警报：某药企贴错标签，严重或致命，速召回

近日，FDA官网发布安全警报显示：费森尤斯卡比公司误将奥坦西隆注射液(用于预防和治疗由化疗和放疗引起的恶心呕吐或术后恶心)产品标签误贴为咪达唑仑注射液(用于麻醉前给药、全麻醉诱导和维持以及镇静)，并引起了召回。

　　根据该公告，这种误贴标签可能导致病人术前镇静作用失效和/或焦虑及严重的心率失常，甚至引起血清综合征，这将是致病的。

　　摘译如下：

　　Fresenius Kabi USA is voluntarily recalling Lot 6400048 of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection,USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL.

　　美国费森尤斯卡比主动召回批号为6400048的咪达唑仑注射液，USP，2mg/2mL，包装于一个2mL的一次性玻璃注射器中。该产品被误贴标签为咪达唑仑注射液，USP，2mg/mL，包含注射器容器，实际为奥坦西隆注射液，USP，4mg/mL。

　　A missed dose of midazolam may lead to ineffective sedation and/or anxiety related to patient recall of a surgical or diagnostic procedure. If a selection error occurs, a patient who may have received a pre-operative dose of ondansetron may inadvertently receive an additional dose of ondansetron. Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions. Patients may also be at risk for serotonin syndrome. Some of the reported cases of serotonin syndrome were fatal.

　　手术前本应该注射咪达唑仑的实际却用错药则可能导致镇静作用失效和/或焦虑。如果发生选择性错误，则本已经在术前进行奥坦西隆注射的病人，会在不知情的情况下注射了额外剂量的奥坦西隆。对于那些本身患有心脏病的患者，在打入更高剂量奥坦西隆后，将发生严重的心率失常，这与剂量有关。在一些报道中，还可能发生血清综合征，这是致病的。

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