The Food and Drug Administration (FDA), a US agency similar to Anvisa, approved this Thursday (13) the contraceptive pill Opill to be available without a prescription – the first contraceptive drug “over the counter” in the US.
“Today’s approval marks the first time that an over-the-counter daily oral contraceptive will be an available option for millions of people in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available over-the-counter contraceptive methods in preventing unwanted pregnancy,” he added.
Opill is a “mini-pill” that uses only the hormone progesterone.
Its manufacturer, Perrigo, called the FDA’s action a “landmark” and a “giant leap for women’s empowerment” in a statement.
He said the company is committed to making the pill “accessible and affordable for women and people of all ages.”
“Today’s approval is a groundbreaking expansion for women’s health in the US and a significant milestone in addressing an unmet need for contraceptive access,” he said. Frederick Welgryn Perrigo’s Global Vice President of Women’s Health.
It is unclear when Opill will be available in stores. The FDA says it’s up to Perrigo to determine the drug’s timing and price.
The agency has faced pressure to allow Opill to be sold over-the-counter from lawmakers and healthcare providers alike.
In a statement Thursday, the agency addressed increasing reproductive access for women and adolescents.
“The over-the-counter availability of Opill can reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to consult a healthcare professional first. Nearly half of the 6.1 million pregnancies in the US each year are unintended.”
“Unintended pregnancies have been associated with negative maternal and perinatal outcomes, including reduced likelihood of receiving early antenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental, and child health outcomes. The availability of Opill without a prescription may help reduce the number of unintended pregnancies and their potential negative impacts,” the FDA said in the statement.
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A recent study showed that it has become more difficult for women to access reproductive health services more widely – such as routine checkups and birth control – in recent years.
About 45% of women faced at least one barrier to reproductive health services in 2021, a 10% increase from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.
A group of FDA advisors recommended in May that Opill be approved for over-the-counter use.
The medication must be taken at the same time each day to be effective. The pill should not be taken by anyone who has, or has had, breast cancer, warns the FDA.
Some side effects commonly experienced while using Opill are “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramping or bloating,” according to the agency.
Source: CNN Brasil
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