For immediate release:

Today, the United States Food and Drug Administration approved Opill (norgestrel) tablet for use without a prescription to prevent pregnancy – the first daily oral contraceptive approved for use in the United States without a prescription. The approval of this progestin-only oral contraceptive pill offers consumers the ability to purchase oral contraceptives without a prescription at pharmacies, convenience stores, and grocery stores, as well as online.

The availability schedule and price of this over-the-counter product is determined by the manufacturer. Other approved formulations and strengths of other oral contraceptives will remain available by prescription only.

“Today’s approval marks the first time that a non-prescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and FDA Research. “When used as directed, daily oral contraception is safe and expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”

The availability of Opill over-the-counter can reduce barriers to access by allowing individuals to obtain an oral contraceptive without first seeing a health care provider. Nearly half of the 6.1 million pregnancies in the United States each year are unintended. Unintended pregnancies have been associated with negative maternal and perinatal outcomes, including a reduced likelihood of receiving early prenatal care and an increased risk of preterm birth, with adverse effects on neonatal, developmental, and infant health. The availability of Opill over the counter can help reduce the number of unwanted pregnancies and their potential negative impacts.

The contraceptive efficacy of norgestrel was established with initial authorization for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product intended for use without a prescription, the FDA requires that the the plaintiff demonstrates that the product can be used by consumers safely and effectively, relying solely on over-the-counter drug labeling without the assistance of a medical professional. Studies have shown that consumer understanding of Opill Drug Facts label information was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to use the drug correctly when it is available as an over-the-counter product. When used correctly, Opill is safe and effective.

Opill should be taken at the same time each day; compliance with daily use at the same time of day is important for the effectiveness of Opill. Using medicines that interact with Opill may cause Opill or the other medicine, or both, to work less effectively, possibly leading to an unwanted pregnancy.

The most common side effects of Opill include irregular bleeding, headache, dizziness, nausea, increased appetite, abdominal pain, cramping or bloating.

Opill should not be used by those who have or have ever had breast cancer. Consumers who have another form of cancer should consult a physician before use. Opill should also not be used with any other hormonal contraceptive such as another oral contraceptive tablet, vaginal ring, contraceptive patch, contraceptive implant, contraceptive injection or IUD (intrauterine device).

Use of Opill may be associated with changes in vaginal bleeding, such as irregular spotting and prolonged bleeding. Consumers should tell a health care provider if they develop repeated vaginal bleeding after sex, or prolonged episodes of bleeding or amenorrhea (missed periods). People who miss two periods (or who have missed a single period and have missed doses of Opill) or who think they are pregnant should take a pregnancy test. Consumers should discontinue Opill if pregnancy is confirmed.

Opill is not intended for use as emergency contraception and does not prevent pregnancy after unprotected sex. Oral contraceptives do not protect against the 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.

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

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.