Opill is said to be the first oral contraceptive medicine to be approved for over-the-counter (OTC) use in the US that can be purchased at drug stores, convenience stores, grocery stores, and online, without needing a prescription
US FDA approves Perrigo’s OTC birth control pill. (Credit: Brett Jordan on Unsplash)
Ireland-domiciled pharmaceutical company Perrigo has received the US Food and Drug Administration (FDA) approval for its progestin-only daily oral contraceptive, Opill, for all ages.
Perrigo said that Opill is the first oral contraceptive medicine to be approved for over-the-counter (OTC) use in the US.
With the FDA approval, consumers can purchase the progestin-only oral contraceptive pill at drug stores, convenience stores, grocery stores, and online, without needing a prescription.
The scientific evidence shows that progestin-only pills such as Opill are effective at preventing pregnancy and are safe for most women to use, said the pharmaceutical company.
Perrigo president and CEO Patrick Lockwood-Taylor said: “Opill has the potential to radically transform women’s access to contraception and is a true testament to Perrigo’s unwavering commitment to deliver impactful solutions that truly make lives better.”
According to the US FDA, around 50% of pregnancies in the US, each year are unintended and have been linked to negative maternal and perinatal outcomes.
The availability of a non-prescription contraceptive may help reduce the number of unintended pregnancies and their potential negative impacts.
The approval of Opill as a non-prescription medicine may help individuals obtain an oral contraceptive without the need to first see a healthcare provider.
Opill is advised to be taken at the same time every day, as adherence to daily use at the same time of day is crucial for its effectiveness.
The most common side effects of the drug include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.
Perrigo women’s health global vice president Frederique Welgryn said: “Today’s approval is a groundbreaking expansion for women’s health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access.
“Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages.
“I want to thank the FDA and its advisory panels, the Free The Pill coalition, the numerous medical organizations and advocacy groups, and all those who wholeheartedly supported this enormous undertaking that has made today a giant leap for women’s empowerment.”