What patients need to know

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

The contraception tablet is used to stop being pregnant and shall be out there with no 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 accordance with Perrigo.

Drug maker says tablet shall be inexpensive and straightforward to get

The Meals and Drug Administration (FDA) introduced approval of Opill (norgestrel) final 12 months.

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 inexpensive and accessible to individuals who want it.”

A examine revealed earlier this 12 months in JAMA Community Open discovered that in 2021, nearly half (45%) of individuals searching for reproductive well being care providers skilled a minimum of 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’ means to acquire contraception that’s simpler than different OTC strategies like condoms or spermicides,” mentioned Melissa Chen, an affiliate professor within the UC Davis Division of Obstetrics and Gynecology. “This shall be a handy possibility, particularly for individuals who have problem getting clinic appointments or prescriptions and refills.”

In keeping with the nonprofit Free the Capsule, contraception drugs are already out there over-the-counter in additional than 100 nations, together with Mexico and the UK. However within the U.S., contraception drugs have solely been out there by prescription since they had been first authorised in 1960. Norgestrel, the lively ingredient in Opill, was authorised for prescription use in 1973.

Tablets solely include one hormone

Progestin-only contraception drugs are generally often known as POPs. The drugs include just one hormone, progestin, and are estrogen-free.

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

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

In keeping with the American School of Obstetricians and Gynecologists, progestin-only drugs like Opill assist forestall being pregnant in some ways. The drugs make it troublesome 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 drugs should be taken on the identical time daily.

The most typical unwanted side effects of such drugs embody irregular bleeding, complications, dizziness, nausea, elevated urge for food, stomach ache, cramps or bloating. Different hormonal unwanted side effects embody zits and temper adjustments.

Some folks shouldn’t take Opill

Though folks will be capable of buy Opill with no go to to their physician, Chen cautions that some folks shouldn’t take the remedy.

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

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

Chen encourages sufferers to debate any medicines they’re taking with their docs.

Stopping undesirable pregnancies

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

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

For extra info, view the FDA announcement on its web site.