Opill, First OTC Contraceptive Pill, Gains FDA Approval

The progestin-only contraceptive pill will be available without a prescription online and at retailers nationwide.

On July 13, the FDA approved nonprescription Opill (0.075mg Oral Norgestrel Tablet) — the first over-the-counter oral contraceptive approved by the agency.

Obtaining Opill will not require visiting a healthcare provider for a prescription, making it a new birth control option for millions who experience difficulties accessing healthcare. However, other oral contraceptive options will remain prescription only.

Opill's manufacturer, Laboratoire HRA Pharma — recently acquired by Perrigo Company — will determine when the over-the-counter birth control pill will be available to consumers and how much it will cost. However, CNN reports Opill is expected to be available on store shelves in March 2024.

"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," says Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research. "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."

Each year about three million individuals experience unintended pregnancies in the United States. Moreover, the FDA says unintended pregnancies have been linked to adverse maternal and child health outcomes. Therefore, the availability of a nonprescription oral birth control option like Opill may help reduce the number of unintended pregnancies and their potential negative impacts.

Norgestrel was first approved for prescription-only use in the U.S. in 1973. However, the manufacturer discontinued the drug in 2005 due to business reasons.

Recently, HRA Pharma applied for a Prescription-to-Nonprescription (RX-to-OTC) switch in the hopes the FDA would allow consumers to purchase Opill over the counter.

To approve the switch, the FDA requires the manufacturer to show that the product can be used by consumers safely and effectively by information provided on the drug's label without the assistance of a healthcare provider.

According to the FDA, studies demonstrated that overall, consumer understanding of the information provided on the Opill Drug Facts label was high and that many consumers understood the instructions. This indicated that individuals could use the medication properly if sold over the counter.

What is Opill?

Opill does not contain estrogen. Instead, the active ingredient in the medication is the hormone norgestrel which belongs to the class of drugs known as progestins. The pill is intended for pregnancy prevention and is not an emergency contraceptive. Moreover, it does not prevent sexually transmitted infections such as HIV, chlamydia, or genital herpes.

With perfect use, Opill is 98% effective at preventing pregnancy. However, individuals using Opill should take the medication at the same time each day, as even a three-hour delay can impair the drug's effectiveness. In addition, to reduce the chance of unintended pregnancy, people should not take Opill with medications that could interact with the drug.

Moreover, people who currently have or have had breast cancer should not use Opill, and individuals should avoid taking the medication with other hormonal birth control products such as oral, patch, injected, or implanted contraceptives, vaginal rings, or hormone-containing IUDs.

Side effects of the new nonprescription birth control pill may include irregular bleeding, headaches, nausea, dizziness, increased appetite, cramps, abdominal pain, or bloating.

However, because Opill may change vaginal bleeding patterns, people who use the medication should consult a health care provider if they develop frequent vaginal bleeding after sex, have prolonged bleeding episodes, or don't get their menstrual period for an extended time.

The FDA recommends that if a person has questions about taking Opill or wonders if it's appropriate for them, they should consider talking with a healthcare professional for guidance on which birth control option is right for them.

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