Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033450serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1370589occurcountryUSduplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age53Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionToxicity to various agentsOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductCLONAZEPAMdrugauthorizationnumb017533drugadministrationroute048drugindicationPRODUCT 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)

drugcharacterization1medicinalproductCLONAZEPAMdrugauthorizationnumb017533drugdosagetextOVERDOSEdrugadministrationroute048

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

3)

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

4)

drugcharacterization1medicinalproductSERTRALINEdrugdosagetextOVERDOSEdrugadministrationroute048

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)

drugcharacterization1medicinalproductACETAMINOPHENdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number part343, ANDA211544, ANDA075077, ANDA076200, NDA019872, ANDA070607, ANDA207035, ... Brand Name PAIN RELIEF INFANTS, ACETAMINOPHEN, PAIN RELIEVER EXTRA STRENGTH, 8 HOUR ARTHRIT ... Generic Name ACETAMINOPHEN, ACETAMINOPHEN CAPLET, 500 MG EXTRA STRENGTH, ACETAMINOPHEN 325MG, ... Manufacturers AmerisourceBergen (Good Neighbor Pharmacy) 46122, Major Pharmaceuticals, L.N.K. ... product_ndc 46122-313, 0904-6719, 50844-519, 46122-629, 49348-430, 30142-561, 76281-526, 368 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, RECTAL, INTRAVENOUSActive Ingredients ACETAMINOPHEN, ASPIRIN, CAFFEINE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCC ... RXCUI 307668, 313782, 198440, 1148399, 828555, 313820, 198439, 307684, 798928, 1243440 ... spl_id 78b53376-2f39-493a-adf3-94ae142c8e46, 4612b5f6-4120-4364-a6f8-b43d15d0caf8, 805b ... spl_set_id 3f12331a-5509-45ec-b805-626ff11b0b80, 5483b704-88c0-4176-a04c-f8b2b85e8c57, 72ba ... Package NDC 46122-313-46, 0904-6719-50, 0904-6719-60, 0904-6719-80, 50844-519-15, 50844-519- ... UNII362O9ITL9D, R16CO5Y76E, 3G6A5W338E, 9D2RTI9KYH, V9BI9B5YI2, TC2D6JAD40NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ...

6)

drugcharacterization1medicinalproductACETAMINOPHENdrugdosagetextOVERDOSEdrugadministrationroute048

openFDA Info on Medication

Application Number part343, ANDA211544, ANDA075077, ANDA076200, NDA019872, ANDA070607, ANDA207035, ... Brand Name PAIN RELIEF INFANTS, ACETAMINOPHEN, PAIN RELIEVER EXTRA STRENGTH, 8 HOUR ARTHRIT ... Generic Name ACETAMINOPHEN, ACETAMINOPHEN CAPLET, 500 MG EXTRA STRENGTH, ACETAMINOPHEN 325MG, ... Manufacturers AmerisourceBergen (Good Neighbor Pharmacy) 46122, Major Pharmaceuticals, L.N.K. ... product_ndc 46122-313, 0904-6719, 50844-519, 46122-629, 49348-430, 30142-561, 76281-526, 368 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, RECTAL, INTRAVENOUSActive Ingredients ACETAMINOPHEN, ASPIRIN, CAFFEINE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCC ... RXCUI 307668, 313782, 198440, 1148399, 828555, 313820, 198439, 307684, 798928, 1243440 ... spl_id 78b53376-2f39-493a-adf3-94ae142c8e46, 4612b5f6-4120-4364-a6f8-b43d15d0caf8, 805b ... spl_set_id 3f12331a-5509-45ec-b805-626ff11b0b80, 5483b704-88c0-4176-a04c-f8b2b85e8c57, 72ba ... Package NDC 46122-313-46, 0904-6719-50, 0904-6719-60, 0904-6719-80, 50844-519-15, 50844-519- ... UNII362O9ITL9D, R16CO5Y76E, 3G6A5W338E, 9D2RTI9KYH, V9BI9B5YI2, TC2D6JAD40NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ...

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1370589

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use