The European Medicines Agency confirms the positive benefit / risk ratio of the latest generation pills.
Never two without three ! France has just suffered this Friday a third snub from Europe! After the opinion of the European Medicines Agency (EMA), issued on May 30, which declared itself in favor of maintaining the anti-acne drug Diane 35 on the European market, the same Agency estimates that the benefits of the pills of third and fourth generations continue to outweigh their risks. The standoff between Europe and France over the proper use of contraceptive pills continues! The EMA is also following the conclusions of the Pharmacovigilance Risk Assessment Committee, Prac, presented last October. In its reassessment, the European Agency further considers that the risk of venous thromboembolism “is low with all hormonal contraceptives combined”.
Europe tells patients to continue treatment
As a result, Europe does not recommend stopping treatment if no problem has been observed, but nevertheless stresses the need to provide patients and prescribers with “clear and up-to-date” information on the risks associated with the use of these drugs.
“Product information will be updated to help women choose their contraception in an informed way with their doctor,” said the EMA, for example. And the latter adds that, “the doctor must also take into account the risk of the contraceptive he prescribes compared to other combined hormonal contraceptives. “
Certain factors increase the risk of thromboembolism
Because in its press release, Europe also recalls that the risk of venous thromboembolism increases with certain factors: overweight, age, prolonged immobilization or family history. The risk is also higher during the first year of use of combined hormonal contraceptives, she recalls. In addition, the risk of arterial thromboembolism, responsible for cerebrovascular accidents (CVA) and infarction, has also been reassessed. It was concluded by the EMA that this risk was very low and that there was no evidence of a difference in the level of risk between contraceptives depending on the type of progestin.
Pending the Commission’s opinion, France maintains its restrictions
In this story, it was the EMA’s Prac that was initially contacted at the request of France on the question of the thromboembolic risk of these contraceptives, compared to older oral contraceptives (1G and 2G pills) . This request from Marisol Touraine, made last January, also asked the European Agency if a restriction of the second-line indications of new generation pills was not necessary.
These two EMA opinions will now be submitted to the European Commission, the only authority empowered to issue a final opinion binding on the States. Pending this decision, the Medicines Safety Agency (ANSM) still recommends, for the moment, the preferential use of 1st and 2nd generation pills for France.
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