FDA批准更改Doribax标签以警示药物风险

• 出 处: 世界临床药物
• 发表日期: 2004年期
• 关键词: 标签 肾脏感染 抗生素药品 肾盂肾炎 泌尿道感染 腹腔内感染 呼吸机 强生公司 FDA Doribax

2013年3月,FDA批准更改强生公司抗生素药品多尼培南(doripenem,Doribax)的标签,以警示该药可能增加呼吸机相关性肺炎患者的死亡风险。FDA在声明中表示,多尼培南没有被批准用于治疗任何类型的肺炎,且在更改后的药物标签中强调了这一点。此外,医务专业人员应当考虑使用呼吸机引起肺炎的可能,评估接受多尼培南治疗的益处是否超过其潜在风险。对于成人并发腹腔内感染和泌尿道感染(包括肾脏感染如肾盂肾炎),多尼培南仍是安全有效的治疗方案。

In March 2013, the FDA approved a change of label for Johnson & Johnson's antibiotic drug doripenem (Doribax) to warn that it may increase the risk of death in patients with ventilator-associated pneumonia. The FDA said in a statement that donepezil was not approved for the treatment of any type of pneumonia, as highlighted in the revised drug label. In addition, healthcare professionals should consider the possibility of ventilator-induced pneumonia and assess whether the benefits of receiving dronedarpen exceed their potential risks. For adult patients with intra-abdominal and urinary tract infections (including renal infections such as pyelonephritis), dronedarpen is still a safe and effective treatment.