一批甲磺酸苯扎托品因可能含玻璃颗粒而被召回

圣路易斯(MD Consult)——2013年6月30日，美国食品药品管理局(FDA)宣布，因药瓶中可能存在玻璃颗粒(玻璃层剥离)，美国费森尤斯卡比公司正在主动召回4个批次(批号030712、 071212、090512和 111412)的甲磺酸苯扎托品瓶装2 ml单剂量2 mg/2 ml注射剂。迄今为止，尚未收到任何不良事件、患者反应或消费者投诉的报告。该公司已暂停甲磺酸苯扎托品的销售。

如果经非胃肠道途径使用的药物中存在玻璃颗粒，使用这种药物的患者可能发生危险。病例报告提示，可能发生血栓栓塞，一些情况下甚至可能危及生命(如肺栓塞)。文献中的一些报告提示，颗粒可能导致静脉炎、毛细血管或小动脉机械性阻塞、血小板活化，继而产生微血栓和栓塞。已有创伤或对微血管血液供应存在不利影响的其他疾病的患者风险进一步增高。应用含玻璃颗粒的药物也可能导致肉芽肿形成，这是机体对异物的一种保护性局部炎症反应，一般不严重。

甲磺酸苯扎托品用于对所有类型震颤麻痹症的辅助治疗，也用于控制与安定药使用相关的锥体外系异常。

如发生与这些产品有关的不良事件或质量问题，应报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On June 30, 201, the US Food and Drug Administration announced that Fresenius Kabi USA is conducting a voluntary recall of 4 lots (lot# 030712, 071212, 090512, and 111412) of benztropine mesylate for injection in 2 mg/2 mL (1 mg/mL) in 2-mL single-dose vials because of the potential presence of glass particles (glass delamination) in the vials. No adverse events, patient reactions, or customer complaints have been reported to date. The company has discontinued distribution of benztropine mesylate while it investigates the cause.

The administration of glass particulates, if present in a parenteral drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (eg, pulmonary emboli), may occur. Some reports in the literature suggest that particulates can possibly cause phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting trauma or other medical conditions that adversely affect the microvascular blood supply are at an increased risk. Administration of glass particulates can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.

Benztropine mesylate is used as an adjunct in the therapy of all forms of Parkinsonism. It is also used in the control of extrapyramidal disorders associated with the use of neuroleptic drugs.

Adverse events or quality problems related to use of these products should be reported to the FDA's MedWatch Adverse Event Reporting Program.