Over-the-Counter Birth Control, Now Approved

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This month, the FDA approved the first "Over-The-Counter" (OTC) birth control pill in history. FPA is proud to have contributed to the decision to dramatically expand contraception access, which makes it more convenient and affordable nationwide.

What is the Opill?

Opill is a Progestin-only pill containing 0.075mg of norgestrel. Because the Opill does not contain estrogen, it is safe for women with health problems such as uncontrolled hypertension, diabetes, history of a thombosis (clot in her veins), or even for women who smoke cigarettes.  

How Effective is the Opill?

With perfect use, norgestrel tablets are highly effective in preventing pregnancy. Based on the initial clinical trials of norgestrel tablets, the perfect-use effectiveness rate can be as high as 98%, meaning only 2 in 100 women will become pregnant in a year of use.

Perfect use includes taking one tablet every day, and at the same time each day without any breaks between monthly packs. It also includes always using backup birth control, like condoms, when the person misses or is delayed in taking the daily tablet for more than 3 hours. Perfect use is usually seen in clinical trials so "typical" use results in a lower efficacy, approximately 92%. 

FPA’s Contribution: The Opill Study

FPA Women's Health contributed to the data presented to the FDA supporting the safety and efficacy of Opill. The clinical team at FPA Women's Health enrolled adolescent patients (less than 16 years of age) from three of our offices and studied their ability to read the instructions on the package and take Opill correctly. 

We followed these patients for months and tracked any side effects, such as unscheduled bleeding. The study participants kept a diary of their pill use and the investigators tracked how often subjects missed a pill and if there were any contraceptive failures (pregnancy). 
At FPA Women's Health, we are proud to honor each person's autonomy to make the best choices for their own health and reproduction. For people who don't want to take a daily pill for contraception, FPA Women's Health will always be a source of skilled and knowledgeable clinicians who are available to place a longer-acting method. However, at a time in history when access to contraception is more crucial than ever, we are grateful the FDA has placed the ability to control fertility where it should be, in the pharmacy aisles and directly into the hands of every person at risk of unintended pregnancy.