The Opill (norgestrel) tablet was 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.

With today's approval, millions more Americans will now have access to a nonprescription daily oral contraceptive, according to Patrizia Cavazzoni, M.D., head of the FDA's Center for Drug Evaluation and Research. "When used as directed, daily oral contraception is safe and expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."

By enabling people to buy an oral contraceptive without first having to see a doctor, Opill's non-prescription availability may lower access obstacles. The 6.1 million pregnancies that occur in the United States annually are almost all unplanned. Unwanted pregnancies have been linked to unfavorable neonatal, developmental, and child health outcomes, as well as poor maternal and perinatal outcomes, including a decreased likelihood of obtaining early prenatal care and an increased risk of premature delivery. Opill, which is available over-the-counter, may aid in lowering the amount of unplanned pregnancies and their associated negative effects.

Norgestrel's effectiveness as a contraceptive was proven when it was first approved for prescription usage in 1973. Norgestrel was formerly available only by prescription; HRA Pharma submitted an application to change this. The FDA requires that the applicant show that the product may be used by consumers safely and effectively while relying solely on the nonprescription drug labeling and without the assistance of a healthcare provider in order for the FDA to approve the product for use in the nonprescription context. Studies revealed that, overall, consumer comprehension of the material on the Opill Drug Facts label was high and that a significant majority of consumers understood the label directions, supporting their capacity to use the medication as directed when it is sold over-the-counter. Opill is a safe and reliable drug when used as directed.

Opill effectiveness depends on consistent daily use at the same time of day. Opill should be taken at the same time each day. Utilizing drugs that interact with Opill may reduce the effectiveness of either Opill or the other drug, or both, and may even result in an unplanned pregnancy.

Regular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating are some of the most frequent adverse effects of Opill.

People who have or have ever had breast cancer shouldn't use Opill. Before using, patients with any other type of cancer should consult their doctor. Opill should not be combined with any other hormonal birth control method, including an intrauterine device (IUD), a vaginal ring, a contraceptive patch, an implant, an injection, or another oral contraceptive.

Use of Opill may result in altered vaginal bleeding patterns, such as sporadic bleeding and protracted spotting. Customers should tell their doctor if they experience frequent vaginal bleeding after intercourse, extended bleeding episodes, or amenorrhea (lack of menstruation). People who have missed two periods (or one period and missed doses of Opill) or who think they could be pregnant should get a pregnancy test. Customers should stop taking Opill if pregnancy is found to be present.

Opil does not prevent pregnancy after unprotected sex and is not intended for use as emergency contraception. HIV, AIDS, and other sexually transmitted diseases like chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis are not prevented by oral contraceptives. To avoid sexually transmitted infections, use condoms.

Laboratoire HRA Pharma, which Perrigo Company plc recently bought, received FDA approval.