由於使用奎寧(quinine)於夜間腿抽筋(night time leg cramps)一類未獲核准的適應症時, 持續有嚴重不良反應的報告, 美國食物及藥物管理局(USFDA)警告不要處方該藥於此未批准的用途。目前quinine只獲批准用於治療由惡性瘧原蟲(Plasmodium falciparum)引起的非複雜性瘧疾(uncomplicated malaria), 這一罕見的傳染病主要發生於自瘧疾流行地區歸來的旅遊人士, 並不可用於治療夜間腿抽筋。
使用quinine可引起嚴重且致命的血液不良反應, 包括由於血小板減少(thrombocytopenia)而導致的嚴重出血, 以及可導致某些病人永久腎損害的溶血尿毒綜合症(hemolytic-uremic syndrome)或血栓性血小板減少性紫癜(thrombotic thrombocytopenic purpura), 這些不良反應甚至導致某些病人住院和死亡。目前並沒有證據顯示該藥可用於預防或治療夜間腿抽筋, 用於該適應症的風險高於其潛在的效益。
基於此, 衛生專業人士應掌握以下資訊：
- Quinine只批准用於治療由Plasmodium falciparum引起的非複雜性瘧疾。
- uinine並未獲批准用於預防或治療夜間腿抽筋, 使用quinine於該適應症時可導致病人出現嚴重的不良反應。
- 告知病人警惕出現血小板減少的症狀, 如容易瘀傷﹑嚴重鼻出血﹑尿液或糞便帶血﹑牙齦出血以及皮膚出現不尋常的紫色﹑棕色或紅色斑點。
Due to continued reports of serious side effects in patients using quinine "off-label" for night time leg cramps, the U.S. Food and Drug Administration (USFDA) warned against the use of this drug for such unapproved uses. Quinine is ONLY approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, a rare infection primarily in travelers returning from malaria-endemic areas. Quinine should not be used for night time leg cramps.
Quinine use may result in serious and life-threatening blood-related (hematological) reactions, including serious bleeding due to thrombocytopenia, and a condition known as hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death. The absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.
Information for Healthcare Professionals
- Quinine is only approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum.
- Quinine is NOT approved for the treatment or prevention of night time leg cramps. Prescribing Quinine for this condition exposes patients to risk for serious adverse events.
- Discuss with patients the warning signs of thrombocytopenia such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin.