Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding
AUDIENCE: Critical Care Medicine, Nephrology, Patient, Pharmacy, Health Professional
ISSUE: FDA has analyzed recent data that indicate an increased risk of (i) mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with sepsis and those admitted to the ICU; and (ii) excess bleeding particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass. Refer to the FDA Safety Communication for more details about the data analysis.
FDA has concluded that HES solutions should not be used in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and a Boxed Warning to include the risk of mortality and severe renal injury is warranted. In addition, FDA has reviewed a meta-analysis of studies conducted in patients undergoing open heart surgery in association with cardiopulmonary bypass and has determined that an additional warning about excessive bleeding is needed in the Warnings and Precautions Section of the package insert.
BACKGROUND: Hydroxyethyl starch (HES) solutions are used for the treatment of hypovolemia (low blood volume) when plasma volume expansion is desired. Recent data have associated the use of these products with an increased risk of severe adverse events when used in certain patient populations.
RECOMMENDATION: Patients should be aware of the risks associated with the use of HES solutions and discuss these risks with their healthcare provider (refer to the FDA Safety Communication for detailed recommendations for patients).
Recommendations for Health Professionals include the following:
• Do not use HES solutions in critically ill adult patients including those with sepsis, and those admitted to the ICU.
• Avoid use in patients with pre-existing renal dysfunction.
• Discontinue use of HES at the first sign of renal injury.
• Need for renal replacement therapy has been reported up to 90 days after HES administration. Continue to monitor renal function for at least 90 days in all patients.
• Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding.
• Discontinue use of HES at the first sign of coagulopathy.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products 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
FDA分析近期數據資料，hydroxyethyl starch (HES) 輸注液可能會增加以下風險：
FDA建議hydroxyethyl starch (HES) 輸注液不應使用於重症成年病人，且須註記可能增加死亡率及嚴重腎臟損害風險之加框警語。此外，FDA回顧一項進行開心手術時使用體外循環之病人的整合分析研究，認為藥品仿單內之警告與注意事項中，需額外註記可能導致出血過多之警語。
hydroxyethyl starch (HES) 輸注液核可於治療低血容積症。近期的數據表示此藥使用於某些特定病人族群時可能會增加產生嚴重副作用的風險。
病人應知悉使用hydroxyethyl starch (HES) 輸注液之相關風險，且若有任何問題，應與醫療專業人員討論。
1. 重症病人不使用hydroxyethyl starch (HES) 輸注液。
3. 當發生腎功能惡化時，應立即停止使用hydroxyethyl starch (HES)。
4. 曾有因使用hydroxyethyl starch (HES) 輸注液90天以上導致需接受腎移植治療之案例。若需使用90天以上，需密切注意病人腎功能狀況。
6. 當出現凝血功能異常時應停止使用hydroxyethyl starch (HES)。