關於拉米夫定(lamivudine)和替比夫定(telbivudine)安全性的最新資訊 Latest safety update on lamivudine and telbivudine

       已知橫紋肌溶解(rhabdomyolysis)是使用拉米夫定(lamivudine)和替比夫定(telbivudine)時所可能出現的不良反應, 雖然這兩個藥物的說明書已明確描述該不良反應, 但鑒於該不良反應的及時發現﹑診斷和治療對患者的預後有利, 國家食品藥品監督管理局再次提醒衛生專業人士, 警惕lamivudine和telbivudine引起橫紋肌溶解的風險, 該局的藥品不良反應監測中心近期發佈的《第30期藥品不良反應信息通報》中, 指某些病人使用了lamivudine或telbivudine後, 出現了嚴重的橫紋肌溶解。

       基於以上事實, 建議醫生

  • 處方上述藥物予病人時應謹慎, 充分考慮患者的病情以及可能潛在的風險。
  • 告知病人關於上述藥物潛在的風險
  • 監測病人某些生理指標的改變, 包括:

     @ 肌酸磷酸激酶水平

     @ 肝、腎功能

     @ 出現彌漫性肌肉疼痛、肌肉觸痛、肌無力、關節痛等症狀

  • 一旦患者出現上述症狀, 應立即停藥或採取相應的治療措施, 對於出現嚴重橫紋肌溶解的病人, 積極的救治措施能避免患者發生危及生命的代謝紊亂和急性腎功能衰竭

                                                                                                                                                                                                                                                            

        Patients using lamivudine and telbivudine may experience serious rhabdomyolysis.  Although rhabdomyolysis is one of the most well-known adverse drug reactions already documented on the product information of lamivudine and telbivudine.  Since identify, detect, diagnose and treat the patient(s) early enough for better prognosis and to hasten recovery, upon the The latest “No. 30 ADR Information Bulletin” issued by National Adverse Drug Reaction Monitoring(NADRM) Center describing reported case(s) of patients experiencing serious rhabdomyolysis upon the use of lamivudine and telbivudine, State Food and Drug Administration (SFDA), China remind health professionals about the risk of lamivudine and telbivudine.

        In view of the above, we would like to offer physicians the following advice:

  • exercise caution and conduct a thorough consideration incorporating patients’ disease states and possible and potential risks before selecting the drug of choice for a patient.
  • educate patients about the potential risks of these drug(s).
  • be vigilantly attentive about changes on patients’

   @ creatine kinase levels

   @ liver and kidney function tests

   @ developing diffuse muscle pain, muscle tenderness, muscle weakness, joint pain and other symptoms

  • discontinue the causative drug immediately or take appropriate measures as required if patient develops any of the above. For patients developing severe rhabdomyolysis while on treatment, initiate active treatment measures immediately can prevent life-threatening metabolic disorders and acute renal failure.

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