Novartis、FDA修正Imatinib标签以反映心脏毒性风险

October19,2006--Novartis和美国食品及药物管理局(FDA)发一封信给健康照护专业人士，信中提到白血病药物imatinib(Gleevec,Glivec)的严重郁血性心脏衰竭和左心室功能不全之风险，并将之在药品标签上新；该信结论指出，任何有心脏病或心衰竭风险的人，应被谨慎监控使用此药，若有心衰竭症状出现应被及时治疗。

FDA和该公司对此标签的改变，是因为自然医学(Nature Medicine)期刊今年稍早的一篇报导，提到此药在10位慢性骨髓性白血病患之心脏毒性副作用的研究。

信中提到，我们藉此提供您有关Gleevec和自然医学线上版的一篇近来受到媒体关注的文章的讯息；信中，Novartis肿瘤部门之美国临床发展与医疗事务副总裁John Hohneker医师指出，因此药所致之心脏毒性副作用是属于NYHA class1且仍有正常左心室射出分率，相关资料可在自然医学网站上获得；些病患数本来就有类似状况，如高血压、糖尿病和冠状动脉疾病。

信中指出，因为自然医学期刊研究的出版，Novartis 回顾了所有现有的临床试验和其他报告的资料；信件的结论是，虽然心脏不良反应事件不常见，但严重郁血性心脏衰竭和左心室功能不全仍偶被报告，因此我们建议任何有心脏病或心衰竭风险的人，应被谨慎监控使用此药，若有心衰竭症状出现应被及时评估与治疗。

信中指出，标签的警语已经修改纳入此一建议，相关资料也可在FDA的MedWatch 网站看到。

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.