A tale of two label changes

摘要

In November 2013, European authorities approved two significant changes to the label for NorLevo 1.5, an emergency contraceptive pill containing 1.5 mg levonorges-trel. The active ingredient in NorLevo 1.5 is identical to EC products available in the United States, such as Plan B One-Step and Next Choice One Dose. These changes are of compelling interest to reproductive health advocates and clinicians; the first is a new description of the product's mechanism of action, and the second is a warning that it may not work for heavier women. Although these changes were approved simultaneously, the evidence base for these two changes differs in substantial ways. We argue that the publicly-available evidence (in the form of peer-reviewed studies) around the mechanism of action of emergency contraception is sufficient to support this label change, while more evidence is desired to clarify the relationship between efficacy and weight.