Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033936serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1370486occurcountryUSduplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age22Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionToxicity to various agentsOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeFatal

3)

reactionmeddraversionpt17.0ReactionCardiac arrestOutcomeFatal

4)

reactionmeddraversionpt17.0ReactionRespiratory arrestOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductDIAZEPAMdrugauthorizationnumb013263drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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 IngredientsDIAZEPAMspl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 26b3 ... 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]UNIIQ3JTX2Q7TURXCUI197589, 197590, 197591, 2120550, 801957, 801961, 801966, 309843, 309844, 309845

2)

drugcharacterization1medicinalproductACETAMINOPHEN/OXYCODONEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization1medicinalproductMETHADONEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA204166Brand NameMETHADONE HYDROCHLORIDEGeneric NameMETHADONEManufacturersVistaPharm, Inc.product_ndc66689-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHADONE HYDROCHLORIDERXCUI864706spl_id00594a6e-2875-4640-95cc-e8bcff7541bcspl_set_id4a44bde6-c348-4316-b0e0-c24b407cb823Package NDC66689-836-99UNII229809935B

4)

drugcharacterization1medicinalproductACETAMINOPHEN/HYDROCODONEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

5)

drugcharacterization1medicinalproductSERTRALINEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1370486

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use