Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10034457serious1Date Last Updated25/03/2014receiptdateformat102seriousnessdeath1companynumbUS-ROCHE-1370579occurcountryUSduplicate1Date 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)

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)

drugcharacterization1medicinalproductMORPHINEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

3)

drugcharacterization1medicinalproductOXYCODONEdrugadministrationroute048drugindicationPRODUCT 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)

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)

drugcharacterization1medicinalproductETHANOLdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Numberpart333A, part333EBrand Name ELYPTOL LIGHT SCENT- ANTIMICROBIAL HAND GEL, ELYPTOL ANTIMICROBIAL RUB, CANPACO ... Generic NameETHANOL, ALCOHOL, 95%ETHANOLManufacturers ELYPTOL INC., Elyptol Inc., HEALKINBIO CO., Magnus Procurement & Logistics Solut ... product_ndc 69343-421, 69343-221, 76586-109, 81122-139, 81441-005, 75708-7502, 79268-001, 73 ... Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsALCOHOL, CHLORPHENESIN, PHENOXYETHANOLRXCUI 581662, 582753, 581660, 616805, 1305100, 1039339, 2286291, 1812262, 1041849, 581 ... spl_id e3ab7e18-7a60-4d3c-aedd-4759716cd1c0, d58dc4c4-e132-40b7-8cd3-93c184cc4a4a, a7da ... spl_set_id 3d148ce6-e6ac-4baa-937a-cce49de182a5, a6903410-ab88-4634-9937-4b2d00e07915, a7da ... Package NDC 69343-421-02, 69343-421-08, 69343-421-16, 69343-421-32, 69343-421-01, 69343-421- ... UNII3K9958V90M, I670DAL4SZ, HIE492ZZ3T

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1370579

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use