藥物警訊

Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death

AUDIENCE: Infectious Disease, Critical Care, Pharmacy

ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.

This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

BACKGROUND: Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

RECOMMENDATION: Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.

Read the MedWatch alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
 

FDA新增Tygacil之加框警語，說明此藥用於FDA核准或未核准的適應症時，皆可能增加死亡風險。此訊息主要源自於FDA在2010年9月發布相關安全警訊後，為了能使FDA繼續核准使用所進行之額外分析。

此分析表示，相較於其他抗生素，使用Tygacil之病人具有較高的死亡風險：2.5% (66/2640) vs. 1.8% (48/2628)，校正後之死亡風險差異為0.6% (95% CI, 0.0-1.2%)。死亡原因主要為感染惡化、感染併發症或其他潛在因素。

Tygacil為FDA核准用於治療複雜性皮膚及皮膚結構感染 (cSSSI)，複雜性腹內感染 (cIAI)，和社區性肺炎 (CABP)。
FDA建議醫療人員，應當其他替代藥物治療皆不適用之情況下，再考慮使用Tygacil。
 

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部