Perrigo Company, plc, announced that the product would be available in-store and online from retailers nationwide in the coming weeks. Preorders from select retailers began in early March.
In July 2023, the pill was approved by the U.S. FDA for OTC use.
In announcing the approval of the Opill for nonprescription use to prevent pregnancy, the FDA said, “Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.”
The FDA said that other approved formulations and dosages of other oral contraceptives will remain available by prescription only.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said last summer. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
The FDA suggested that nonprescription availability of Opill might reduce barriers to access by allowing women to obtain an oral contraceptive without the need to first see a healthcare provider.
A press release noted that nearly half of the 6.1 million pregnancies in the U.S. each year are unintended. “Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes,” the FDA said. “Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.”
The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973, according to the agency.
HRA Pharma applied to switch norgestrel from a prescription to an OTC product. To do that, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a healthcare professional.
The FDA reported that studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an OTC product, adding, “When properly used, Opill is safe and effective.”
Opill should be taken at the same time every day, according to the approval, which emphasized that adherence to daily use at the same time of day is important for the effectiveness of Opill. It also cautioned that using medications that interact with Opill can result in decreased efficacy of Opill or the other medication, or both, potentially resulting in unintended pregnancy.
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating.
The FDA warns that Opill should not be used by those who have or have ever had breast cancer. “Consumers who have any other form of cancer should ask a doctor before use,” the FDA pointed out. “Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).”
The agency also advised that the use of Opill might be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding. Users are urged to inform a healthcare provider if they develop repeated vaginal bleeding after sex or prolonged episodes of bleeding or amenorrhea. Those who miss two periods (or have missed a single period and have missed doses of Opill) or suspect they may be pregnant should take a pregnancy test and then discontinue Opill if pregnancy is confirmed.
The FDA underscored that Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex. In addition, it said, oral contraceptives do not protect against transmission of HIV, AIDS, and other sexually transmitted diseases (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis), adding that condoms should be used to prevent sexually transmitted diseases.
The FDA granted the approval to Laboratoire HRA Pharma, which was recently acquired by Perrigo Company, plc.
Perrigo said consumers will have the opportunity to purchase Opill in a variety of sizes in stores, including 1-month and 3-month packs, with a manufacturer’s suggested retail price of $19.99 and $49.99, respectively. Additionally, Opill will be available for purchase at www.Opill.com at a price of $49.99 for a 3-month supply and $89.99 for a 6-month supply, the company advised.
“The availability of an oral contraceptive without a prescription is a truly groundbreaking milestone in reproductive health,” said Melissa J. Kottke, MD, MPH, MBA, an Atlanta obstetrician-gynecologist who was quoted in the Perrigo press release. “Progestin-only pills have been a trusted contraceptive option for decades, yet obtaining a prescription for birth control pills creates unnecessary barriers for many. Creating additional opportunities for contraceptive access is critical in helping people reach their reproductive goals.”
When taken as directed, Opill is 98% effective, according to the manufacturer, “making it the most effective birth control method available OTC.”
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