Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10186865serious1Date Last Updated04/07/2014receiptdateformat102companynumb2014SP002804occurcountryUSduplicate1Date Received22/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age39Unit of Onset AgeyearsWeight67.1SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionBlood albumin decreased

2)

reactionmeddraversionpt17.1ReactionBlood alkaline phosphatase increased

3)

reactionmeddraversionpt17.1ReactionBlood bilirubin increased

4)

reactionmeddraversionpt17.1ReactionMetastases to central nervous system

5)

reactionmeddraversionpt17.1ReactionHeadacheOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.1ReactionHaemoglobin decreased

7)

reactionmeddraversionpt17.1ReactionBlood sodium decreased

8)

reactionmeddraversionpt17.1ReactionLymphocyte count decreased

9)

reactionmeddraversionpt17.1ReactionSyncopeOutcomeRecovered/resolved

10)

reactionmeddraversionpt17.1ReactionDehydrationOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.1ReactionWhite blood cell count decreased

12)

reactionmeddraversionpt17.1ReactionBlood glucose increased

13)

reactionmeddraversionpt17.1ReactionPlatelet count decreased

Drug

1)

drugcharacterization1medicinalproductDOXORUBICINdrugauthorizationnumb200170drugstructuredosagenumb75drugstructuredosageunit009drugcumulativedosagenumb138drugcumulativedosageunit003drugdosageformSOLUTION FOR INFUSIONdrugadministrationroute040drugindicationSOFT TISSUE NEOPLASMdrugstartdateformat102drugstartdate26/02/2014drugenddateformat102drugenddate26/02/2014actiondrug4

activesubstance

activesubstancenameDOXORUBICIN

openFDA Info on Medication

Application NumberANDA208888Brand NameDOXORUBICIN HYDROCHLORIDEGeneric NameDOXORUBICINManufacturersAmneal Pharmaceuticals LLCproduct_ndc70121-1218, 70121-1219Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsDOXORUBICIN HYDROCHLORIDERXCUI1790095, 1872062spl_idb157a787-7f38-4e47-9c0b-c3ee3977b1ddspl_set_idd928625e-c1ef-4f25-8d25-764c8c6aab67Package NDC70121-1218-1, 70121-1218-7, 70121-1219-1UNII82F2G7BL4E

2)

drugcharacterization1medicinalproductDOXORUBICINdrugauthorizationnumb200170drugcumulativedosagenumb138drugcumulativedosageunit003drugdosageformSOLUTION FOR INFUSIONdrugindicationSOFT TISSUE NEOPLASMdrugstartdateformat102drugstartdate14/11/2013actiondrug4

activesubstance

activesubstancenameDOXORUBICIN

openFDA Info on Medication

Application NumberANDA208888Brand NameDOXORUBICIN HYDROCHLORIDEGeneric NameDOXORUBICINManufacturersAmneal Pharmaceuticals LLCproduct_ndc70121-1218, 70121-1219Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsDOXORUBICIN HYDROCHLORIDERXCUI1790095, 1872062spl_idb157a787-7f38-4e47-9c0b-c3ee3977b1ddspl_set_idd928625e-c1ef-4f25-8d25-764c8c6aab67Package NDC70121-1218-1, 70121-1218-7, 70121-1219-1UNII82F2G7BL4E

3)

drugcharacterization2medicinalproductONDANSETRONdrugstartdateformat102drugstartdate14/11/2013drugenddateformat102drugenddate26/02/2014

activesubstance

activesubstancenameONDANSETRON

openFDA Info on Medication

Application Number ANDA206846, ANDA079224, ANDA090648, ANDA078776, ANDA077851, ANDA076972, ANDA0769 ... Brand NameONDANSETRON, ZUPLENZ, ONDANSETRON HYDROCHLORIDEGeneric NameONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON TABLETSManufacturers Accord Healthcare, Inc., Heritage Pharmaceuticals, NorthStar Rx LLC, Eywa Pharma ... product_ndc 16729-298, 23155-547, 23155-549, 16714-671, 71930-017, 71930-018, 45963-538, 459 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsONDANSETRON, ONDANSETRON HYDROCHLORIDERXCUI 283504, 1740467, 312085, 198052, 312086, 998028, 998032, 998033, 998035, 104894, ... spl_id 58fbdc1b-69f5-58f3-e053-2991aa0a1a04, 4503b017-b020-41e2-b0e1-6602dc7e28f2, f821 ... spl_set_id 35e0d160-813f-41d7-a382-d2cab6485d9c, b746d4db-43e6-4219-9e6b-f53e59581305, ac3d ... Package NDC 16729-298-05, 23155-547-31, 23155-547-41, 23155-547-42, 23155-549-31, 16714-671- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNII4AF302ESOS, NMH84OZK2B

