This new assessment puts an end to the controversy raised two years ago by the results of two clinical studies. They claimed that the Norlevo morning-after pill was not very effective on women who weighed over 75 kilos and totally ineffective in women over 80 kg. As a result, the drug leaflet had been amended.
As part of a European arbitration, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) analyzed the effect of women’s weight on the efficacy of hormonal emergency contraception. In July 2014, this committee ruled that the risk-benefit ratio of emergency contraceptives remained favorable, regardless of the woman’s weight. Today the European Commission announces that it has followed the opinion of the CHMP.
“The European modifications will soon be implemented in the French Summary of Product Characteristics (SPC) of these specialties” specifies the National Agency for the Safety of Medicines and Health Products (ANSM) in its press release.
Emergency contraception: two types of treatment available in France
In poor or unprotected intercourse, a woman who does not use contraception and does not want a child can prevent the risk of pregnancy with the morning after pill.
In France, there are two types of emergency contraceptives available. Those that contain levonorgestrel alone, such as Noverlo. They are dispensed by pharmacists, middle school and high school nurses or in family planning and education centers without a medical prescription and are only effective 3 days (72 hours maximum) after intercourse.
And EllaOne which contains ulipristal. While it can be used 5 days (120 hours) after intercourse, it can only be obtained with a prescription.
“Hormonal emergency contraception must be administered as quickly as possible after unprotected or poorly protected intercourse and that recourse to this so-called“ catch-up ”method must remain exceptional, in particular because of the higher risk of failure than regular contraception »Recalls the ANSM.