ST LOUIS (MD Consult) - On September 1, 2010, the US Food and Drug Administration (FDA) announced that sections of the drug label for the intravenous antibacterial Tygacil (tigecycline) are being changed to include information regarding an increase in the mortality risk in patients treated with the drug. The increased risk was determined using a pooled analysis of clinical trial data. Although the cause of the excess death in these trials was often uncertain, the FDA believes that it is likely that most deaths in patients with severe infections were related to progression of the infection.

The increased mortality risk was seen most clearly in trial patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia. It was also seen in patients with complicated skin and skin structure infections, complicated intraabdominal infections, and diabetic foot infections.

Tygacil is approved by the FDA for the treatment of complicated skin and skin structure infections, complicated intraabdominal infections, and community-acquired pneumonia. However, it is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infections.

The greatest increase in the risk of death with Tygacil use in the clinical trials was seen in patients with ventilator-associated pneumonia. Tygacil is not approved for the treatment of ventilator-associated pneumonia because of an unacceptably low cure rate, as well as excess mortality.

The FDA advises that alternatives to Tygacil should be considered for the treatment of patients with severe infections.

圣路易斯(MD Consult)——2010年9月1日，美国食品药品管理局(FDA)宣布，生产商正在对静脉注射用抗生素替格环素(Tygacil)药品说明书的部分内容进行更改，添加关于接受此药治疗的患者死亡风险增加的信息。风险增加这一结论是经过对临床试验数据进行荟萃分析后确定的。尽管尚不明确这些试验中死亡增加的原因，但FDA认为大多数重度感染患者的死亡可能与感染加重有关。

 

应用替格环素治疗医院获得性肺炎(尤其是呼吸机相关性肺炎) 的受试者死亡风险增加最明显。另外，并发皮肤和皮肤结构感染、并发腹内感染以及合并糖尿病足感染的患者死亡风险也明显增加。

 

替格环素经FDA批准用于治疗并发性皮肤和皮肤结构感染、并发性腹内感染和社区获得性肺炎。然而，该药并未获准用于治疗医院获得性肺炎(包括呼吸机相关性肺炎)或糖尿病足感染。

 

在临床试验中，呼吸机相关性肺炎患者应用替格环素治疗后死亡风险增幅最大。由于替格环素对呼吸机相关性肺炎的治愈率很低且死亡率过高，故其获准的适应证中未包括此病。

 

FDA建议对重度感染者应考虑选用替格环素治疗。