Medical Professionals Reference (MPR)First Over-the-Counter Birth Control Pill Gets FDA Approval

Women of all ages will have easier access to an effective method of contraception with the removal of the prescription requirement.

In an unprecedented development, the FDA has given the green light to an over-the-counter daily oral contraceptive named Opill®, making it the first of its kind in the US.

Key Points:

• The FDA has approved Opill®, a daily oral contraceptive for over-the-counter use.
• The active ingredient in Opill® is norgestrel, a progestin, which acts by thickening cervical mucus to impede sperm penetration.
• Opill® is effective from 48 hours post-initiation, necessitating barrier method use during the first 2 days.
• Approval followed successful data from the OTC development program and a unanimous vote from two FDA advisory committees.

Additional Points:

• Opill® is contraindicated in known/suspected cases of breast cancer and pregnancy, and should not be used concurrently with other contraceptive methods.
• The common adverse reactions to Opill® include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating.
• Opill® tablets contain 0.075mg of norgestrel and will be available in retail and online stores in the first quarter of 2024.
• Leading medical organizations have expressed support for OTC access for oral hormonal contraceptives.

Conclusion:

• Opill® signifies a crucial step forward in contraceptive accessibility, providing a new non-prescription method to prevent unintended pregnancies.

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Did You Know?
According to the Guttmacher Institute, nearly half of all pregnancies in the United States are unintended, emphasizing the importance of accessible contraceptive options.