The European Medicines Agency has started a reassessment of the effectiveness of emergency contraceptives. Several scientific studies suggest a drop in efficiency in women over 70kg.
“Studies suggest that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing 80 kg or more” is the information that was revealed last November by the American site MotherJones.com. Two months ago, this site therefore indicated that the laboratory marketing this product had started to think about the need to modify its leaflet following the publication in 2011 of various studies showing that levonorgestrel-based contraceptives could be less effective in patients. women with a body mass index (BMI) elevated above 25. On Friday, the European Medicines Agency (EMA) released a statement stating that it had started a reassessment of the effectiveness of all emergency contraceptives containing levonorgestrel or ulipristal acetate, depending on the weight of users.
The Norlevo manual being modified
The EMA press release says it “will assess the impact of new data suggesting that a high weight could affect the effectiveness of emergency contraceptives. It will determine whether changes should be made to the wording of all emergency contraceptives containing levonorgestrel or ulipristal acetate ”. Following the publication of these studies in 2011 showing this reduction in the effectiveness of Norlevo, HRA Pharma, the French laboratory which markets it, analyzed its own clinical information and contacted the European health authorities in December 2012 to make the information available. on the updated packaging. Christian Jamin, gynecologist in Paris specified last November at Why actor that most of the studies which validated the effectiveness of Norlevo had been carried out in Asia where the build of women is not the same as in the West. The European Agency would have finally approved the change in the wording of Norlevo in early November. Christian Jamin also insisted on the fact that this loss of efficiency was, however, associated with weight and not with body mass index. In other words, this morning after pill would also be less effective in a tall woman, but who is not specifically overweight. The National Medicines Safety Agency (Ansm) also committed at the end of November 2013 to include in the leaflet of Norlevo and all its generics, before the end of the year, this information on the loss of efficacy in depending on the woman’s weight.
What about the other morning-after pills?
In its press release, the EMA notes that the change in the wording of Norlevo is not reflected in the wording of other emergency contraceptives containing the same molecule, namely levonorgestrel. This is one of the reasons that prompted the European agency to reassess the effectiveness of all emergency contraceptives containing them. In addition, another EllaOne morning-after pill containing ulipristal acetate, also marketed by the French laboratory HRA Pharma, will be included in this European assessment. The two studies published in 2011 in the journal Contraception also suggested a decrease in efficacy, but to a lesser extent, related to the weight of users. In November 2013, HRA Pharma also claimed to be reviewing this data.
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