EMA暂停使用口服酮康唑的受益–风险评估

Benefit-risk assessment on suspension of using oral ketoconazole by EMA

欧洲药品管理局(EMA)经受益–风险评估后认为,口服酮康唑治疗真菌感染的肝损害风险超过受益。因此,EMA决定暂停这类药品在欧盟的上市许可。建议我国酮康唑口服制剂生产企业做酮康唑口服制剂的受益–风险评估,决定下一步采取的安全性措施,至少应修订药品说明书。在我国销售药品的生产企业应注意不断收集国外药品上市后的再评价信息,并及时采取修订说明书、暂停销售或撤市等适当的风险控制措施,确保用药安全。

Based on the assessment of that the liver injury risk of oral ketoconazole used to cure fungus infection is greater than the benefit, EMA suspended marketing of this kind of drugs in EU. The national related pharmaceutical manufactures should startup the benefit-risk evaluation and decide the further safety measures, at least revise the instruction. The national pharmaceutical manufactures should pay more attention to collecting reevaluating information after drugs approved, and take necessary measures to control risk and ensure patients safety just like revising instructions, suspending marketing or withdrawal.