In a pivotal advancement for reproductive health, the U.S. Food and Drug Administration (FDA) has given its approval for the sale of Opill (norgestrel) as a nonprescription medication intended to prevent pregnancy. This decision marks the first time a daily oral contraceptive can be purchased in the U.S. without a prescription.
The newly-approved progestin-only pill, available for purchase at pharmacies, convenience stores, grocery outlets, and online, offers consumers an accessible alternative to prescription oral contraceptives. The timeline and price for the nonprescription product will be set by the manufacturer, while other formulations and dosages of oral contraceptives will continue to be prescription-only.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, stated, “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
The over-the-counter availability of Opill could help overcome existing access barriers by eliminating the prerequisite of consulting a healthcare provider. Nearly half of the 6.1 million annual pregnancies in the U.S. are unintended, leading to negative maternal and perinatal outcomes including a decrease in early prenatal care and an increase in preterm delivery risks. These may result in negative neonatal, developmental, and child health outcomes. As such, Opill’s nonprescription availability could aid in reducing unintended pregnancies and their associated adverse impacts.
Norgestrel’s contraceptive efficacy was proven when it received initial prescription approval in 1973. HRA Pharma initiated the shift of norgestrel from a prescription to an over-the-counter product. The FDA’s approval for nonprescription products necessitates that applicants provide evidence that consumers can safely and effectively use the product, reliant solely on its nonprescription drug labeling, without any professional healthcare assistance. Studies affirming consumer comprehension of the Opill Drug Facts label and its instructions were high, verifying consumers’ potential to properly use the medication when made available as an over-the-counter product. When used correctly, Opill is both safe and efficacious.
Daily adherence to Opill is critical to its effectiveness, with the medication requiring administration at the same time each day. Concurrent use with other drugs may interfere with Opill’s effectiveness or that of the other medication, potentially leading to unintended pregnancy. The most frequently reported side effects of Opill encompass irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating.
Opill is not recommended for individuals who have been diagnosed with or have a history of breast cancer. Those with any other form of cancer are advised to consult a doctor prior to use. The use of Opill with other hormonal birth control products is discouraged.
Users may experience changes in vaginal bleeding patterns, including irregular spotting and prolonged bleeding. Health care providers should be notified of any persistent vaginal bleeding post-intercourse, prolonged episodes of bleeding or amenorrhea (absence of menstrual period). If two periods are missed (or one period is missed with previous missed doses of Opill), or pregnancy is suspected, users should conduct a pregnancy test and cease usage of Opill if pregnancy is confirmed.
Opill is not suitable for use as emergency contraception, nor does it offer protection against pregnancy following unprotected sex. It also does not safeguard against transmission of HIV, AIDS, or other sexually transmitted diseases. Concurrent condom usage is encouraged for protection against sexually transmitted diseases.
The approval for Opill was granted to Laboratoire HRA Pharma, which has been recently acquired by Perrigo Company plc.
Important Consumer information
When taking norgestrel nonprescription birth control tablets, it is very important to:
- Read the Drug Facts label and Consumer Information Leaflet before using the product, and re-read them every time you buy the product again.
- Take one tablet at the same time every day, even if you are having vaginal bleeding.
- Do not use the product if you have breast cancer, or ever had breast cancer in the past.
- Read the labeling about what to do if you miss a tablet.
- Talk to your health care provider if you have questions or concerns.
Background
On July 13, 2023, the FDA approved OPill as a nonprescription oral birth control pill.
Opill contains the hormone norgestrel and belongs to the class of medications known as progestins. Opill does not contain estrogen.
Questions and Answers
Q. Is norgestrel effective as a contraceptive?
The drug must be taken every single day and at the same time, or the effectiveness is reduced and pregnancy may occur.
