一批巨细胞病毒性视网膜炎药物Vistide被召回

圣路易斯(MD Consult)——2013年2月16日，美国食品药品管理局(FDA)宣布，吉利德科学公司正在自愿召回一批(批号B120217A)Vistide(西多福韦注射液)，原因是在这批产品的一些药瓶中发现了颗粒物质。这批Vistide已被销往美国、加拿大和欧洲的批发商、医院和零售药店。

静脉注射含颗粒物质的产品可能产生多种影响，具体取决于患者注射的颗粒物质的数量、颗粒的大小以及患者的基础疾病，有可能对患者产生严重影响。吉利德科学公司当前尚未收到任何由这些颗粒物质所致的投诉。

FDA建议医疗卫生专业人士检查所有注射用产品，并停止注射任何批号为B120217A的吉利德Vistide产品。

如在使用这种产品时发生不良反应或质量问题，应报告至FDA的MedWatch不良事件报告系统。

Vistide使用的适应证为治疗获得性免疫缺陷综合征患者的巨细胞病毒性视网膜炎。该产品作为静脉输注使用，通常在医院机构或医生诊室使用。

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ST LOUIS (MD Consult) - On February 16, 2013, the US Food and Drug Administration (FDA) announced that Gilead Sciences is conducting a voluntary recall of 1 lot (lot# B120217A) of Vistide (cidofovir for injection) because particulate matter was found in some vials from this lot. This lot of Vistide was distributed in the United States, Canada, and Europe to wholesalers and to hospital and retail pharmacies.

Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into the patient, the size of the particles, and the patient's underlying medical condition, and can be severe. Gilead is not currently aware of any complaint attributable to the particles.

The FDA advises health care professionals to inspect any injectable product, and to refrain from injecting any Gilead Vistide product with lot number B120217A.

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting Program.

Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. The product is administered as an intravenous infusion, and is typically given in a hospital setting or in a doctor's office.

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