FDA Approves Opill, the First Nonprescription Daily Oral Contraceptive in the U.S.
The U.S. Food and Drug Administration (FDA) has granted approval for Opill (norgestrel) tablet to be available without a prescription, making it the first daily oral contraceptive that can be purchased directly by consumers. This significant development provides individuals with the option to access oral contraceptive medicine conveniently at various retail locations, including drug stores, convenience stores, grocery stores, and online platforms.
Benefits of Nonprescription Availability
The nonprescription availability of Opill is expected to lower barriers to access, eliminating the need for individuals to consult healthcare providers before obtaining an oral contraceptive. With approximately 6.1 million unintended pregnancies occurring in the U.S. each year, this new option aims to reduce such occurrences and mitigate the associated negative maternal and perinatal outcomes. Unintended pregnancies have been linked to a decreased likelihood of early prenatal care and an increased risk of preterm delivery, which can lead to adverse neonatal, developmental, and child health outcomes.
Safety and Effectiveness of daily oral contraceptive
Opill’s contraceptive efficacy was initially established when it received prescription approval in 1973. HRA Pharma, the manufacturer, sought to switch Opill from prescription to over-the-counter status. To obtain approval for nonprescription use, the FDA requires the applicant to demonstrate that consumers can safely and effectively use the product based solely on the information provided in the nonprescription drug labeling, without assistance from a healthcare professional. Studies have shown that consumers have a high level of understanding of the information on the Opill Drug Facts label, indicating their ability to use the product correctly.
Proper Usage and Considerations of Opills
For Opill to be effective, it should be taken at the same time every day. Interactions with other medications can reduce Opill’s efficacy or that of the other medication, potentially resulting in unintended pregnancy. Common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating. It is important to note that Opill should not be used by individuals with a history of breast cancer or other forms of cancer. Additionally, Opill should not be used in conjunction with other hormonal birth control products such as oral contraceptives, vaginal rings, contraceptive patches, contraceptive implants, contraceptive injections, or intra-uterine devices (IUDs).
Monitoring and Awareness while taking Opills
Opill may cause changes in vaginal bleeding patterns, including irregular spotting and prolonged bleeding. Consumers should consult a healthcare provider if they experience repeated vaginal bleeding after sex or prolonged episodes of bleeding or amenorrhea. Those who miss two periods or suspect pregnancy after missing a single period and Opill doses should take a pregnancy test. If pregnancy is confirmed, Opill should be discontinued.
What are the Limitations and Additional Considerations while taking the Opills ?
Opill is not intended for use as emergency contraception and does not prevent pregnancy after unprotected sex. It is important to note that oral contraceptives do not protect against sexually transmitted diseases, including HIV, AIDS, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. To prevent the transmission of sexually transmitted diseases, the use of condoms is recommended in addition to Opill.
Approval Details of the Opills
The FDA granted approval to Laboratoire HRA Pharma, which was recently acquired by Perrigo Company plc.
The FDA’s approval of Opill as the first nonprescription daily oral contraceptive in the U.S. signifies a major milestone in reproductive health. By offering a safe and effective contraceptive option without the need for a prescription, Opill aims to empower individuals and contribute to the reduction of unintended pregnancies.