“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frederique Welgryn, HRA’s chief strategy officer, when the company announced the application for over-the-counter use.
If Opill is approved for over-the-counter use, it would join emergency contraceptives, like Plan B, on pharmacy shelves.
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Advocates push for birth control pills without prescription
Reproductive rights organizations and leading medical associations have supported making birth control available without a prescription in order to overcome existing barriers to access and reduce the number of unwanted pregnancies.
The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians support making birth control pills available over-the-counter.
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“Women’s needs are nuanced, and it’s about time their health options reflect that,” Frederique Welgryn, global vice president for women’s health at Perrigo, said in a statement.
Contraceptive pills are available without prescription across much of the globe, including South America, Asia and Africa. Last year, a birth control pill was made available without prescription for the first time in the United Kingdom.
How does birth control pill Opill work?
Opill uses the synthetic hormone progestin to block sperm from the cervix, preventing pregnancy. Most other birth control pills use progestin and estrogen, and progestin-only pills like Opill are often recommended for people who can’t take combination pills due to health reasons.
HRA Pharma is seeking to convince the FDA that women can safely screen themselves for conditions that raise the risk of rare, but dangerous, blood clots when using birth control pills. But estrogen, not progestin, accounts for most of the blood clot risk associated with oral contraceptives.
Still, for most women, the drugs are safe with only three to nine suffering blood clots out of every 10,000 women taking combination pills annually, according to FDA data. That compares with one to five women suffering blood clots among 10,000 women who aren’t taking birth control.
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Dig Deeper
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