藥物警訊

SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood

AUDIENCE: Endocrinology, Family Practice

ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

BACKGROUND: SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.

These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin.

RECOMMENDATION: Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber.

Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels. See the FDA Drug Safety Communication for more information.

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

FDA發布藥物安全警訊，第2型糖尿病藥物sodium-glucose cotransporter-2 (SGLT2) inhibitors (canagliflozin、dapagliflozin、empagliflozin)可能導致酮酸中毒，嚴重需住院治療。FDA正持續調查相關安全議題並評估是否需修改此類藥品之仿單資訊。

SGLT2 inhibitors為經FDA核可用於治療第2型糖尿病之處方藥。第2型糖尿病若未接受治療可能衍生嚴重併發症，如視力喪失、神經與腎臟功能損害及心臟疾病。SGLT2 inhibitors使體內血糖隨尿液由腎臟排除，進而達到血糖降低的效果。

美國FDA建議正在服藥的病人應特別留意是否出現與酮酸中毒相關之症狀，若有疑似呼吸困難、噁心嘔吐、腹痛、意識改變、異常疲倦或嗜睡…等，應立即就醫。切勿自行停藥或改變服藥方式。

於給藥前應審慎評估病人是否出現酸中毒症狀，若有疑似情形，應立即停止服用SGLT2 inhibitors且進行相關處置。
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