藥物警訊

Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns

AUDIENCE: Pulmonology, Pediatrics, Nursing, Critical Care Medicine

ISSUE: FDA is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem was stopped. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information.

BACKGROUND: FDA identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, the active ingredient in Proglycem, since the drug was approved in 1973.

RECOMMENDATION: Proglycem is usually given in the hospital, and health care professionals should closely monitor babies receiving it, especially those with risk factors for pulmonary hypertension such as meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease. Stop Proglycem treatment if pulmonary hypertension is identified.

Parents and caregivers of any child receiving Proglycem should watch for signs of difficulty breathing such as flaring nostrils, grunting, unusual movement of their child's chest, rapid breathing, difficulty feeding, or a bluish color of the lips or skin. Immediately alert your child's health care professionals if you see any of these signs, and talk to them if you have any questions or concerns about Proglycem.

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

美國FDA接獲11起新生兒及嬰兒使用治療低血糖藥物ProglycemⓇ (diazoxide)後發生肺高壓之案例報告，該藥品於1973年於美國核准上市，所有案例皆於停藥後症狀改善或康復。美國FDA目前正持續進行此藥品之安全性評估。

ProglycemⓇ (diazoxide) 通常於醫院給藥，且需有醫療人員在旁密切觀察病人情況，尤其是具有胎便吸入症候群、新生兒呼吸窘迫症候群、新生兒暫時性呼吸急促、肺炎、敗血症、先天性橫隔膜缺失和先天性心臟病等危險因子的病人。若評估有發生肺高壓現象應立即停藥。

接受ProglycemⓇ治療之兒童的家長及照顧者應注意孩子是否出現呼吸困難現象，如鼻子皺起、呼嚕聲、胸腔異常起伏，呼吸急促、餵食困難或嘴唇、皮膚發紫，應立即向醫療人員尋求協助。

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