主页 > 医学信息 >
【drug-news】FDA发布有关静脉用抗菌素替加环素的
[Posted 09/01/2010]
AUDIENCE: Infectious Disease, Critical Care Medicine, Internal Medicine
ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.
BACKGROUND: Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. The increased risk was determined using a pooled analysis of clinical trials. See the Data Summary section of the FDA Drug Safety Communication for additional details.
RECOMMENDATION: Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
source:www.fda.gov
Tygacil (tigecycline): Label Change - Increased Mortality Risk
Tygacil（替加环素）：标签变更——增加死亡风险
[Posted 09/01/2010]
发布日期：2010年9月1日
AUDIENCE: Infectious Disease, Critical Care Medicine, Internal Medicine
信息发布对象：感染性疾病，重症监护医学，内科学
ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.
事件：FDA提醒医护人员，与其他用于治疗各种严重感染的药物相比，使用静脉注射用抗菌素Tygacil（替加环素tigecycline）可能增加死亡风险。该风险最常见于用于治疗医院获得性肺炎的患者，特别是因换气机而引起的肺炎患者，另外，这种风险在伴有复杂性皮肤和皮肤结构感染、复杂性腹内感染以及糖尿病足感染的患者中也有发生。目前，FDA已更新了Tygacil的药品标签以纳入有关该药可能增加死亡风险的信息。
BACKGROUND: Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. The increased risk was determined using a pooled analysis of clinical trials. See the Data Summary section of the FDA Drug Safety Communication for additional details.
背景：FDA已批准Tygacil用于治疗复杂性皮肤和皮肤结构感染、复杂性腹内感染和社区获得性肺炎。但该药尚未被批准用于医院获得性肺炎（包括因换气机而引起的肺炎）或糖尿病足感染。Tygacil可能引起死亡率增加的风险是通过一项临床试验的荟萃分析而被确认的。其他详细信息可见FDA药品安全信息沟通的数据摘要栏目。
RECOMMENDATION: Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
•Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
•Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-03-01 11:59
医学,生命科学网