Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID12771859primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate09/11/2016reporttype1serious2receivedateformat102Date Received22/09/2016receiptdateformat102Date Last Updated22/09/2016fulfillexpeditecriteria2companynumbUS-CELGENEUS-USA-2016094593duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-USA-2016094593

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age81Unit of Onset AgeyearsWeight86.26SexMale

Reaction

1)

reactionmeddraversionpt19.1ReactionNervousnessOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.1ReactionAstheniaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.1ReactionFatigueOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductFISH OILdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFISH OIL

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

2)

drugcharacterization2medicinalproductSERTRALINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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 f8a443ce-38d2-4184-ac36-7954fbae84d3, f35de481-61af-428e-abb4-a267238b3959, 7d81 ... 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

3)

drugcharacterization2medicinalproductPREVACIDdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_idcb972f0e-170e-4c9b-bc44-caa4b584ba4a, 7f6cc3d5-6355-48cb-b50a-958b1e96aa90spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

4)

drugcharacterization2medicinalproductDEXAMETHASONE.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

5)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbUNKNOWNdrugauthorizationnumb204026drugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat102drugstartdate14/06/2016actiondrug4drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id0e50dfc9-35ac-4b11-89f1-5c3653717c3dspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

6)

drugcharacterization2medicinalproductCENTRUM SILVERdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMINERALS\VITAMINS

7)

drugcharacterization2medicinalproductLUNESTAdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

8)

drugcharacterization2medicinalproductZOFRANdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

9)

drugcharacterization2medicinalproductTAMSULOSINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTAMSULOSIN

10)

drugcharacterization2medicinalproductTRAMADOL.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTRAMADOL

11)

drugcharacterization2medicinalproductFOLIC ACID.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Brand NameVENTRIXYL, FOLIC ACID, VENEXA, VITRAMYN, MULTITAM, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers PureTek Corporation, Leading Pharma, LLC, Amneal Pharmaceuticals of New York LLC ... product_ndc 59088-186, 69315-127, 53746-361, 10135-182, 59088-176, 71209-007, 11534-165, 586 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CALCIUM CARBONATE, CHOLECALCIFER ... spl_id c705632c-cd1a-0f43-e053-2995a90aa0b3, 92322e52-3179-4738-8c8a-14fef62311d4, ca64 ... spl_set_id c29dc729-93be-2a20-e053-2a95a90a8ca3, 1ba8c407-9613-4319-ac40-0a429cb0f3f4, fd85 ... Package NDC 59088-186-54, 69315-127-01, 69315-127-10, 53746-361-01, 53746-361-10, 10135-182- ... NUIN0000193618, M0001797, M0022797, N0000175952, M0022794, N0000175951Established Pharmacologic ClassVitamin C [EPC], Vitamin D [EPC], Vitamin B12 [EPC]Chemical StructureAscorbic Acid [CS], Vitamin D [CS], Vitamin B 12 [CS]UNII WR1WPI7EW8, PQ6CK8PD0R, H0G9379FGK, 1C6V77QF41, A150AY412V, P6YC3EG204, 935E97BO ... Application Number ANDA040796, ANDA040625, ANDA204418, ANDA202437, ANDA211064, ANDA202522, ANDA0911 ... RXCUI310410, 237786

12)

drugcharacterization2medicinalproductTERAZOSINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTERAZOSIN\TERAZOSIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075614, ANDA075317Brand NameTERAZOSINGeneric NameTERAZOSIN, TERAZOSIN HYDROCHLORIDEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Jubilant Cadista ... product_ndc 23155-735, 23155-736, 23155-737, 23155-738, 59746-383, 59746-384, 59746-385, 597 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERAZOSIN HYDROCHLORIDERXCUI260376, 313215, 313217, 313219spl_iddaad3537-a1d2-451d-ab24-3d8649ff9487, f5ff6fc2-dd2d-4f3b-8e05-ec0e952f0f21spl_set_id1dabd4d6-3023-460a-8577-08b3690e7c93, 43e92495-2cf2-46dd-a80c-f0c3c88c7b73Package NDC 23155-735-01, 23155-735-10, 23155-736-01, 23155-736-10, 23155-737-01, 23155-737- ... UNIID32S14F082

summary

narrativeincludeclinicalCASE EVENT DATE: 201608