4)

drugcharacterization2medicinalproductPEGFILGRASTIMdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014

activesubstance

activesubstancenamePEGFILGRASTIM

openFDA Info on Medication

Application NumberBLA761075, BLA125031Brand NameFULPHILA, NEULASTAGeneric NamePEGFILGRASTIMManufacturersMylan Institutional LLC, Amgen Incproduct_ndc67457-833, 55513-190, 55513-192Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGFILGRASTIMRXCUI2048020, 2048025, 727539, 727542spl_idde8859d8-8a2a-4fb3-8c22-d7235a2e37db, 5a2e5ec4-0727-4207-b5c3-251d9c3b3fdbspl_set_id3ea915d7-2feb-4e75-91f7-913c965b7d8a, fdfe5d72-6b80-435a-afa4-c5d74dd852cePackage NDC67457-833-06, 55513-192-01, 55513-190-01NUIM0024696, M0024695, N0000009451, N0000175666Chemical Structure Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimul ... Physiologic/Pharmacodynamic EffectIncreased Myeloid Cell Production [PE]Established Pharmacologic ClassLeukocyte Growth Factor [EPC]UNII3A58010674

5)

drugcharacterization2medicinalproductLORAZEPAM.drugstartdateformat102drugstartdate14/11/2013

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 IngredientsLORAZEPAMRXCUI238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029spl_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

6)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstartdateformat102drugstartdate14/11/2013drugenddateformat102drugenddate03/03/2014

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, NDA211379, ANDA201270, ANDA088481, ANDA088254, NDA208912, ... Brand Name OZURDEX, TAPERDEX 12-DAY, HEMADY, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Acrotech Biopharma LLC, Levins Pharmaceutica ... product_ndc 0023-3348, 42195-149, 42195-490, 72893-015, 71905-400, 48102-045, 48102-046, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 2261802, 2286261, 2121587, 197577, 197 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, dff2b4b8-6dba-4bf3-ac9d-3960db623d1b, 20ec ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, aec6 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 72893-015-24, 72893-015- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

7)

drugcharacterization2medicinalproductPROCHLORPERAZINE.drugstartdateformat102drugstartdate14/11/2013

activesubstance

activesubstancenamePROCHLORPERAZINE

openFDA Info on Medication

Application NumberANDA040058, ANDA040246Brand NamePROCHLORPERAZINE, COMPROGeneric NamePROCHLORPERAZINEManufacturersCosette Pharmaceuticals, Inc., Paddock Laboratories, LLCproduct_ndc0713-0135, 0574-7226Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsPROCHLORPERAZINERXCUI198159, 284254spl_idca1e6e40-c2e6-46a6-ad10-6a881d91e1e3, 9fece974-eb12-49e0-8975-97b0b9a1b27cspl_set_id9595346e-76e5-e155-341b-ffaaafb885ab, ea381bc5-0957-4c91-826a-0ff680cebaccPackage NDC0713-0135-12, 0713-0135-10, 0574-7226-12NUIN0000175746, M0016525Established Pharmacologic ClassPhenothiazine [EPC]Chemical StructurePhenothiazines [CS]UNIIYHP6YLT61T

8)

drugcharacterization2medicinalproductIBUPROFEN SODIUMdrugstartdateformat102drugstartdate18/12/2013

activesubstance

activesubstancenameIBUPROFEN SODIUM

openFDA Info on Medication

Application NumberNDA201803, ANDA206581Brand NameADVIL, ADVIL MENSTRUAL PAIN, IBUPROFEN SODIUMGeneric NameIBUPROFEN SODIUM, IBUPROFENManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Walgreen Companyproduct_ndc0573-0133, 0573-0134, 0573-0230, 0363-0909Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN SODIUMRXCUI153008, 310965spl_id fc3f9fd1-0569-4374-bcc4-bdbdbcb5411b, dfffa4a7-70e5-4ff7-a40b-2b0df385ea30, 5dad ... spl_set_id 5be198b8-396e-4b44-8819-e2e3b5d2ad0e, ae1625f4-ef32-4d4f-bf54-c44085843e41, f2a3 ... Package NDC 0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133- ... UNIIRM1CE97Z4N

9)

drugcharacterization2medicinalproductALPRAZOLAM.drugstartdateformat602drugstartdate//2013

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

10)

drugcharacterization2medicinalproductSERTRALINEdrugstartdateformat602drugstartdate//2013

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: 20140305

Report Duplicate

duplicatesourceSTRIDESduplicatenumb2014SP002804

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use