Perrigo, the producer, revealed on Monday that the first over-the-counter birth control pill “Opill” will be available on drugstore and store shelves nationwide, as well as online, later this month, for roughly $20 for a 30-day supply.
The medicine, Opill, is now available for pre-order from some online shops. It was authorized by the FDA for OTC use for all ages in July, making it the first daily birth control cleared for sale without a prescription in the United States.
Perrigo, the producer, revealed on Monday that the first over-the-counter birth control pill will be available on drugstore and store shelves nationwide, as well as online, later this month, for roughly $20 for a 30-day supply.
The medicine, Opill, is now available for pre-order from some online shops. It was authorized by the FDA for OTC use for all ages in July, making it the first daily birth control cleared for sale without a prescription in the United States.
According to Perrigo, the product will be available in a range of sizes, including one-month, three-month, and six-month packs for suggested retail prices of $19.99, $49.99, and $89.99, respectively.
The business expects to launch a cost-assistance program in the coming weeks to assist qualified low-income, uninsured persons in obtaining the medication at a low or no cost, according to the statement.
HRA Pharma, a Perrigo subsidiary, purchased the rights to Opill from Pfizer in 2014. The medicine was first licensed by the FDA in 1973 for prescription usage.
“Progestin-only pills have been a trusted contraceptive option for decades, yet obtaining a prescription for birth control pills creates unnecessary barriers for many,” said Dr. Melissa J. Kottke in a news release.
The business expects to launch a cost-assistance program in the coming weeks to assist qualified low-income, uninsured persons in obtaining the medication at a low or no cost, according to the statement.
HRA Pharma, a Perrigo subsidiary, purchased the rights to Opill from Pfizer in 2014. The medicine was first licensed by the FDA in 1973 for prescription usage.
“Progestin-only pills have been a trusted contraceptive option for decades, yet obtaining a prescription for birth control pills creates unnecessary barriers for many,” said Dr. Melissa J. Kottke in a news release.
“Creating more opportunities for contraceptive access is critical in helping people achieve their reproductive goals,” said the Atlanta-based obstetrician-gynecologist, who worked as a paid consultant for Perrigo throughout the FDA approval process.
According to the consumer products company, which is headquartered in Dublin, Ireland and Grand Rapids, Michigan, the medicine is 98% effective when taken exactly as advised.
The FDA reports that over half of the 6.1 million pregnancies in the United States each year are unplanned.
What is Opill ?
Opill, the first over-the-counter birth control pill in the United States.
Opill, the brand name for norgestrel, a progestin-only pill (POP), has a unique role in American birth control history. It’s the first and only FDA-approved oral contraceptive that doesn’t require a prescription, making it a practical and accessible choice for many women.
How Opill Works:
Opill’s effectiveness in preventing pregnancy stems from its multi-pronged approach:
- Thickening cervical mucus: This creates a barrier, making it difficult for sperm to reach the egg.
- Potential ovulation suppression: In some cycles, Opill may prevent the release of an egg from the ovary.
- Thinning the uterine lining: This reduces the chances of a fertilized egg successfully implanting.
When taken consistently at the same time each day, Opill boasts a 91% effectiveness rate. However, typical use effectiveness is around 83%, meaning about 17 out of 100 women using Opill will get pregnant each year.
Benefits of Choosing Opill:
- Convenience: No need for a doctor’s visit or prescription, making it readily available.
- Potential for higher effectiveness: Compared to other methods like spermicide or condoms (when used perfectly), Opill may offer a higher level of protection.
- Estrogen-free: This can be advantageous for women who have contraindications to estrogen or experience side effects from it.
First Over-The-Counter Birth Control Pill ‘Opill’ Side Effects:
While generally safe and well-tolerated, Opill can cause some side effects, including:
- Irregular bleeding patterns, spotting, or breakthrough bleeding
- Breast tenderness
- Headaches
- Nausea
- Dizziness
These side effects are usually mild and tend to subside within a few months of starting Opill. However, consulting a doctor is crucial if you experience any severe or persistent side effects.
Opill Cost
While the manufacturer’s suggested retail price for Opill sits around $20 for a one-month supply and $50 for a three-month supply, actual costs can vary. Checking with your pharmacy or retailer for the final price is crucial. Additionally, inquiring about insurance coverage can help lower your out-of-pocket costs.
Opill Manufacturer
HRA Pharma, a global pharmaceutical company headquartered in France, manufactures Opill. They specialize in women’s health products and have a long history of developing and marketing innovative solutions in this area.
Who Should Not Use Opill:
Opill is not suitable for everyone, particularly those with certain health conditions:
- Blood clots or a history of blood clots
- Uncontrolled high blood pressure
- Severe liver disease
- Undiagnosed abnormal vaginal bleeding
- Pregnancy or suspected pregnancy
If you have pre-existing health conditions or concerns, it’s vital to discuss Opill with your doctor to determine its suitability for you.
Who Should Not Use Opill:
Additional Considerations:
- Opill does not offer protection against sexually transmitted infections (STIs).
- It can interact with other medications, so informing your doctor about all your medications is crucial before starting Opill.
- Missing pills requires specific actions to ensure continued protection. Consult the instructions or your doctor for guidance.
In Conclusion:
Opill serves as a valuable addition to the birth control landscape, offering a convenient and potentially effective option for many women. However, it’s essential to remember that individual suitability is crucial. Discussing your options and any concerns with your doctor is always the best course of action for making informed decisions regarding your health and well-being.
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Source- FDA advisory panels takes action to make Opill birth control pill available over the counter
Who Manufactured Opill
Opill was manufactured by HRA Pharma, not Perrigo. Although Perrigo is involved in Opill’s tale, it is critical to distinguish their roles:
HRA Pharma, a French pharmaceutical firm that specializes in women’s health products, developed and manufactured Opill.
Perrigo business plc: In May 2023, this Irish business purchased HRA Pharma, taking control of Opill and other HRA medicines. However, Opill was not manufactured directly by Perrigo.
Therefore, while Perrigo today owns HRA Pharma and thus owns the rights to Opill, HRA Pharma remains the actual manufacturer of Opill.
Does Opill Contain Estrogen ?
Opill does not include estrogen. It is a progestin-only pill (POP), which means it solely contains the synthetic hormone norgestrel. This contrasts with many combined oral contraceptive tablets (COCs), which include both estrogen and progestin.
The absence of estrogen is a significant advantage for some people who are unable or unable to use estrogen-containing birth control techniques due to potential health risks or adverse effects.
How long does it take for Opill to work?
The pill takes 48 hours (2 days) to become effective in preventing pregnancy. This implies that for the first two days after taking your first pack of Opill, you must use a barrier method of birth control, such as condoms, every time you have sex.
When taken at the same time every day for 48 hours, Opill reaches its maximum effectiveness in preventing pregnancy. It’s crucial to remember that skipping medications might reduce their effectiveness, so adhering to the specified timetable is critical for best protection.
What is the failure rate of Opill?
Opill’s effectiveness in preventing pregnancy is measured using two important metrics:
Perfect use involves meticulously adhering to the directions and taking the tablet at the same time every day without missing any doses. Opill has a 91% efficacy rate, which means that with proper use, just 9 out of 100 women will become pregnant in a year.
Typical use: This accounts for real-world scenarios where people may skip tablets or take them at different times throughout the day. With average use, the efficiency of Opill reduces to roughly 83%, indicating that 17 out of every 100 women using it will become pregnant within a year.