[Posted 09/01/2021]
TOPIC: Janus Kinase (JAK) Inhibitors: Drug Safety Communication - FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death (2)
RECOMMENDATIONS:
Patients who are taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq should tell their health care professional if they are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put them at higher risk for serious problems with the medicines. Patients starting these medicines should also tell their health care professional about these risk factors. Patients should seek emergency help right away if they have any symptoms that may signal a heart attack, stroke, or blood clot. Treatment with these medicines is associated with an increased risk of certain cancers including lymphoma and lung cancer. Patients should also talk to their health care professional if they have any questions or concerns.
Health Professionals should consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Xeljanz/Xeljanz XR, Olumiant, or Rinvoq. This is particularly the case in patients who are current or past smokers, those with other cardiovascular risk factors, those who develop a malignancy, and those with a known malignancy other than a successfully treated nonmelanoma skin cancer. Reserve these medicines for patients who have had an inadequate response or intolerance to one or more TNF blockers. Counsel patients about the benefits and risks of these medicines and advise them to seek emergency medical attention if they experience signs and symptoms of a heart attack, stroke, or blood clot.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/OkALeR
建議：
正在服用Xeljanz/Xeljanz XR、Olumiant或Rinvoq的病人應告訴醫療專業人員，是否有抽菸(不論過去或現在)、或曾經有過心臟病發作、其他心臟相關疾病、中風或血栓之病史，因為這些因子可能增加此類藥品的嚴重不良反應風險。開始使用這些藥品前，病人應將上述危險因子告知醫療專業人員。若病人出現任何心臟病發作、中風或血栓症狀之徵兆，應立即至急診就醫。使用這些藥物進行治療，可能會增加罹患某些癌症的風險，包括淋巴瘤和肺癌。若病人有任何問題或疑慮，也應與醫療專業人員聯繫。
在病人開始或持續使用Xeljanz/Xeljanz XR、Olumiant或Rinvoq進行治療前，醫療專業人員應考慮個別患者的益處和風險。尤其是針對目前或過去有吸煙的患者、具有其他心血管危險因子的患者、進展為惡性腫瘤的患者以及患有除了已治療成功的非黑色素瘤皮膚癌外的已知惡性腫瘤的患者。保留此類藥物供對TNF抑制劑反應不足或不耐受的患者使用。告知病人這類藥物的益處和風險，並建議他們在出現心臟病發作、中風或血栓的跡象和症狀時立即至急診就醫。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/OkALeR
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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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