Mexico and the UK. However within the U.S., contraception capsules have solely been obtainable by prescription since they have been first accepted in 1960. Norgestrel, the lively ingredient in Opill, was accepted for prescription use in 1973.

Drugs solely comprise one hormone

Progestin-only contraception capsules are typically generally known as POPs. The capsules comprise just one hormone, progestin, and are estrogen-free.

“Progestin-only capsules are safer in comparison with mixture contraception capsules that comprise each progestin and estrogen,” mentioned Chen. “Progestin-only capsules haven’t got the identical dangers of blood clots or stroke as mixture capsules.”

Mitchell Creinin is a professor within the UC Davis Division of Obstetrics and Gynecology and director of the Complicated Household Planning Fellowship program at UC Davis Well being. “Even with mixture capsules, critical problems are uncommon. And vital well being problems are extremely unlikely with POPs,” Creinin mentioned.

In accordance with the American School of Obstetricians and Gynecologists, progestin-only capsules like Opill assist stop being pregnant in some ways. The capsules make it tough for sperm to enter the uterus. Additionally they skinny the liner of the uterus and cease ovulation for many individuals who take it. To be efficient in stopping being pregnant, the capsules have to be taken on the identical time day-after-day.

The commonest unwanted effects of such capsules embody irregular bleeding, complications, dizziness, nausea, elevated urge for food, stomach ache, cramps or bloating. Different hormonal unwanted effects embody pimples and temper modifications.

Some individuals shouldn’t take Opill

Though individuals will be capable to buy Opill with out a go to to their physician, Chen cautions that some individuals shouldn’t take the medicine.

“Individuals who suspect they’re pregnant or have breast cancer or one other progestin-sensitive most cancers shouldn’t take it. The tablet is also much less efficient in people who find themselves taking sure drugs which have drug interactions with the tablet—equivalent to drugs for epilepsy or antibiotics for tuberculosis,” Chen mentioned.

Different drugs that may intervene with contraception capsules embody anti-HIV medicine, some antifungal medicine, and even some herbs, like St. John’s Wort.

Chen encourages sufferers to debate any drugs they’re taking with their medical doctors.

Stopping undesirable pregnancies

In its assertion final July, the FDA addressed the potential impact of Opill on unintended pregnancies.

“Nonprescription availability of Opill might cut back obstacles to entry by permitting people to acquire an oral contraceptive with out the necessity to first see a well being care supplier. Nearly half of the 6.1 million pregnancies within the U.S. every year are unintended. Unintended pregnancies have been linked to destructive maternal and perinatal outcomes, together with diminished probability of receiving early prenatal care and elevated threat of preterm supply, with related adversarial neonatal, developmental and little one well being outcomes. Availability of nonprescription Opill might assist cut back the variety of unintended pregnancies and their potential destructive impacts.”

For extra data, view the FDA announcement on its website.