European regulatory authorities to change emergency contraceptive labeling

Further analyses that build on data showing that the emergency contraceptive levonorgestrel is less effective in overweight women have prompted European regulatory authorities to revise the drug’s labeling, according to a statement from the manufacturer.

The new labeling for levonorgestrel (Norlevo, HRA Pharma) includes the following statement: “In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg.”

According to the statement, researchers first identified the effect of a woman’s weight on levonorgestrel’s efficacy while conducting a clinical trial in 2011 during the development of an alternative emergency contraceptive product. HRA Pharma then performed further analyses in 2012 and composed a safety variation to present to European regulatory authorities at the beginning of 2013.

Norlevo is the European equivalent to Plan B (Teva Pharmaceuticals), which is marketed as an emergency contraceptive option in the US. Whether the FDA will adopt a similar labeling change remains to be seen and HRA Pharma is not involved in the process.

For more information:

Glasier A. Contraception. 2011;84:363-367.