FDA Approves First Over-the-Counter Birth Control Pill in US

July 13, 2023 by Dan McCue
FDA Approves First Over-the-Counter Birth Control Pill in US
(Perrigo Company photo)

WASHINGTON — The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription in the United States. 

The agency’s approval of the over-the-counter medication this morning is a first, and is seen as significantly expanding the access women have to contraception.

The medication is called Opill, and according to its manufacturer, Dublin-based Perrigo, it will likely become available at drug stores, convenience stores and grocery stores, as well as online, in early 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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a written statement. 

“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,” Cavazzoni said.

In a press release, the FDA said the nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. 

Almost half of the 6.1 million pregnancies in the U.S. each year are unintended, and unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery with associated adverse neonatal, developmental and child health outcomes, the agency said.

Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts, it added.

The contraceptive efficacy of the drug that comprises the medication — known as norgestrel — was established with the original approval for prescription use in 1973. 

HRA Pharma, which was recently acquired by Perrigo, applied to switch norgestrel from a prescription to an over-the-counter product. 

For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional. 

Studies showed that consumer understanding of information on the Opill drug facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product.

Opill should be taken at the same time every day and adherence to daily use at the same time of day is important for the effectiveness of Opill, the FDA said. Using medications that interact with Opill can result in decreased efficacy of the drug or the other medication, or both, potentially resulting in unintended pregnancy. 

The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. 

Opill should not be used by those who have or have ever had breast cancer. Consumers who have any other form of cancer should ask a doctor before use. Opill also should not be used together with another hormonal birth control product such as an oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD.

The agency also warned that Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex, and reminded consumers that oral contraceptives do not protect against transmission of HIV, AIDS and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

A+
a-
  • birth control
  • FDA
  • Opill
  • over-the-counter
  • In The News

    Health

    Voting

    Health

    Majority of Americans Favor Forgiving Medical Debt, AP-NORC Poll Finds

    NEW YORK (AP) — Janille Williams wants to buy a house someday — but first, he has to pay down... Read More

    NEW YORK (AP) — Janille Williams wants to buy a house someday — but first, he has to pay down tens of thousands of dollars in medical debt. “I was hospitalized for a blood infection for three months more than ten years ago, and the bill... Read More

    Oversight Hearing on Illegal E-Cigarettes Highlights Dire Need for Reform of the FDA

    The Senate deserves credit for holding a recent hearing that underscored the failure of the U.S. Food and Drug Administration’s Center for... Read More

    The Senate deserves credit for holding a recent hearing that underscored the failure of the U.S. Food and Drug Administration’s Center for Tobacco Products to provide clear and fair regulatory pathways for smoke-free tobacco products that provide Americans with less harmful alternatives to combustible cigarettes. This hearing follows... Read More

    June 17, 2024
    by Anna Claire Miller
    Biden Campaign Redoubling Effort to Keep Abortion Rights Front of Mind for Voters

    WASHINGTON — With the second anniversary of the U.S. Supreme Court decision overturning Roe v. Wade fast approaching, the Biden-Harris... Read More

    WASHINGTON — With the second anniversary of the U.S. Supreme Court decision overturning Roe v. Wade fast approaching, the Biden-Harris campaign is organizing volunteers to share what they’ve experienced since that ruling went into effect. Decided on June 24, 2022, Dobbs v. Jackson Women's Health Organization... Read More

    Drug Shortages Keep on Growing. Older, Injectable Medicines Among the Most Vulnerable

    Erin Fox has tracked drug shortages for more than 20 years, and she sees no easy solutions for what has... Read More

    Erin Fox has tracked drug shortages for more than 20 years, and she sees no easy solutions for what has become a record run. Total active shortages hit an all-time high of 323 in this year’s first quarter, according to the University of Utah Drug Information... Read More

    Surgeon General Asks Congress to Require Warning Labels for Social Media, Like Those on Cigarettes

    The U.S. surgeon general has called on Congress to require warning labels on social media platforms similar to those now mandatory... Read More

    The U.S. surgeon general has called on Congress to require warning labels on social media platforms similar to those now mandatory on cigarette boxes. In a Monday opinion piece in the The New York Times, Dr. Vivek Murthy said that social media is a contributing factor in... Read More

    June 17, 2024
    by Jesse Zucker
    How the Ocean Improves Mental and Physical Health

    WASHINGTON — June 20 marks the first day of summer, and there’s nothing like a day by the ocean to... Read More

    WASHINGTON — June 20 marks the first day of summer, and there’s nothing like a day by the ocean to ring it in. In the spirit of the changing season, we’ll discuss how being near or in the ocean can improve mental and physical health. The... Read More

    News From The Well
    scroll top