Novartis、FDA修正Imatinib標(biāo)簽以反映心臟毒性風(fēng)險(xiǎn)

醫(yī)案日記 2023-05-08 06:36:15

Novartis
、FDA修正Imatinib標(biāo)簽以反映心臟毒性風(fēng)險(xiǎn)

October19,2006--Novartis和美國食品及藥物管理局(FDA)發(fā)一封信給健康照護(hù)專業(yè)人士

，信中提到白血病藥物imatinib(Gleevec,Glivec)的嚴(yán)重郁血性心臟衰竭和左心室功能不全之風(fēng)險(xiǎn)

，并將之在藥品標(biāo)簽上新

；該信結(jié)論指出

，任何有心臟病或心衰竭風(fēng)險(xiǎn)的人

，應(yīng)被謹(jǐn)慎監(jiān)控使用此藥

，若有心衰竭癥狀出現(xiàn)應(yīng)被及時(shí)治療

。

FDA和該公司對此標(biāo)簽的改變，是因?yàn)樽匀会t(yī)學(xué)(Nature Medicine)期刊今年稍早的一篇報(bào)導(dǎo)

，提到此藥在10位慢性骨髓性白血病患之心臟毒性副作用的研究

。

信中提到

，我們藉此提供您有關(guān)Gleevec和自然醫(yī)學(xué)線上版的一篇近來受到媒體關(guān)注的文章的訊息

；信中，Novartis腫瘤部門之美國臨床發(fā)展與醫(yī)療事務(wù)副總裁John Hohneker醫(yī)師指出

，因此藥所致之心臟毒性副作用是屬于NYHA class1且仍有正常左心室射出分率

，相關(guān)資料可在自然醫(yī)學(xué)網(wǎng)站上獲得；些病患數(shù)本來就有類似狀況

，如高血壓

、糖尿病和冠狀動(dòng)脈疾病。

信中指出

，因?yàn)樽匀会t(yī)學(xué)期刊研究的出版

，Novartis 回顧了所有現(xiàn)有的臨床試驗(yàn)和其他報(bào)告的資料；信件的結(jié)論是

，雖然心臟不良反應(yīng)事件不常見

，但嚴(yán)重郁血性心臟衰竭和左心室功能不全仍偶被報(bào)告，因此我們建議任何有心臟病或心衰竭風(fēng)險(xiǎn)的人

，應(yīng)被謹(jǐn)慎監(jiān)控使用此藥

，若有心衰竭癥狀出現(xiàn)應(yīng)被及時(shí)評(píng)估與治療。

信中指出

，標(biāo)簽的警語已經(jīng)修改納入此一建議

，相關(guān)資料也可在FDA的MedWatch 網(wǎng)站看到。

Novartis,FDA Revise Imatinib Label to Reflect Cardiotoxicity Risk

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.