FDA Approves First Over-the-Counter Birth Control Pill in US
WASHINGTON — The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription in the United States.
The agency’s approval of the over-the-counter medication this morning is a first, and is seen as significantly expanding the access women have to contraception.
The medication is called Opill, and according to its manufacturer, Dublin-based Perrigo, it will likely become available at drug stores, convenience stores and grocery stores, as well as online, in early 2024.
“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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a written statement.
“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,” Cavazzoni said.
In a press release, the FDA said the nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider.
Almost half of the 6.1 million pregnancies in the U.S. each year are unintended, and 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 agency said.
Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts, it added.
The contraceptive efficacy of the drug that comprises the medication — known as norgestrel — was established with the original approval for prescription use in 1973.
HRA Pharma, which was recently acquired by Perrigo, applied to switch norgestrel from a prescription to an over-the-counter product.
For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.
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 over-the-counter product.
Opill should be taken at the same time every day and adherence to daily use at the same time of day is important for the effectiveness of Opill, the FDA said. Using medications that interact with Opill can result in decreased efficacy of the drug 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.
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. Opill also should not be used together with another hormonal birth control product such as an oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD.
The agency also warned that Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex, and reminded consumers that oral contraceptives do not protect against transmission of HIV, AIDS and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.
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