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FDA green-lights first nonprescription daily oral contraceptive | iPharmaCenter

Opill (norgestrel) tablet will be available without a prescription for preventing pregnancy; it is now approved as an OTC product by the U.S. Food and Drug Administration (FDA). This marks the first time a daily oral contraceptive has been approved for nonprescription use in the United States. Consumers can purchase this progestin-only oral contraceptive at various retail locations, including drug stores, convenience stores, grocery stores, and online platforms.

The manufacturer will determine the availability and pricing of this nonprescription contraceptive. However, it's important to note that other approved formulations and dosages of oral contraceptives will continue to require a prescription. The introduction of nonprescription Opill could potentially break down barriers to access, allowing individuals to obtain oral contraceptives without having to visit a healthcare provider.

In the U.S., nearly 6.1 million pregnancies in each year are unintended, leading to negative maternal and perinatal outcomes. Nonprescription Opill's availability may help reduce unintended pregnancies and mitigate their potential negative impacts.

HRA Pharma, the company behind Opill, applied to switch norgestrel from prescription to over-the-counter status. The FDA requires that consumers use a product safely and effectively when considering nonprescription approval, relying solely on the information provided in the drug's labelling without any guidance from a healthcare professional. Studies demonstrated that consumers understood the information on the Opill Drug Facts label, supporting the notion that they can properly use the drug when available without a prescription. When used correctly, Opill is both safe and effective.

Opill should be taken at the same time every day to ensure effectiveness. Additionally, it's crucial to be aware that using medications that interact with Opill may decrease its efficacy, potentially leading to unintended pregnancy or reduced effectiveness of the other medication.

The common adverse events include irregular bleeding, headaches, dizziness, nausea, bloating, abdominal pain, increased appetite, and cramps. However, there are certain conditions where Opill should not be used, such as by individuals who have had breast cancer.

If a consumer misses two periods or suspects they may be pregnant after missing a single period and skipping Opill doses; they should take a pregnancy test. If pregnancy is confirmed, Opill should be discontinued.

It's important to note that Opill is not designed for use as emergency contraception and does not prevent pregnancy after unprotected sex.

Moreover, oral contraceptives do not protect from sexually transmitted diseases, including HIV and AIDS. To avoid sexually transmitted diseases, condoms should be used.

The FDA has approved Opill to Laboratoire HRA Pharma, which Perrigo Company plc recently acquired.

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