October19,2006--Novartis和美國食品(pin)及藥(yao)物(wu)管(guan)理局(FDA)發一封信給(gei)健康照護專業(ye)人(ren)士(shi)，信中(zhong)提到白血(xue)病(bing)藥(yao)物(wu)imatinib(Gleevec,Glivec)的嚴重郁血(xue)性(xing)心(xin)臟衰竭和左心(xin)室(shi)功能不(bu)全之風(feng)險(xian)，并將之在藥(yao)品(pin)標簽上(shang)新；該(gai)信結(jie)論(lun)指出，任何有(you)心(xin)臟病(bing)或心(xin)衰竭風(feng)險(xian)的人(ren)，應被謹慎監控(kong)使(shi)用(yong)此藥(yao)，若(ruo)有(you)心(xin)衰竭癥狀(zhuang)出現應被及時治療。
FDA和該(gai)公司對此標簽的改變，是因為(wei)自然醫學(Nature Medicine)期刊今年稍早的一篇報導，提到此藥在10位(wei)慢性(xing)骨髓性(xing)白血(xue)病患之心臟毒性(xing)副作用的研(yan)究。
信(xin)中提到，我們藉此提供(gong)您有(you)關(guan)Gleevec和自然醫(yi)(yi)學線上版的一(yi)篇近(jin)來受(shou)到媒體關(guan)注的文章(zhang)的訊(xun)息；信(xin)中，Novartis腫(zhong)瘤部門之美(mei)國(guo)臨床發展與醫(yi)(yi)療(liao)事務(wu)副(fu)總裁John Hohneker醫(yi)(yi)師指出，因(yin)此藥(yao)所致(zhi)之心(xin)臟毒性副(fu)作用是屬于NYHA class1且仍有(you)正常(chang)左心(xin)室射出分率，相關(guan)資料可在自然醫(yi)(yi)學網(wang)站上獲得；些(xie)病患數本來就有(you)類似狀(zhuang)況(kuang)，如(ru)高血壓(ya)、糖尿病和冠狀(zhuang)動脈(mo)疾病。
信中指出(chu)，因為自然(ran)醫學期(qi)刊(kan)研究的(de)出(chu)版，Novartis 回顧了(le)所有(you)現有(you)的(de)臨(lin)床試驗和其他報告(gao)(gao)的(de)資料；信件(jian)的(de)結論(lun)是，雖然(ran)心(xin)臟不良反應(ying)事件(jian)不常見，但嚴重郁血性心(xin)臟衰(shuai)竭和左心(xin)室功能不全仍偶被報告(gao)(gao)，因此我們建議任何有(you)心(xin)臟病或(huo)心(xin)衰(shuai)竭風險的(de)人，應(ying)被謹慎監控使用此藥，若有(you)心(xin)衰(shuai)竭癥(zheng)狀出(chu)現應(ying)被及時評估與治(zhi)療。
信中指出，標簽(qian)的(de)(de)警語已經修改(gai)納入此一(yi)建議，相關資料(liao)也可在FDA的(de)(de)MedWatch 網站(zhan)看到。
Novartis,FDA Revise Imatinib Label to Reflect Cardiotoxicity Risk
By
Medscape Medical News
October19,2006— Novartis and the US Food and Drug Administration(FDA)have sent a letter to healthcare professionals to clarify the risk of severe congestive heart failure and left ventricular dysfunction in patients taking the leukemia drug imatinib(Gleevec,Glivec)and to update them on changes to the drug label.The letter concludes that anyone with known heart disease or risk factors for heart failure should be monitored carefully and treated if heart failure symptoms arise.
The move on the part of the agency and drug maker comes after a study appeared in Nature Medicine earlier this year reporting cardiotoxic side effects of the drug in10patients with chronic myelogenous leukemia.
"We are writing to provide you information regarding Gleevec and an article published online in Nature Medicine,which recently received media coverage," the letter reads.In it,John Hohneker,MD,vice president,US clinical development and medical affairs in the oncology division at Novartis,notes that supplemental data available on the Nature Medicine Web site indicates that all of the patients who suffered cardiotoxic side effects from the drug had NYHA class1functioning and normal left ventricular ejection fractions."Most of these patients had preexisting conditions,including hypertension,diabetes,and coronary artery disease," Hohneker notes.
Since the publication of the Nature Medicine study,Novartis has reviewed all available data from clinical trials and other reports,the letter notes.It concludes:"While cardiac events remain uncommon,severe congestive heart failure and left ventricular dysfunction have occasionally been reported.As such we believe any patients with known cardiac disease or risk factors for cardiac failure should be monitored carefully,and any patient with symptoms consistent with cardiac failure should be evaluated and treated."
The precautions section of the label have been modified to include this recommendation,the letter notes.The information also appears on the FDA's MedWatch Web site.
Nat Med.2006;12:908-916.
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