Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10034485serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1370581occurcountryUSduplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age52Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionToxicity to various agentsOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeFatal

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)

drugcharacterization1medicinalproductTRAMADOLdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization1medicinalproductACETAMINOPHEN/HYDROCODONEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

4)

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

5)

drugcharacterization1medicinalproductCYCLOBENZAPRINEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA090478, ANDA071611Brand NameCYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINEGeneric NameCYCLOBENZAPRINE, CYCLOBENZAPRINE HYDROCHLORIDEManufacturersCipla USA Inc., Rising Health, LLCproduct_ndc69097-845, 69097-846, 57237-266Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCYCLOBENZAPRINE HYDROCHLORIDERXCUI828320, 828348, 828299spl_idfb272847-c855-4abb-b9dd-0d7a4b92bef0, 09330886-13f8-44cc-98d2-883f3e0514b4spl_set_id575a31fb-04c5-4001-88a7-c33adbacc6a8, b12fb4ea-182e-462b-b6ed-cfd2f6bb71e8Package NDC69097-845-07, 69097-845-15, 69097-846-07, 69097-846-15, 57237-266-01UNII0VE05JYS2P

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1370581

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use