Zicam鼻用凝胶因疑似细菌污染而被召回

圣路易斯(MD Consult)——2012年12月18日，美国食品药品管理局(FDA)宣布，Matrixx Initiatives公司正在主动召回1个批次(批号# 2J23，有效期至2015年9月)的Zicam超强鼻塞舒缓鼻用凝胶。该公司在对该批次产品的1次抽样样品中发现少量洋葱伯克霍尔德菌(Burkholderia cepacia)，随即采取这项行动。上述问题是在对生产设备进行例行检查时被发现的，但对该批次产品追加抽样检查未发现上述微生物证据。

洋葱伯克霍尔德菌对于健康人群几乎没有医学风险，但鼻用喷剂中的洋葱伯克霍尔德菌可在免疫功能低下或囊性纤维化等慢性肺部疾病患者的上呼吸道定植，并继发呼吸道感染。该微生物对多种抗生素耐药，一旦感染上述易感人群后就难以被杀灭。Matrixx公司还没有收到相关疾病的报告。

该产品为非滴入液体鼻用凝胶，被用作鼻血管收缩药物。

与使用这些被召回产品有关的不良反应可报告至FDA的MedWatch 不良事件报告系统。

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ST LOUIS (MD Consult) - On December 18, 2012, the US Food and Drug Administration (FDA) announced that Matrixx Initiatives is voluntarily recalling 1 lot (lot# 2J23, expiration 09/15) of Zicam Extreme Congestion Relief nasal gel. The company is taking this step after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism.

Burkholderia cepacia poses little medical risk to healthy persons. However, B cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in persons with immune system compromise or in those with chronic lung conditions, such as cystic fibrosis. The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs. Matrixx has not received any reports of illness.

The affected product is a non-drip liquid nasal gel, and is used as a nasal decongestant.

Adverse reactions related to use of the recalled products may be reproted to the FDA's MedWatch Adverse Event Reporting Program.