Today, the U.S. Food and Drug Administration approved Opil (norgestrel) tablets for over-the-counter use to prevent pregnancy. It is the first daily oral contraceptive to be approved for over-the-counter use in the United States. This progestin-only oral contraceptive approval provides consumers with the option to purchase oral contraceptives at drug stores, convenience stores, grocery stores and online without a prescription.

The availability and price of this non-prescription product is determined by the manufacturer. Other approved oral contraceptive formulations and doses will continue to be available only by prescription.

“Today’s approval marks the first available option for millions of people in the United States for daily non-prescription oral contraceptives,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. ‘ said. “When used as directed, daily oral contraception is safe and hopefully more effective than currently available non-prescription contraceptive methods in preventing unwanted pregnancies.”

Opill’s non-prescription availability may reduce barriers to access by allowing individuals to obtain oral contraceptives without first seeing a health care provider. Almost half of the 6.1 million pregnancies in the United States each year are unwanted. Unwanted pregnancies are associated with negative maternal and perinatal outcomes, such as reduced likelihood of receiving early antenatal care and increased risk of preterm birth, and are associated with neonatal, developmental, and pediatric health outcomes. adversely affect. The availability of over-the-counter opils may reduce the number of unwanted pregnancies and their potential adverse effects.

Norgestrel’s contraceptive efficacy was established in 1973 when it was first approved for prescription use. HRA Pharma Application Switch norgestrel from prescription to over-the-counter product. To approve a product for use in a non-prescription environment, the FDA requires: Applicant demonstrates Consumers can safely and effectively use the product without the assistance of a medical professional, relying solely on the over-the-counter label. Studies show that overall consumer understanding of information on Opill Drug Facts labels is high, with a high percentage of consumers understanding label instructions and appropriately using medicines available as over-the-counter products. It is proven that it can be done. When used properly, Opil is safe and effective.

Opil should be taken at the same time each day. For Opill to be effective, it is important to use it at the same time each day. Using medications that interact with Opill can make Opill and/or other medications less effective and can lead to unintended pregnancies.

The most common side effects of Opil include irregular bleeding, headache, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating.

Opil should not be used by people who have or have had breast cancer. Consumers with other forms of cancer should consult a physician before use. Also, Opil should not be used with other hormonal contraceptives such as another oral contraceptive, vaginal ring, contraceptive patch, contraceptive implant, contraceptive injection, or IUD (intrauterine device).

Opil use may be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding. Consumers should inform their health care provider if they have recurrent vaginal bleeding after sexual activity, or if they have prolonged bleeding or amenorrhea (absence of menstrual periods). Anyone who has missed two periods (or missed one of her periods and missed an opil) or who may be pregnant should take a pregnancy test. If pregnancy is confirmed, the consumer should stop taking Opil.

Opil cannot be used as an emergency contraceptive and does not prevent pregnancy after unprotected intercourse. Oral contraceptives do not prevent infection with 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 infections.

The FDA has granted approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.

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