NEW YORK.—Advisors to the Food and Drug Administration (FDA) have concluded that the benefits outweigh the risks of manufacturing hormonal birth control pill sold under the brand opil and manufactured by French company HRA Pharma which is available without a prescription.
and at FDA accepts its advisors’ non-binding recommendation, Opill will become the first and only contraceptive pill over the counter Since 1960, the year in which oral contraceptives began to be marketed in the United States. A final decision is expected by early August.
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After a two-day meeting, the 17-member FDA committee voted and unanimously decided that Opill would be safe to sell. no recipea measure also supported by most medical association, which includes the American College of Obstetricians and Gynecologists and the American Medical Association. In a 2022 survey, it was found that 77% of over 5,000 women were in favor of the idea of being able to receive counselling. birth control pill over the counter, and many said it would be more comfortable and practical You can buy it without a prescription.
pills that only contain Progestina They have been widely used in the United States since the first such pill was approved in 1973. Like other oral contraceptives, they require a prescription from a health professional or, in some states, a pharmacist.
The experts told in the meeting that the vote of the advisors is justified. He said that after about a year Supreme Court canceled that country’s decision roe contra wadeand therefore the constitutional right abortion, the need to expand contraceptive options became more pressing. Studies show that about half of all pregnancies in the United States each year are unintended.
Opill, manufactured by French company HRA Pharma, aims to be the first over-the-counter mini-pill.
“On the balance between risk and benefit, it was not easy for us to justify not taking this step,” Maria Coyle, chair of the committee and associate clinical professor at the Ohio University School of Pharmacy, told the meeting. The benefits are many; this is medicine super effective,
Coyle commented that “for most users, the risk of the drug itself is greatly reduced, and the risk of unintended pregnancy, although it exists, is less than with existing over-the-counter methods of contraception.”
How does the pill work?
Opill, also known as “minipill”, contains only progestin, a synthetic version of progesterone. It works primarily by thickening the mucus on the cervix, which makes it harder for sperm to enter the uterus, explained Katrina Herrana, MD, an obstetrician-gynecologist with the Family Planning Program at Cedars-Sinai Medical Center in Los Angeles. .
It is also designed to prevent ovulation, but it low dose progestin This implies that the pill doesn’t do it systemically, Herrana said. According to the American College of Obstetricians and Gynecologists, four out of ten women who take the mini-pill continue to ovulate.
Each box of Opill contains 28 pills and is known to be very effective at preventing pregnancy when taken every day, at about the same time, with no break between each box; Also, the failure rate is about 7% (comparable to combination birth control pills that contain both estrogen and progestin).
Research Shows Progestin-Only Pills Are More Effective Than Alternatives birth control which are available today without a prescription, such as condoms And this spermicides, which have a higher failure rate. Less effective than birth control pills intrauterine device and sterilization.
Herrana said that if a woman is sure that she is not pregnant, she can start taking this pill at any time during her menstrual cycle. The drug should begin preventing pregnancy within 48 hours after taking the first pill, she said, so back-up birth control may be needed within that time.
What are the side effects and associated risks?
opil has fewer side effects and a lower risk profile than other birth control options, especially combination pills, said Carolyn Westhoff, a professor of reproductive health at Columbia University, at the meeting.
The most common side effect is unpredictable bleeding throughout the cycle, which can be heavier than normal and rarely follows a pattern, Herrana said, “which can be quite burdensome for many people.”
The drug should start preventing pregnancy within 48 hours after taking the first pill – credit: @GETTY
Centers for Disease Control and Prevention (CDC, for its abbreviation in English) suggest that combined oral contraceptives are associated with an increased risk of heart disease, high blood pressure, and blood clots. In contrast, according to the CDC, mini-pills are not associated with many significant long-term risks.
research suggests that taking progestin pillsLike Opill, it can aggravate severe liver disease or breast cancer, so people who have these diseases should avoid it.
What will it cost?
HRA Pharma The price of the drug has not yet been announced, but Affordability This is going to be one of the biggest barriers to female consumers going forward, said Dana Singiser, co-founder of the Contraceptive Access Initiative, a nonprofit advocating for greater access to contraceptives.
“Clearly, for the reproductive health of the community, it is a huge priority to make sure that sale price There is affordability for female consumers, who generally have less access to healthcare,” said Singer.
The Patient Protection and Affordable Care Act requires drug companies to fully cover prescription contraceptives, and according to Singrisar, health care activists reproductive rights They expect this will include Opill, even if it is bought without a prescription. But for that to happen, he said, it would be necessary for the Department of Health and Human Services to order insurers to include opilAnd it’s hard to quantify how long that process will take.
However, people who have insurance and access to a pharmacy or doctor can get a prescription for the mini-pill so they don’t have to pay out of pocket.
How soon will it be available if the FDA approves it?
Singerser said the pill could be available almost immediately. It will only depend on how quickly HRA Pharma can get this product “on the shelves with an FDA approval label.”
In theory this boreal would be available by the end of summer. “in the hallway of Family planning From a pharmacy they should get a package of Opill right next to condoms and emergency contraceptives,” Singisar explained.