Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10035576serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1371227occurcountryUSduplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age33Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionToxicity to various agentsOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductDIAZEPAMdrugauthorizationnumb013263drugadministrationroute065drugindicationPRODUCT 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 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

2)

drugcharacterization1medicinalproductHEROINdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization1medicinalproductOXYCODONEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id faecea25-bf41-43c2-99de-89ba81a21162, 424fa63c-5bd6-457d-b65e-c40ddfc48d6c, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

4)

drugcharacterization1medicinalproductCOCAINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

5)

drugcharacterization1medicinalproductSERTRALINEdrugadministrationroute065drugindicationPRODUCT 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

6)

drugcharacterization1medicinalproductDEXTROMETHORPHANdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA018658, part341Brand Name DELSYM, COUGH MEDICINE SOOTHING RELIEF, MIELIM Y MAS, DELSYM (DEXTROMETHORPHAN), ... Generic NameDEXTROMETHORPHANManufacturers RB Health (US) LLC, LM WHOLESALE HERBS, Efficient Laboratories Inc., RFX Pharmac ... product_ndc63824-171, 75663-002, 58593-295, 76206-002, 63824-177, 63824-173, 71598-015Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDERXCUI1373045, 1373128, 1090496, 1099285spl_id fe57fe2a-fa48-4af9-8203-9525e0d74084, a6d4e323-52ef-49d5-e053-2995a90a68ab, d90b ... spl_set_id 234e6a2c-a280-4a39-8777-9316e9d681fb, a6d4f8b7-a61e-b322-e053-2995a90a3514, 711d ... Package NDC 63824-171-63, 63824-171-65, 63824-171-75, 63824-171-22, 75663-002-10, 75663-002- ... NUIN0000181821, N0000182149, N0000181819, N0000182147Established Pharmacologic Class Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Sigma-1 Agonist [E ... Mechanism of ActionUncompetitive NMDA Receptor Antagonists [MoA], Sigma-1 Receptor Agonists [MoA]UNII7355X3ROTS, 9D2RTI9KYH

7)

drugcharacterization1medicinalproductCODEINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1371227

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use