Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10182284serious1Date Last Updated30/01/2015receiptdateformat102companynumbGB-DRREDDYS-GER/UKI/14/0040429occurcountryGBduplicate1Date Received20/05/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Onset Age82Unit of Onset AgeyearsWeight40SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionMutismOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionSerotonin syndromeOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionBlepharospasmOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionMuscle rigidityOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb1drugstructuredosageunit003drugadministrationroute048drugindicationANXIETYdrugstartdateformat610drugstartdate/01/2013

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

2)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb076442drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat102drugstartdate24/03/2014drugenddateformat102drugenddate28/04/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140427

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbGB-DRREDDYS-GER/UKI/14/0040429

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use