歐洲藥品管理局(EMA)經(jīng)受益-風(fēng)險(xiǎn)評估后認(rèn)為, 口服酮康唑治療真菌感染的肝損害風(fēng)險(xiǎn)超過受益。因此, EMA決定暫停這類藥品在歐盟的上市許可。建議我國酮康唑口服制劑生產(chǎn)企業(yè)做酮康唑口服制劑的受益-風(fēng)險(xiǎn)評估, 決定下一步采取的安全性措施, 至少應(yīng)修訂藥品說明書。在我國銷售藥品的生產(chǎn)企業(yè)應(yīng)注意不斷收集國外藥品上市后的再評價(jià)信息, 并及時(shí)采取修訂說明書、暫停銷售或撤市等適當(dāng)?shù)娘L(fēng)險(xiǎn)控制措施, 確保用藥安全。

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.