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The Food and Drug Administration has approved the birth control pill Opill, known generically as norgestrel, which will be available without a prescription starting Thursday. This is the first oral contraceptive to be dispensed without a prescription in the US.
“When used as directed, daily oral contraception is safe and expected to be more effective than currently available non-prescription methods of contraception in preventing unintended pregnancy,” Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research. release _
What exactly is Opill?
Opill is a type of hormonal birth control pill that prevents pregnancy mainly by thickening cervical mucus to prevent sperm from reaching the egg. It’s what’s known as a “mini-pill,” meaning it contains only a synthetic form of the hormone progesterone, unlike the more commonly prescribed combination birth control pills, which contain both progesterone and estrogen. The FDA approved Opill as a prescription drug in 1973, but in other countries, such as the UK, it is available without a prescription.
Now that Opill has been approved for non-prescription, how will it work?
Paul Blumenthal, a professor of obstetrics and gynecology at Stanford University, tells Yahoo Life that Opill will be available like any other over-the-counter drug. Opill will be available in convenience stores, pharmacies, supermarkets and online. The FDA stated that the price will be determined by Laboratoire HRA Pharma, owned by drug maker Opill Perrigo. Perrigo, the Associated Press reports, will try to make the pill available early next year.
“It would be similar to someone going to their local pharmacy and buying medicine like ibuprofen or Tylenol without a prescription,” Dr. Gopika Krishna, a family planning expert and fellow in obstetrics and gynecology at Columbia University, tells Yahoo Life.
Perrigo has not publicly disclosed how much Opill would cost without a prescription. Over-the-counter drugs tend to be cheaper than prescription drugs, even though they are not covered by insurance.
Why was it approved?
In order for the FDA to approve a drug to be available without a prescription, the drug applicant must demonstrate that “consumers can use the product safely and effectively, based solely on the OTC label, without the help of a health care professional.” health”. Studies conducted showed that consumers had a high understanding of Opill’s instructions, which require users to take the drug within the same three-hour window every day, as mini-pills are less forgiving of missed or late pills than regular pills. combined contraceptives.
However, FDA officials initially expressed concern that users may not recognize for themselves that certain conditions would make Opill inappropriate for them. Women with a history of breast cancer or undiagnosed abnormal vaginal bleeding, for example, should not take the drug.
The FDA was also concerned that Opill might be less effective in overweight women, citing studies on emergency contraception. On its website, Planned Parenthood says that emergency contraception like Plan B isn’t as effective if you weigh more than 165 pounds. But the American College of Obstetricians and Gynecologists practice guidelines state that “women with obesity can be offered all options for hormonal contraceptive methods with the assurance that the efficacy of hormonal contraceptives is not significantly affected by weight.”
What do parents need to know?
Blumenthal says it’s important for parents of teens to understand that Opill is safe and effective, “and we have more than 50 years of experience to prove it.”
“Preventing an unwanted pregnancy if you are a sexually active teen is a very important investment in achieving your life goals, and parents should recognize this even if they prefer their teen not to be sexually active,” she says.
Opill’s application was approved without age restrictions. Emergency contraceptives like Plan B, for example, initially had restrictions for children under 16, but those age limits were eventually removed.
“Multiple drug organizations, including the American College of Obstetricians and Gynecologists, have supported access to over-the-counter contraceptives without age restrictions,” says Krishna. “Adolescents can face significant barriers to accessing contraception, so it is important to support increasing access to contraception.”
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