藥物警訊

Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients

AUDIENCE: Pulmonology, Infectious Disease, Pharmacy

ISSUE: The FDA has concluded that Doribax (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia.

BACKGROUND: In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm.

RECOMMENDATION: Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections (pyelonephritis).

Read the MedWatch safety alert, including links to the FDA Drug Safety Communication and prescribing information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA分析抗微生物藥品Doribax (doripenem)在2011年因安全性問題終止之臨床試驗，Doribax (doripenem)若用於治療呼吸器相關之肺炎，相較於imipenem和cilastatin，可能會增加死亡風險且降低臨床效益。FDA已核准藥品之仿單變更，新增相關風險說明。Doribax目前未核准使用於任何類型之肺炎治療。

此提早終止之臨床試驗中，患有呼吸器相關之細菌性肺炎病人分別接受7天doripenem治療或10天imipenem和cilastatin治療。分析兩組之28天所有原因死亡率，Doribax組相較於使用imipenem-cilastatin組來的高，且Doribax組之臨床效益也相對較低。

醫療人員在治療患有呼吸器相關之肺炎病人之前，應權衡使用此藥品之利弊，Doribax用於FDA核可之適應症時仍為安全且有效，如複雜性腹腔內感染和複雜性泌尿道感染，包含腎臟感染症（腎盂腎炎）。

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