Because the active drugs present in this version of emergency contraception are identical to Plan B One-Step and its generic varieties sold here in the U.S., this revision is extremely important.
After research from the University of Edinburgh suggested that levonorgestrel — the pregnancy-preventing drug in both Norlevo and Plan B One-Step — was prone to fail in women with higher BMIs, HRA Pharma petitioned the EU to allow them to update the packaging information.
The average American woman weighs 166.2 pounds, which is just over the threshold where these drugs begin to lose effectiveness. Because of legal structures around pharmaceutical packaging here in the U.S., the brand-name manufacturer (in this case, Teva Pharmaceuticals), must petition the FDA to change information before generic manufacturers can do so.
Teva had no comment when we asked whether they would change the information on their Plan B One-Step packages to mirror Norlevo's. It's frightening to think that so many women have been relying on a method of birth control that might not even be effective. Here's hoping this information gets out to all the women affected. (Mother Jones)