Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033921serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1370612occurcountryUSduplicate1Date 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)

drugcharacterization1medicinalproductMETHADONEdrugadministrationroute065drugindicationPRODUCT 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

3)

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

4)

drugcharacterization1medicinalproductAMPHETAMINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA211139, NDA208147, ANDA213763, NDA204325, ANDA212919, NDA204326Brand Name AMPHETAMINE SULFATE, DYANAVEL XR, ADZENYS ER, ADZENYS XR-ODT, AMPHETAMINE EXTEND ... Generic NameAMPHETAMINEManufacturers Amneal Pharmaceuticals NY LLC, Tris Pharma Inc, Ingenus Pharmaceuticals, LLC, Ne ... product_ndc 69238-1563, 69238-1564, 27808-102, 50742-652, 50742-651, 70165-003, 69452-227, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMPHETAMINE SULFATE, AMPHETAMINERXCUI 884655, 1600695, 1720586, 1720592, 1945840, 1945844, 1739803, 1739809, 1739813, ... spl_id d8b116d9-3a75-4f4b-affd-47a2e7928867, 00548fef-2ddb-4860-9bd0-fc88e2ae759c, c9e9 ... spl_set_id 53d40847-e0d3-48ec-81a7-ec5478553565, a8a7eb93-4192-4826-bbf1-82c06634f553, 8c2a ... Package NDC 69238-1563-1, 69238-1564-1, 27808-102-01, 50742-651-01, 50742-652-01, 70165-003- ... UNII6DPV8NK46S, CK833KGX7ENUIN0000175739, N0000175729Established Pharmacologic ClassCentral Nervous System Stimulant [EPC]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1370612

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use