ST LOUIS (MD Consult) - On September 23, 2010, the US Food and Drug Administration (FDA) announced that Octapharma USA, Inc, has broadened its voluntary recall of Octagam (immune globulin intravenous [human]) 5% liquid preparation. In August 2010, the company announced the recall of 31 lots of Octagam in response to a perceived increased risk of thromboembolic events associated with product use. Because a root cause of the previously reported thromboembolic events has not yet been determined, Octapharma—in consultation with the public health authorities at the FDA—has now decided that it would be prudent to recall all lots of Octagam from the US market in the interests of public safety.

Octapharma has not received any additional reports of thromboembolic events since the August 2010 market withdrawal of Octagam. The product is indicated for the treatment of primary humoral immunodeficiency, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

圣路易斯(MD Consult)——2010年9月23日，美国食品药品管理局(FDA)宣布，美国Octapharma有限责任公司已扩大Octagam(人体静脉注射用免疫球蛋白) 5%液体制剂的主动召回范围。在意识到使用该产品有增加血栓栓塞风险后，该公司曾于2010年8月做出回应，宣布召回31个批次的Octagam。由于尚未明确之前所上报的血栓栓塞事件的根本原因，Octapharma公司与FDA公共卫生署协商后决定，为了公众的安全，将从美国市场召回所有批次的Octagam。

自2010年8月部分批次的Octagam撤市以来，Octapharma公司尚未收到另外的血栓栓塞事件报告。该制剂用于治疗原发性体液免疫缺陷病、普通变异型免疫缺陷病、X-连锁无丙种球蛋白血症、Wiskott-Aldrich综合征和重症联合免疫缺陷病。