英国药品和保健产品管理局(mhra)2010年警示唑来膦酸的肾损害风险(英文)

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1、Intravenouszoledronicacid:adverseeffectsonrenalfunctionArticledate:April2010SummaryZoledronicacidisassociatedwithreportsofrenalimpairmentandrenalfailure,especiallyinpatientswithpre-existingrenaldysfunctionorotherriskfactors.Renalfunctionshouldbemeasuredbef

2、oreeachdose,andpatientsshouldbeadequatelyhydratedbeforetreatment.Renalfunctionmonitoringisrecommendedafteruseofzoledronicacidinat-riskpatients—especiallythosewithpre-existingrenalimpairment.Useinpatientswithsevererenalimpairmentisgenerallynotrecommended,bu

3、tmaybeconsideredfortumour-inducedhypercalcaemia,ifthebenefitsoutweightherisks.·Zoledronicacid5mgforinfusion(Aclasta▼)isusedfortheonce-yearlytreatmentofosteoporosisinpatientsatincreasedriskoffracture,andasasingledoseforthetreatmentofPaget’sdiseaseofthebone.

4、·Zoledronicacid4mgforinfusion(Zometa)isgivenevery3–4weeksforthereductionofbonedamageinadvancedmalignanciesinvolvingbone,andasasingledosefortumour-inducedhypercalcaemia.Zoledronicacidisassociatedwithreportsofrenalimpairmentandrenalfailure,especiallyinpatien

5、tswithpre-existingrenaldysfunctionorotherriskfactors.TheproductinformationforZometaalreadycontainsstrongwarningsandprecautionsregardingrenalimpairmentandrenalfailure.WarningsintheproductinformationforAclasta▼arebeingstrengthenedfollowingreportsofrenalfailu

6、reorrenalimpairmentwithitsuse.Therehavebeen139worldwidesuspectedreports(14fatal)ofrenalimpairmentorrenalfailureupto14August2009,andsixUKsuspectedreports(onefatal)ofrenalimpairmentorrenalfailureupto5March2010,followingtheadministrationofAclasta▼.Themajority

7、ofcaseswereassociatedwiththefirstdose,andgenerallyoccurredinpatientswithpre-existingrenaldysfunctionorotherriskfactors,including:advancedage;useofconcomitantnephrotoxicdrugsordiuretictherapy;ordehydration.Renalfailurerequiringdialysisorresultingindeathhaso

8、ccurredinsomeat-riskpatients.AletterwassenttohealthcareprofessionalsinMarch2010,regardingtheupdatedproductinformationforAclasta▼.Adviceforhealthcareprofessionals:Thefollowingprecautionsshouldbetakenintoaccoun