EMA药物警戒风险评估委员会将严格控制患者对甲氨蝶呤和环丙孕酮的服用

2019-07-17 不详 MedSci原创

欧洲药品管理局(EMA)药物警戒风险评估委员会(PRAC)建议采取新措施,以避免导致一些患者每天误服含甲氨蝶呤的药物。该决定是在委员会7月8日至11日的最新会议上做出的,该会议审查了现有证据,并建议采取其他措施减少剂量误差。

欧洲药品管理局(EMA)药物警戒风险评估委员会(PRAC)建议采取新措施,以避免导致一些患者每天误服含甲氨蝶呤的药物。该决定是在委员会7月8日至11日的最新会议上做出的,该会议审查了现有证据,并建议采取其他措施减少剂量误差。

这些措施包括限制谁可以开出药物处方,使包装上的警告更加突出,并为患者和医疗保健专业人员提供教育材料。此外,为了帮助患者按照每周一次的剂量给药,每周使用的甲氨蝶呤片剂将以泡罩包装提供,而不是在瓶子或管中。

安全委员会还开始审查含有环丙孕酮的药物,这些药物用于治疗一系列疾病,包括过度毛发生长,前列腺癌和痤疮,以及激素替代疗法。

环丙孕酮的控制是为了降低脑膜瘤的风险 。脑膜瘤是一种罕见的非恶性肿瘤,覆盖大脑和脊髓,其在体内的位置可能导致严重的健康问题。最近法国的一项研究表明脑膜瘤的风险虽然非常低,但长期服用高剂量环丙孕酮的人群可能会增加。

PRAC表示,它现在将审查现有的证据,并就整个欧盟使用含有环丙孕酮的药物提出建议。

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    2019-07-19 fengyi812
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    2019-07-19 周虎
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