France to warn 1.6 million desogestrel users about a small meningioma risk

全国安全通知

France's medicines agency is preparing to write to about 1.6 million women who have used desogestrel-based contraception, informing them of a small increased risk of meningioma. Euronews reported that approximately 90,000 prescribing doctors will also receive information. The action turns an earlier European pharmacovigilance decision into a large national communication campaign affecting patients who use several common contraceptive brands.

警告关心梅尼吉奥马,在大脑和脊椎周围的膜中出现的肿瘤。 大多数甲状腺肿瘤是非癌症和缓慢生长,但它们的位置或大小可能会产生严重的神经学效应。 法国指南发现持久的头痛、视力变化、肌肉弱势、平衡或言语问题、记忆损失以及新或恶化的头痛,这些症状应引发医疗咨询。

低绝对风险,目标预防措施

Regulators emphasise that the absolute risk remains very low. Euronews cited French research estimating approximately one additional case associated with desogestrel for every 67,000 users overall, with higher risk after prolonged treatment. The European Medicines Agency separately estimated one additional meningioma for every 67,300 women using desogestrel- or etonogestrel-containing products, demonstrating why authorities are communicating caution without describing the medicines as broadly unsafe.

EMA的药物监测风险评估委员会在审查一项大型法国流行病学研究后,建议更新产品信息。 新措施使药物不适合目前患有或以前患有<unk>疹的患者。 他们还指示临床医生考虑预先接触与肿瘤相关的其他前提物质,并在诊断中停止服用药物。

病人和诊所应该做什么

法国当局不建议患者自行停止避孕。 突然,未计划的变化可能会产生其他健康后果,包括意图不孕。 相反,用户被告知要与医生、妇科医生或中妇医生讨论他们的个人历史、治疗时间和任何有关症状的症状。 避孕选择应定期重新审查,图像考虑到症状或医学史证明了这一点。

接下来的阶段是实施:信件必须到达患者,处方人员必须包含修订的反指示,产品信息必须准确地传达风险和小规模。 药品监测系统将继续监测已知案例和延长曝光的影响。 发展是公共卫生规则的后果,但它既不是军事罢工,也不是停火,因此没有地图警报。