Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10068752serious1Date Last Updated09/04/2014receiptdateformat102companynumbGB-TEVA-471848ISRoccurcountryGBseriousnessother1duplicate1Date Received09/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification5

Patient

Onset Age35Unit of Onset AgeyearsWeight98SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionPanic attackOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionPalpitationsOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionExtrasystolesOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionHallucinationOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionChronic fatigue syndromeOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionDepressed level of consciousnessOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductAMITRIPTYLINEdrugauthorizationnumb85031drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50MG SELF TAPERING UP TO 70MGdrugadministrationroute048drugindicationNEURALGIAdrugstartdateformat102drugstartdate24/09/2013drugrecurreadministration3

2)

drugcharacterization3medicinalproductAMITRIPTYLINEdrugauthorizationnumb85031drugstructuredosagenumb70drugstructuredosageunit003drugdosagetext50MG SELF TAPERING UP TO 70MGdrugadministrationroute048drugenddateformat102drugenddate14/02/2014drugrecurreadministration3

3)

drugcharacterization3medicinalproductSERTRALINEdrugauthorizationnumb076465drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50MG INCREASED EVERY FEW WEEKS TO 150MGdrugadministrationroute048drugindicationDEPRESSED MOODdrugstartdateformat102drugstartdate22/11/2013drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

4)

drugcharacterization3medicinalproductSERTRALINEdrugauthorizationnumb076465drugstructuredosagenumb150drugstructuredosageunit003drugdosagetext50MG INCREASED EVERY FEW WEEKS TO 150MGdrugadministrationroute048drugenddateformat102drugenddate07/02/2014drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductDIAZEPAMdrugstartdateformat102drugstartdate29/01/2014drugenddateformat102drugenddate07/02/2014

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

Report Duplicate

duplicatesourceTEVAduplicatenumbGB-TEVA-471848ISR

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use