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Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Audience - HIV/AIDS, Infectious Disease healthcare professionals
FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System. Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication. FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.
Read the complete MedWatch 2010 Safety summary including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA發佈藥物安全警訊，告知醫護人員和病人關於使用治療人類免疫缺乏病毒（HIV）感染藥物Videx或Videx EC (didanosine)的病人有發生罕見而嚴重之非肝硬化門脈高壓併發症的風險。FDA從不良反應通報系統的通報報告中得知非肝硬化門脈高壓的案例。基於許多證據充足的案例並排除其他造成肝門靜脈高壓的原因(如酒精引起的肝硬化或C型肝炎)，FDA推論didanosine的使用和非肝硬化門脈高壓的發生是具有相關性的。由於肝門靜脈高壓的潛在嚴重性，包括食道靜脈曲張出血致死，FDA已更新didanosine藥物仿單中藥物警訊及使用注意事項的內容，以確保藥物使用的安全。FDA相信對於某些感染HIV的病人，使用didanosine治療的臨床助益仍是遠超過可能發生的風險。然而是否使用此藥治療必須視醫師與病人的個別情況而定。
[Posted 01/29/2010]
相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm
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
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資料來源：藥師週刊 第1670期
