The Opill (norgestrel) tablet is the first daily oral contraceptive approved for use in the United States without a prescription by the U.S. Food and Drug Administration today. After receiving approval, this progestin-only oral contraceptive pill will now be available to people without a prescription at drug stores, convenience stores, grocery stores, and online.
The manufacturer sets the price and release date for an over-the-counter medication. Only by prescription will further approved dosages and formulations of oral contraceptives continue to be made available.
“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 Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex. 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. Condoms should be used to prevent sexually transmitted diseases.
Opill should be taken at the same time every day; adherence to daily use at the same time of day is important for the effectiveness of Opill. 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.
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 another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).
Use of Opill may be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding. Consumers should inform a health care provider if they develop repeated vaginal bleeding after sex, or prolonged episodes of bleeding or amenorrhea (absence of menstrual period). Individuals 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. Consumers should discontinue Opill if pregnancy is confirmed.
The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc. The pills will be available in stores and online early in the first quarter of 2024.
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