Watchdog to look again at new pill
France wins rethink by European drugs agency as Diane 35 contraceptive is linked to up to seven deaths
FRANCE has asked the European Medicines Agency drugs watchdog to look again at new-generation birth control pills – and to restrict their use as they may have a higher risk of dangerous blood clots.
It is concerned in particular by the Bayer drug Diane 35, which has been directly implicated in four deaths and indirectly in three others. Diane 35 is a drug sold to treat acne but it also reduces ovulation and has been prescribed as an oral contraceptive.
The EMA said 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”.
It added: “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.”
Earlier this month the EMA issued a report saying there was no new evidence of any safety risk from the so-called 3rd and 4th generation pills.
However, Le Figaro, citing a report from the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), noted possibly life-threatening and “undesirable” side-effects in 125 women who had taken Diane 35 or a generic. They were aged around 25.
France has already said it will no longer reimburse prescriptions for these pills and wants doctors to opt for 2nd generation pills. It says that the risk from the new generation pills is higher than the older contraceptives.
The ANSM has said 325,000 women in France use Diane 35 and has said that it should no longer be prescribed as a contraceptive. It is thought that 2.5million take 3rd and 4th generation pills and they are popular as they reduce side effects such as acne and increased weight.
