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16Aug2010:Bupivacaine(Marcain)andreportsoflackofefficacy|HSA|HealthSciencesAuthority

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16Aug2010:Bupivacaine(Marcain)andreportsoflackofefficacy

16Aug2010:Bupivacaine(Marcain)andreportsoflackof
efficacy

WesternMedicines
MedicalDevices
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Products
CosmeticProducts
ClinicalTrials

TheVigilanceBranchofHSAhasfromSeptember2009toMarch2010,receivedaclusteringofreportsonthe
lackofefficacyassociatedwiththeuseofbupivacainepreparations(Marcain0.5%andMarcainSpinal0.5%
HeavyInjection,AstraZeneca,AZ)whenusedduringspinalanaesthesia.Thisfindingledtoaseriesoffollowup
investigationstodeterminethepossiblecausesoffailedspinalanaesthesia(FSA).
MarcainSpinal0.5%HeavyInjectionandMarcain0.5%InjectionhavebeenregisteredinSingaporesinceApril
1991andJuly2006respectivelyandareindicatedfortheproductionofspinalanaesthesia.Marcain0.5%is
indicatedforlowerlimbsurgerylasting34hourswheremusclerelaxationisneededandMarcainSpinal0.5%
HeavyInjectionisindicatedforabdominalsurgerylasting4560minutesandurologicalandlowerlimbsurgery
lasting23hours.

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Localreportsoflackofefficacy

Manufacturing,Importation&
Distribution

ThreereportsoflackofefficacywithMarcainSpinal0.5%HeavyInjectionwerefirstreportedtoHSAin
September2009bydifferentanaesthetistsfromatertiaryhospital.Allthreereportswereassociatedwithasingle
batchofMarcainSpinal0.5%HeavyInjection.

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FromDecember2009toFebruary2010,sixadditionalcasesofasimilarnaturewerereported.Theseinvolvedtwo
differentbatchesofMarcainSpinalHeavy0.5%injection.

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ProductRecalls
Overview
ReportAdverseEvents
relatedtoHealthProducts
GuidelinesonProduct
DefectReportingand
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Laboratoryinvestigations
TheHSA'sPharmaceuticalLaboratoryconductedananalysisoftheaffectedbatchinvolvedinthefirstthreecases
reportedinSeptember2009.ThetestresultindicatedthatthebupivacainecontentinMarcainSpinal0.5%
HeavyInjectionwaswithinspecifications.Nonetheless,theremainingstocksofMarcainSpinal0.5%Heavy
Injectionintheaffectedbatchatthehospitalwerereturnedtothecompanyandreplacedwithanotherbatch.
FollowingtheadditionalreportsinDecember2009andearly2010,HSAcontactedhospitalpharmaciesfromboth
theprivateandpublicinstitutionstoascertainiftheyhadsimilarexperiences.Onetertiaryhospitalprovided
retrospectivereportsof13casesinvolvingbothMarcain0.5%andMarcainSpinal0.5%HeavyInjection.The
hospitalalsoprovidedampoulesofMarcain0.5%Injectionfromthesetwoaffectedbatches,whichwereassayed
byHSA'sPharmaceuticalLaboratoryandfoundtobewithinspecifications.

MedicalDeviceAlerts

AdditionaltestswereperformedbyAZtoconfirmthattheseproductscompliedwiththeregisteredspecifications.
ThedatasubmittedbyAZforqualityassessmentincludedthecertificateofanalysisofthefinishedproducts,
stabilitydataandinvestigationreports.Basedontheavailableinformation,itwasconcludedthattheanalyticaltest
resultswerewithintheregisteredproductspecificationsandthattheproductswerestableduringthespecified
shelflife.

ProductSafetyAlerts

SimilarexperienceinothercountriesandpossiblecausesofFSA

DearHealthcare
ProfessionalLetters

GlobalestimatesontheincidenceofFSArangefrom0.517%.1,2HSA'sfurtherinvestigationsalsorevealedthat
someotheragencieshadalsoencounteredsimilarpatternsofFSAinthepast.Inallofthereportedcases,there
wasnosingleidentifiablecauseandthecasesinvolvedmorethanonebatchoftheproducts.Theoutcomeof
theseinvestigationsshowedthatthecausesofFSAweremultifactorial.

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Basedonavailableliterature,thefollowingfactorsmaycontributetowardstheoccurrenceofFSA:abnormalitiesof
thespinesuchaskyphosis,scoliosis,calcificationofligaments,consequencesofosteoporosispatient's
resistancetoaspecificanaestheticlumbarinterspaceselectiondrugdosagefailedlumbarpuncturepositioning
ofthepatientandinadequateintrathecalspread.1,3,4

Conclusion
Spinalanaesthesiaisaneffectivetechniquecommonlyusedforlocalanaesthesia.Concernsaboutthequalityof
theanaestheticsmayarisewhenaclusteringofFSAoccurinthehospitalwithinashortperiodoftimefor

http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Safety_Information_and_Product_Recalls/Product_Safety_Alerts/2010/bupivacaine

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16Aug2010:Bupivacaine(Marcain)andreportsoflackofefficacy|HSA|HealthSciencesAuthority

straightforwardprocedures.
Basedontheanalysestodate,HSAhasassessedthatthecausesofFSAcouldbeacombinationofmany
factors.Aspartofitseducationalefforts,AZhasconductedtalkstohospitalstoprovidemoreinformationonthe
challengesofspinalanaesthesia,increasetheawarenessofFSAandhighlighttheimportanceofreportingsuch
casesifencounteredinthefuture.
AlthoughnonewcasesofFSAhasbeenreportedsinceMarch2010,HSAwillcontinuetomonitorthissituation
andupdatehealthcareprofessionalswhennewinformationarises.

References
1.BritishJournalofAnaesthesia2009,102(6):73948
2.EuropeanJournalofAnaesth1992,9:713
3.RegionalAnesthesia1991,16:4851
4.JClinAnesth1990SepOct,2(5):3368

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