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Talking about OTC EC’s new label

What providers need to know about the December 2022 updates to levonorgestrel emergency contraception (LNG-EC) labeling.

by Nicole Cieri-Hutcherson, PharmD, BCPS, NCMP

published 08/14/23

In December 2022, the FDA updated the mechanism of action on the LNG-EC (Plan B One-Step) Drug Facts label and Consumer Information Leaflet packaged with over-the-counter (OTC) EC. The 11 generic LNG-EC brands currently available will also have updated labeling. Here are answers to some of the most common questions I am hearing as a pharmacist about this update:

What’s the science behind the update?

The science is clear on how EC pills work to prevent pregnancy—stopping or delaying the release of an egg from the ovary, with little to no effect after ovulation. That means EC prevents pregnancy from starting in the first place and works in the same way as other birth control methods (yes, EC is birth control). EC also will not work if someone is already pregnant and will not affect an existing pregnancy, this means it cannot cause an abortion, and it doesn’t change someone’s chances of getting pregnant again in the future (even the next day). Check out this article with more on how to answer the most frequently asked questions]() about the difference between medication abortion and EC pills.

Why update the label now?

While the science is clear on how EC pills work, the previous labeling for Plan B One-Step suggested it could potentially disrupt an established pregnancy. The old label has caused a lot of confusion, even for providers. With increasing threats to birth control access and a gap in knowledge about the science of EC, updating the label is important to clearly state that Plan B One-Step works like other birth control methods to prevent pregnancy and cannot cause an abortion.

Did anything change with the medication?

Nope. It’s the same EC that’s been there all along, just with a new Drug Facts label and Consumer Information Leaflet.

Did anything else change on the label?

No, nothing else changed on the label. But, the wording in the Consumer Information Leaflet that accompanies the medication was also changed to remove any references to a mechanism of action unsupported by science. This means that all the language that PlanB One-Step impacts fertilization and implantation were removed. Both the Drug Facts label and the Consumer Information Leaflet kept statements that read, “PlanB One-Step will not work if you are already pregnancy and will not affect an existing pregnancy.”

Nicole Cieri-Hutcherson (she/her) is a clinical pharmacist specializing in internal medicine and reproductive health. She practices in acute care at Buffalo General Medical Center and is a clinical assistant professor at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences in Buffalo, NY. Her passion is reproductive health, specifically contraceptive care, menopause management, and drug selection during pregnancy and lactation. At home, she’s mom to 4 beautiful kiddos and enjoys photography and baking.
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