Brussels, 29/01/2013 (Agence Europe) - On 28 January, the European Medicines Agency (EMA) announced that it had been asked by France to review third- and fourth-generation combined oral contraceptives, “to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives”. The EMA stated that this is the first time a member state has approached it to call on it to issue Europe-wide recommendations on this kind of medicine within the framework of the new pharmacovigilance legislation introduced last year. In a press release, the EMA acknowledged that combined contraceptives carry a “very rare” risk of venous thromboembolism (VTE or blood clots). The absolute risk is very small (between 20 and 40 cases per 100,000 women in one year of use).
On 11 January, France announced that it was asking the EMA to review third- and fourth-generation combined oral contraceptives and highlight that second-generation oral contraceptives present less of a risk. The European agency, however, dismissed the demand, explaining that so far there had been “no new proof” from a European Union member state about the risk of blood clots provoked by these pills (see EUROPE 10762). The debate was relaunched in France in the middle of last December when a young French woman who had suffered from a VTE lodged a complaint, claiming that the VTE had been caused by a third-generation contraceptive pill. Around 15 other complaints were subsequently lodged. (IL/transl.fl)