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FDA Advisors Support OTC Availability of Opill Birth Control Pill

Written and medically reviewed by Dorcas Morak, Pharm.D

Updated on May 25th, 2023

Save up to 88% on your medications

Written and medically reviewed by Dorcas Morak, PharmD

Exciting news! On May 10, 2023, advisers to the Food and Drug Administration (FDA) unanimously recommended that Opill, a birth control pill, should be made available without a prescription. The two advisory panels voted 17-0 in favor of switching Opill to over-the-counter status, despite concerns about the supporting data. While the FDA is not obligated to follow the committee's recommendation, it is expected to heavily consider it. We anticipate the FDA's final decision in late summer. If approved, Opill, manufactured by HRA Pharma, would become the first over-the-counter birth control pill in the United States.

What is Opill?

Opill a contraceptive pill containing 0.075mg of norgestrel, which is a progestin-only active steroid ingredient. Scientific evidence has shown that progestin-only pills like Opill effectively prevent pregnancy and are generally safe for most women. Opill works by suppressing ovulation, thickening cervical mucus to impede sperm movement, and thinning the lining of the uterus.

Contraindications of Opill

Before you consider purchasing Opill over the counter, there are some important things to keep in mind. There are certain contraindications that you should be aware of. It is not recommended to use Opill if you have had breast cancer in the past or currently have it, if you are currently pregnant or planning to become pregnant, if you are already using another form of birth control such as a birth control pill, vaginal ring, patch, implant, injection, or intra-uterine device (IUD), or if you are in need of emergency contraception (morning-after pill). Please note that Opill is not effective in preventing pregnancy when taken after unprotected intercourse.

Opill Dosing Recommendations

Opill is taken as a single tablet daily at a consistent time. You can start taking Opill on any day of your menstrual cycle. However, it's important to remember that it takes 48 hours (2 days) for Opill to become effective. Therefore, during the first two days of using your initial pack of Opill, make sure to use condoms or another form of barrier contraception every time you engage in sexual activity.

Side Effects of Opill

Like any medication, Opill may cause some common side effects such as headache, nausea, dizziness, acne, and back pain. Additionally, there are some potential side effects specific to Opill, including delayed follicular atresia/ovarian cysts, which could be accompanied by mild abdominal discomfort, and menstrual irregularities such as irregular periods, bleeding or spotting between periods, or complete cessation of menstruation. It's important to continue taking Opill tablets daily, even if you experience any changes in your menstrual cycle. However, if you experience recurring vaginal bleeding after sexual intercourse, heavy bleeding, periods that extend beyond eight days, or if your migraine headaches worsen or are accompanied by visual disturbances (aura), it is recommended to consult your doctor while maintaining your daily pill intake.

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What happens if I miss a dose?

Don't worry. Simply take the missed dose as soon as you remember and continue taking your daily medication at your usual time. Remember to use a condom or another barrier method every time you engage in sexual activity for the next 48 hours.

Possible Drug Interactions

It's important to be aware of possible drug interactions with Opill. Make sure to inform your healthcare provider about all your medicines, including prescription and over-the-counter vitamins and herbal supplements. Some examples of medications that may interact with Opill are:

It's always better to be safe and consult your healthcare provider if you have any concerns about potential interactions.

Making Opill More Affordable

We understand that affordability is a concern for many individuals, which is why we want to let you know about financial assistance options. If you need help affording Opill or any other contraception medication, download the RxLess app or visit rxless.com. Search for the medication you need, save your coupon (print, text to your phone, or open in the app), then show it at the pharmacy to save instantly.

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