You are currently viewing FDA Approves Opill: First OTC Contraceptive Pill in the US

FDA Approves Opill: First OTC Contraceptive Pill in the US

July 18, 2023 | By Kali Girl

According to NBC, the Food and Drug Administration (FDA), granted approval for Opill, an oral contraceptive, to be sold over the counter, marking a significant milestone. Opill is the first hormonal contraceptive pill to be available without a prescription in the United States.

This decision is a triumph for medical associations such as the American Medical Association and the American College of Obstetricians and Gynecologists, who have long advocated for an OTC birth control pill.

Furthermore, this development arises amidst ongoing legal disputes concerning women’s reproductive rights.

“This is a monumental decision,” said Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University. “OTC birth control is available in over 100 countries, so we’ve been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy.”

Opill, commonly referred to as the “mini-pill,” received widespread recognition for its singular hormone composition, progestin, and daily dosage regimen. Initially sanctioned by the FDA as a prescription medication back in 1973, this contraceptive option is now set to break new ground with its over-the-counter (OTC) availability.

Extending its usage to individuals of reproductive age, including teenagers, nearly half of the 6.1 million pregnancies occurring annually in the United States are classified as unintended.

“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release.

Opill, demonstrated a remarkable effectiveness of 93% in preventing pregnancy during typical use, placing it on par with prescription oral contraceptives. For maximum results, the contraceptive must be taken at the exact same time each day.

Failure to adhere to this timeframe by more than three hours prompts experts to recommend utilizing a backup method, such as a condom, for the subsequent two days. If users fall outside of the three-hour window, experts strongly recommend employing a backup method, such as a condom, for the subsequent two days to ensure optimum protection.

According to the FDA, Opill will soon grace the shelves of drug stores, convenience stores, grocery stores, and even online platforms. However, those looking to purchase the product from physical stores must exercise a bit of patience. Perrigo’s HRA Pharma have indicated that Opill won’t hit the shelves until “early 2024.”

Leave a Reply