The European Medicines Agency says it has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict their use.
The review comes after growing media reports about combined contraceptives and venous thromboembolism - blood clots in veins, and follows moves by the French government to stop reimbursement of third and fourth-generation pills and restrict their use. The latter has acted after a woman sued German group Bayer after suffering a stroke, caused by a blood clot, after using Meliane (gestodene/ethinylestradiol).
Also, earlier this week, the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) has launched an investigation into Bayer's acne drug Diane 35 (cyproterone/ethinylestradiol which is sold in some countries (but not France) as a contraceptive and marketed as Dianette. Four deaths in France due to thrombosis have been linked to the use of Diane-35.
Earlier this month, the EMA issued a report saying there was no new evidence of any safety risk from third- and fourth-generation pills. However, the agency’s Pharmacovigilance Risk Assessment Committee will now review whether currently available product information may need changing. The EMA adds that this is the first time that member states have requested an EU-wide recommendation for these medicines under the framework of its new pharmacovigilance legislation.
The agency goes on to say that "it is well established that combined contraceptives carry a very rare risk of VTE". It adds that "the absolute risk is very small (between 20 and 40 cases per 100,000 women in one year of use) and…there is a higher risk for third- and fourth-generation contraceptives compared with first- and second-generation".
More information about the review by the PRAC will be published following the next meeting of the committee on February 4-7.
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