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Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels a

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URL:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm

摘 要:

FDAisstrengtheningthecurrentwarningsintheprescribinginformationthatfluoroquinoloneantibioticsmaycausesignificantdecreasesinbloodsugarandcertainmentalhealthsideeffects.

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收录时间:2018-11-04

更新时间:2018-11-04

收录查询:www.fda.gov

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FluoroquinoloneAntibiotics:FDARequiresLabelingChangesDuetoLowBloodSugarLevelsandMentalHealthSideEffectsShareTweetLinkedinPinitMoresharingoptionsLinkedinPinitEmailPrint


[Posted07/10/2018]AUDIENCE:Patient,HealthProfessional,PharmacyISSUE:FDAisstrengtheningthecurrentwarningsintheprescribinginformationthatfluoroquinoloneantibioticsmaycausesignificantdecreasesinbloodsugarandcertainmentalhealthsideeffects.BACKGROUND:Fluoroquinoloneantibioticsareapprovedtotreatcertainseriousbacterialinfections,andhavebeenusedformorethan30years.Theyworkbykillingorstoppingthegrowthofbacteriathatcancauseillness.Withouttreatment,someinfectionscanspreadandleadtoserioushealthproblems.
Mostfluoroquinoloneantibioticdruglabelsincludeawarningthatbloodsugardisturbances,includinghighbloodsugarandlowbloodsugaranddependingonthefluoroquinoloneantibioticclass,arangeofmentalhealthsideeffectsarealreadydescribedunderCentralNervousSystemEffectsintheWarningsandPrecautionssectionofthedruglabel,whichdifferedbyindividualdrug.RECOMMENDATION:Thenewlabelchangeswilladdthatlowbloodsugarlevels,alsocalledhypoglycemia,canleadtocomaandthenewlabelwillalsomakethementalhealthsideeffectsmoreprominentandmoreconsistentacrossthesystemicfluoroquinolonedrugclass.Thementalhealthsideeffectstobeaddedtoorupdatedacrossallthefluoroquinolonesare:
disturbancesinattention
disorientation
agitation
nervousness
memoryimpairment
seriousdisturbancesinmentalabilitiescalleddelirium.
FDAcontinuestomonitorandevaluatethesafetyandeffectivenessofmedicinesafterweapprovethemandtheygoonthemarket.Inthecaseoffluoroquinolones,wereviewedreportsofcasessubmittedtoFDAandthepublishedmedicalliteratureofapparentlyhealthypatientswhoexperiencedseriouschangesinmood,behavior,andbloodsugarlevelswhilebeingtreatedwithsystemicfluoroquinolones.Patientsshouldtellyourhealthcareprofessionalsifyouaretakingadiabetesmedicinewhenyourhealthcareprofessionalisconsideringprescribinganantibiotic,andalsoifyouhavelowbloodsugarorsymptomsofitwhiletakingafluoroquinolone.Forpatientswithdiabetes,yourhealthcareprofessionalmayaskyoutocheckyourbloodsugarmoreoftenwhiletakingafluoroquinolone.Earlysignsandsymptomsoflowbloodsugarinclude:
confusion
poundingheartorveryfastpulse
dizziness
paleskin
feelingshaky
sweating
unusualhunger
tremblin