comments_image Comments

What’s in a Label? Why the Package Insert for Plan B is Wrong… and Why It Matters.

Written by Kelly Cleland for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.
This article is published as part of our 2012 Back Up Your Birth Control series.
When you open up the box for your medication and unfold the package insert it all looks so... scientific. All of those chemistry diagrams, tables and warnings. You'd assume that labels for FDA-approved medications must be accurate and up-to-date, right? Think again. The labels for the emergency contraceptive pill Plan B One-Step and its generic cousins, Next Choice and Levonorgestrel Tablets, do not reflect the most current evidence about how the product works. The Plan B One-Step label says:
“Plan B One-Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium).”
This language was taken from the original Plan B label, approved in 1999, and reflects the understanding at the time of how Plan B might work. But the science has evolved considerably in the last 13 years. Newer evidence, published since the Plan B label was approved, provides compelling evidence that levonorgestrel EC (LNG EC) works before ovulation, but not after. Two recent studies tested whether there might be an effect of LNG EC on the implantation of a fertilized egg. Together with over a dozen other studies on how LNG works, we now have strong evidence it has no effect on the implantation of a fertilized egg. Continue reading....