The U.S. Food and Drug Administration (FDA) has approved Opill, a non-prescription oral contraceptive tablet, for preventing pregnancy. This is the first daily oral contraceptive that can be purchased without a prescription in the United States. Opill will be available for sale at drug stores, convenience stores, grocery stores, and online, but the availability and price will be determined by the manufacturer. Other oral contraceptives will still require a prescription.
The approval of Opill as a non-prescription contraceptive option aims to provide easier access to birth control and reduce unintended pregnancies. Currently, almost half of the 6.1 million pregnancies in the U.S. each year are unintended, leading to negative maternal and perinatal outcomes. By making oral contraceptives available without a prescription, it is hoped that the number of unintended pregnancies and their associated negative impacts can be reduced.
The contraceptive efficacy of norgestrel, the active ingredient in Opill, has been established since its original approval for prescription use in 1973. To switch it from a prescription to an over-the-counter product, HRA Pharma submitted an application to the FDA, which requires demonstrating that the product can be used safely and effectively by consumers without assistance from a healthcare professional. Studies have shown that consumers have a good understanding of the information on the Opill drug labeling, supporting its safe and proper use.
Opill should be taken at the same time every day for maximum effectiveness. It is important to note that medications that interact with Opill can decrease its efficacy or the efficacy of other medications, 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.
There are certain conditions in which Opill should not be used, such as breast cancer or any other form of cancer. Consumers should also avoid using Opill together with other hormonal birth control products, such as oral contraceptive tablets, vaginal rings, contraceptive patches, contraceptive implants, contraceptive injections, or intra-uterine devices (IUDs). Changes in vaginal bleeding patterns, such as irregular spotting or prolonged bleeding, can occur while using Opill. Consumers should inform a healthcare provider if they experience repeated vaginal bleeding after sex, prolonged episodes of bleeding, or the absence of a menstrual period.
It is important to note that Opill is not intended for use as emergency contraception and does not prevent pregnancy after unprotected sex. It also does not protect against sexually transmitted diseases such as HIV/AIDS, chlamydia, genital herpes, gonorrhea, hepatitis B, and syphilis. Condoms should be used to prevent the transmission of these diseases.
The FDA granted approval for Opill to Laboratoire HRA Pharma, which was recently acquired by Perrigo Company plc. The FDA is an agency within the U.S. Department of Health and Human Services and is responsible for assuring the safety, effectiveness, and security of drugs, vaccines, medical devices, food supply, cosmetics, dietary supplements, and tobacco products.
