Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10034808serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1371380occurcountryUSduplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age58Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionToxicity to various agentsOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductCLONAZEPAMdrugauthorizationnumb017533drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

2)

drugcharacterization1medicinalproductHEROINdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization1medicinalproductCOCAINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

4)

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

5)

drugcharacterization1medicinalproductVENLAFAXINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA211323, ANDA079098, ANDA206250, ANDA078627, ANDA078932, ANDA090555, ANDA0776 ... Brand NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEGeneric NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEManufacturers Cadila Pharmaceuticals Limited, Amneal Pharmaceuticals LLC, Sun Pharmaceutical I ... product_ndc 71209-087, 71209-088, 71209-089, 65162-300, 65162-302, 65162-306, 65162-307, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI808744, 808748, 808753, 313580, 313582, 313584, 313586, 314277, 808751spl_id f0cda912-3f9e-4f18-a55e-a5cc80bd2e7a, 11f387e7-a398-4a1f-90d8-7454e9bd499d, a3b2 ... spl_set_id 516e7566-35c2-4a25-88d8-54d9dbc8f6be, 62c02cdb-ea65-41ff-a531-4d9ea498f705, 2ed6 ... Package NDC 71209-087-01, 71209-087-04, 71209-087-11, 71209-088-01, 71209-088-04, 71209-088- ... UNII7D7RX5A8MO

6)

drugcharacterization1medicinalproductQUININEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameCHININUM PURUM, QUININE SULFATEGeneric NameQUININEManufacturersWashington Homeopathic Products, Amneal Pharmaceuticals LLCproduct_ndc68428-308, 71919-187, 65162-811Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUININE, QUININE SULFATEspl_id b6f1f97f-52bf-704e-e053-2a95a90a174f, 7e466369-53c3-7a05-e053-2991aa0a4eee, 7702 ... spl_set_id 637ffcac-7484-4067-8ba6-2f36ae14b7da, eed4f0bd-7dd8-4515-91c7-91d2db6967e4, f567 ... Package NDC 68428-308-03, 68428-308-05, 68428-308-11, 68428-308-12, 68428-308-06, 71919-187- ... NUIN0000175482Established Pharmacologic ClassAntimalarial [EPC]UNIIA7V27PHC7A, KF7Z0E0Q2BApplication NumberANDA203729RXCUI997010

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1371380

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use