With perfect use, norgestrel tablets are highly effective in preventing pregnancy. Based on the initial clinical trials of norgestrel tablets, the perfect-use effectiveness rate can be as high as 98%, meaning only 2 in 100 women will become pregnant in a year of use. Perfect use includes taking one tablet every day, and at the same time each day without any breaks between monthly packs. It also includes always using back-up birth control, like condoms, when the person misses or is delayed in taking the daily tablet for more than 3 hours. Perfect use is usually seen in clinical trials.
In real life, however, effectiveness of typical use of norgestrel tablets is lower than perfect use. Typical use takes into account human errors, such as forgetting to take the pill at the same time each day or not using a condom when the person misses a daily pill. The effectiveness of norgestrel tablet may be different for each person as some may find it difficult to use a product perfectly. In real world use, norgestrel is expected to be less effective than prescription norgestrel used in clinical trials that led to its initial approval. However, nonprescription norgestrel contraception is very likely to be more effective than other currently available nonprescription contraceptive methods.
When taking oral nonprescription norgestrel, it is important to read the full Drug Facts label and Consumer Information Leaflet before using it, and to re-read all the labeling every time you buy the product again.
Q. Can you use oral norgestrel for reasons other than preventing unwanted pregnancy?
Nonprescription norgestrel is not approved in the U.S. for uses other than the prevention of pregnancy.
Q. How was norgestrel available prior to the approval of nonprescription norgestrel?
Norgestrel was approved for prescription use in the U.S. for prevention of pregnancy in 1973 but has not been available since 2005 because of the manufacturer’s decision to stop selling the drug for business reasons.
Q. Does norgestrel lose its effectiveness in women who are overweight or obese?
In general, some studies have suggested that hormonal contraceptives (not just norgestrel) might have somewhat reduced effectiveness for women who are overweight compared to women who are not overweight. At this time, the available data are not clear regarding whether hormonal contraceptives will have a higher pregnancy rate when used by women who are overweight or obese.
If you have concerns about the potential for reduced effectiveness of oral contraceptives based on your weight, discuss your concerns with your healthcare provider. They can provide personalized advice and help you choose the most appropriate contraceptive method based on your individual circumstances.
Q. Are there any side effects of norgestrel?
Like any medication, norgestrel can have side effects. Common side effects may include irregular vaginal bleeding, nausea, breast tenderness, and headaches. These side effects are generally mild and often resolve on their own. However, if you experience severe or persistent side effects, it is important to seek medical advice.
Q. Who should not use norgestrel?
Norgestrel should not be used:
- If you have or ever had breast cancer
- If you are already pregnant or think you may be pregnant
- Together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device)
- As an emergency contraceptive (morning after pill)
- If you are male
Q. What medications or supplements can interact with norgestrel?
Ask a healthcare provider or pharmacist before using norgestrel tablets if you:
- are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, or pulmonary hypertension; or
- if you are taking a supplement containing St John’s Wort (an herbal ingredient).
Norgestrel may interact with these drugs, or they may make norgestrel less effective in preventing pregnancy. Norgestrel may also interact with ulipristal acetate (an emergency contraceptive, or morning after pill).
Q. Can norgestrel protect against sexually transmitted infections (STIs)?
No, norgestrel does not protect against STIs. It is solely a contraceptive method and does not provide any protection against infections such as HIV/AIDS or gonorrhea. To prevent STIs, it is important to use barrier methods such as condoms in addition to oral contraceptives.
Q. What should I do if I miss a dose of norgestrel?
If you miss a dose of norgestrel, or if you have vomited after taking norgestrel, read the label for further instructions. The recommended course of action may involve taking the missed pill as soon as possible and continuing with the remaining pills as scheduled. To ensure pregnancy prevention with a missed dose, you should use backup contraception, such as condoms, for 48 hours after the missed dose or after vomiting.
Q. Is norgestrel safe for everyone to use?
Norgestrel is generally safe for most people who could get pregnant. However, it should not be used for individuals with certain medical conditions, such as breast cancer, or those taking specific medications. If there are questions about whether Opill is right for you, consult with a healthcare professional who can evaluate your medical history and guide you on the most appropriate contraceptive method for your individual needs.
