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EMA to review third- and fourth-generation combined oral contraceptives


The EMA ( European Medicines Agency ) has 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.

France has made this request amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives by French women in favour of using second-generation oral contraceptives.

It is well established 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 ), and the risk differs between different generations of combined contraceptives. There is a higher risk for third- and fourth-generation contraceptives compared with first- and second-generation contraceptives.
Information about the risks of VTE is included in leaflets for patients and prescribers, and has been continuously updated. ( Xagena )

Source: European Medicines Agency, 2013

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