Adverse Event Report

Report

reporttype1Version of Safety Report ID8receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10370082serious1Date Last Updated19/12/2014receiptdateformat102companynumbGB-DRREDDYS-GER/UKI/14/0042224occurcountryGBduplicate1Date Received08/08/2014seriousnesshospitalization1transmissiondate28/05/2015primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age78Unit of Onset AgeyearsWeight65.31SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionHaematoma

2)

reactionmeddraversionpt18.0ReactionDrug interactionOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionHaemorrhageOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionAcute kidney injuryOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionCerebrovascular accidentOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionBlood pressure decreased

7)

reactionmeddraversionpt18.0ReactionHaemoglobin decreased

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb076442drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat102drugenddate23/01/2014actiondrug5drugrecurreadministration3

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

2)

drugcharacterization3medicinalproductCALCIPARINEdrugstructuredosagenumb25000drugstructuredosageunit025drugadministrationroute041drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate28/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameHEPARIN CALCIUM

3)

drugcharacterization3medicinalproductSINTROMdrugindicationATRIAL FIBRILLATIONdrugenddateformat102drugenddate20/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameACENOCOUMAROL

4)

drugcharacterization1medicinalproductCRESTORdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-0751, 0310-0755, 0310-0752, 0310-0754Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id0abd2d1e-ee9a-4738-ad7e-610a2caa24abspl_set_idbb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-0755-90, 0310-0751-90, 0310-0751-39, 0310-0752-90, 0310-0752-39, 0310-0754- ... UNII83MVU38M7Q

5)

drugcharacterization3medicinalproductCO-DIOVANdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationHYPERTENSIONactiondrug4drugrecurreadministration3

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\VALSARTAN

6)

drugcharacterization3medicinalproductSINTROMdrugstartdateformat102drugstartdate25/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameACENOCOUMAROL

7)

drugcharacterization3medicinalproductCLEXANEdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute058drugindicationATRIAL FIBRILLATIONdrugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameENOXAPARIN SODIUM

8)

drugcharacterization3medicinalproductIBUPROFEN.drugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPAINdrugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate30/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

9)

drugcharacterization3medicinalproductASPIRIN.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationCORONARY ARTERY DISEASEactiondrug4drugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

summary

narrativeincludeclinicalCASE EVENT DATE: 201401

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbGB-DRREDDYS-GER/UKI/14/0042224

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use