- Online orders are open for Opill, the first over-the-counter oral contraceptive in the U.S.
- Opill began shipping to major retailers and pharmacies on March 4.
- The FDA approved Opill in July 2023 amid ongoing battles for reproductive rights.
- Medical experts and organizations have been pushing for years for an OTC birth control pill.
Online orders for Opill, the first over-the-counter birth control pill in the United States, began rolling out on Monday.
The oral contraceptive is now available at Opill.com and Amazon. Opill also recently started shipping to major retailers and pharmacies nationwide on March 4.
“We champion the right of women and people to determine their own sexual health journey,” Triona Schmelter, executive vice president at Perrigo, the drug’s manufacturer, said in a recent news release.
Opill was approved by the Food and Drug Administration (FDA) in July 2023 to help make birth control more accessible and lower the risk of negative maternal and perinatal outcomes.
Each year, nearly half of the 6.1 million pregnancies in the U.S. are unintended. The FDA’s approval of Opill arrived alongside ongoing battles for reproductive rights.
“In the past two years, we’ve seen an increase in the numbers of states with bans on abortion, often without any real exceptions, even for life or health,” Dr. Sarah W. Prager, a professor in the Department of Obstetrics and Gynecology at the University of Washington School of Medicine, told Healthline.
“We are already seeing the negative impacts of these bans with increased pregnancy-related morbidity in states where abortion is now illegal. It is more important than ever for people to be able to prevent pregnancy unless or until they desire it, and access to contraception is critical for this.”
Opill (norgestrel) is a progestin-only daily oral contraceptive pill that will become available in the U.S. without a prescription. Progestin is a synthetic form of the hormone progesterone.
Opill will be sold online and in the family planning aisle at a number of retailers, including:
- drug stores
- convenience stores
- grocery stores
In addition, there will be no age restrictions on sales.
According to the FDA, norgestrel has been approved as an effective contraceptive for prescription use since 1973.
The FDA’s
Like many other oral contraceptives, Opill should be taken a the same time every day to ensure its effectiveness.
“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
Early clinical trials with norgestrel tablets have shown an effectiveness rate as high as 98%, according to the FDA, but only when the drug is used “perfectly” and with a backup birth control method, such as condoms if there is more than a three-hour delay in daily dosage.
Of course, in real life, “perfect use” may be more difficult compared to controlled settings like clinical trials.
In addition, Opill should not be used with other forms of hormonal birth control, such as a contraceptive patch, vaginal ring, or an IUD (intrauterine device), to ensure effectiveness and avoid contraindications.
The FDA notes that common side effects of Opill may include:
- irregular bleeding
- headaches
- dizziness
- nausea
- increased appetite
- abdominal pain
- cramps
- bloating
Consumers should always talk with their doctor about taking Opill with other medications.
People who have or have had breast cancer should not use Opill, and those living with other forms of cancer should speak with their doctor first.
When birth control is available over the counter, people do not have to see a doctor to obtain a contraceptive.
Making birth control more accessible could help lower the incidence of unintended pregnancies and related negative effects, disproportionately affecting individuals with low socioeconomic status and marginalized racial groups.
When pregnancies are unintended, millions of people cannot obtain the early prenatal care they need. Unintended pregnancies also increase the risk of negative maternal health outcomes, such as:
- preterm delivery
- adverse neonatal development
- adverse child health
Medical groups like the American College of Obstetricians and Gynecologists (ACOG) have been lobbying for over-the-counter access to hormonal contraceptives without age restrictions for years.
ACOG officials called the FDA approval of the OTC sale of progestin-only birth control a “critically important advancement” in making reproductive health care more accessible.
“ACOG has long supported OTC access to hormonal contraception, and we are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” ACOG officials said in a statement.
In a 2019 opinion letter on access to birth control, the ACOG wrote:
“Barriers to access are one reason for inconsistent or nonuse of contraception. The requirement for a prescription can be an obstacle for some contraceptive users. Several studies have demonstrated that women are capable of using self-screening tools to determine their eligibility for hormonal contraceptive use.”
Women’s health experts agree.
“Hormonal birth control, especially progestin-only birth control, has decades of data supporting its overall safety,” Prager said.
Prager noted
“I’m thrilled the FDA has approved an over-the-counter birth control pill, and this is an important step forward to provide better access to contraception for people,” Prager said. “This decision is very welcome, if long overdue.”
Opill, the first FDA-approved over-the-counter birth control medication in the U.S., is now available for sale online. The drug also recently began shipping to stores.
The drug is a progestin-only daily oral contraceptive pill that is effective when taken as directed. It will be sold in the family planning aisle at pharmacies, retailers, and online.
Making birth control available without a prescription could improve access for millions of people and prevent unintended pregnancies, which could help reduce the number of adverse maternal health outcomes.