GRAND RAPIDS, Mich. — Store shelves could soon be stocked with a contraceptive medication that's as easily obtainable as aspirin.
On Thursday, the U.S. Food and Drug Administration approved Opill, the country’s first daily oral birth control authorized for use without a prescription.
“Pregnancy is complicated. Our lives are complicated,” said Dr. Brad Irving, an OBGYN at University of Michigan Health-West. “I think... giving [people] the option that they could expand their family when they're ready for it is, I think, has been shown to be a benefit to our society.”
Opill is manufactured by Grand Rapids-based Perrigo.
Irving says the approval removes barriers to care like the time and money needed for a doctor’s appointment.
According to the FDA, almost half of the 6.1 million pregnancies in the U.S. each year are unintended. This has been linked to negative maternal and perinatal outcomes, but the agency believes Opill’s easy access may reduce those statistics.
“There's been a lot of strides made in trying to improve access, to improve coverage of contraception, to improve to make it easier to get reliable contraception, but it's still a problem,” said Irving. “The idea of having a pill that's reliable, safe and functional, over-the-counter that you can purchase on your own, I think should improve access.”
The progesterone-only pill got FDA approval decades ago, but Perrigo needed to meet additional consumer safety guidelines to sell it over the counter.
Irving says Opill boasts a 98 percent efficacy rate with perfect use or 93 percent with average use. It must be taken at the same time every day.
“I think that was one of the big things as far as the FDA approval is it demonstrated that this doesn't have as high of a thrombogenic potential or stroke potential as traditional birth control pills,” said Irving. “It doesn't have any association with any elevation of cancer risk.”
He does not recommend women with weight issues, liver disease or breast cancer take Opill. Common side effects include headaches, dizziness and nausea.
Opill should be available in early 2024, according to Perrigo. A price for the product has not been determined.
“If someone has more complicated medical problems, they certainly should probably consult with a physician, but for your average run of the mill, healthy person, I think this would be an option that can be used,” said Irving.
