Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10147206serious1Date Last Updated25/07/2014receiptdateformat102seriousnessdeath1companynumbUS-INCYTE CORPORATION-2014IN001139occurcountryUSseriousnessother1duplicate1Date Received01/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age70Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionCholecystitisOutcomeFatal

2)

reactionmeddraversionpt17.1ReactionPneumoniaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionVomitingOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionAbdominal discomfortOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionDyspnoea exertionalOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.1ReactionIntestinal obstructionOutcomeFatal

7)

reactionmeddraversionpt17.1ReactionMuscular weaknessOutcomeRecovering/resolving

8)

reactionmeddraversionpt17.1ReactionNauseaOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionMulti-organ failureOutcomeFatal

10)

reactionmeddraversionpt17.1ReactionPulmonary embolismOutcomeRecovering/resolving

11)

reactionmeddraversionpt17.1ReactionAstheniaOutcomeRecovering/resolving

12)

reactionmeddraversionpt17.1ReactionLeukocytosisOutcomeUnknown

13)

reactionmeddraversionpt17.1ReactionMyopathyOutcomeUnknown

14)

reactionmeddraversionpt17.1ReactionCardiac arrestOutcomeFatal

15)

reactionmeddraversionpt17.1ReactionAnaemiaOutcomeRecovering/resolving

16)

reactionmeddraversionpt17.1ReactionWhite blood cell count decreasedOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductSERTRALINE

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)

drugcharacterization2medicinalproductMORPHINE SULFATE.drugstructuredosagenumb15drugstructuredosageunit003drugdosagetext15 MG, QDdrugadministrationroute048

activesubstance

activesubstancenameMORPHINE SULFATE

openFDA Info on Medication

Application Number NDA018565, ANDA205509, NDA202515, ANDA203602, ANDA205386, ANDA074862, ANDA074769 ... Brand Name INFUMORPH 200, INFUMORPH 500, MORPHINE SULFATE, MORPHINE SULFATE EXTENDED RELEAS ... Generic NameMORPHINE SULFATEManufacturers Hikma Pharmaceuticals USA Inc., ANI Pharmaceuticals, Inc., Hospira, Inc., Novel ... product_ndc 0641-6039, 0641-6040, 62559-170, 62559-171, 0409-1890, 0409-1891, 0409-1892, 040 ... Product TypeHUMAN PRESCRIPTION DRUGRouteEPIDURAL, INTRATHECAL, ORAL, INTRAVENOUS, INTRAMUSCULAR, RECTALActive IngredientsMORPHINE SULFATERXCUI 892652, 1731522, 1731998, 1731999, 892589, 894780, 998212, 1729197, 891874, 8918 ... spl_id 8547ce00-50df-4f64-8960-478e1f72663f, da0b62f3-1a22-4730-ae16-b6d0830c5024, 4442 ... spl_set_id db9ac9e3-d761-4a99-9f34-4946ebe8f255, 6cef9808-d867-4908-964b-c57ce500dccc, c8d4 ... Package NDC 0641-6039-01, 0641-6040-01, 62559-170-01, 62559-170-05, 62559-171-01, 62559-171- ... UNIIX3P646A2J0

3)

drugcharacterization2medicinalproductASPIRIN.

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

4)

drugcharacterization2medicinalproductLEVOTHYROXINE

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

5)

drugcharacterization2medicinalproductPRAVASTATIN

activesubstance

activesubstancenamePRAVASTATIN\PRAVASTATIN SODIUM

6)

drugcharacterization1medicinalproductJAKAFIdrugbatchnumbNOT AVAILABLEdrugauthorizationnumb202192drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationMYELOPROLIFERATIVE DISORDERdrugstartdateformat102drugstartdate08/03/2014actiondrug4

activesubstance

activesubstancenameRUXOLITINIB

openFDA Info on Medication

Application NumberNDA202192Brand NameJAKAFIGeneric NameRUXOLITINIBManufacturersIncyte Corporationproduct_ndc50881-005, 50881-010, 50881-015, 50881-020, 50881-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRUXOLITINIBRXCUI 1193331, 1193337, 1193339, 1193341, 1193343, 1193345, 1193347, 1193349, 1193351, ... spl_id1cf98918-4377-4b1b-8b2f-1ae23681d1d2spl_set_idf1c82580-87ae-11e0-bc84-0002a5d5c51bPackage NDC 50881-005-60, 50881-010-01, 50881-010-60, 50881-015-60, 50881-020-60, 50881-025- ... NUIN0000175605, N0000175076Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionProtein Kinase Inhibitors [MoA]UNII82S8X8XX8H

7)

drugcharacterization2medicinalproductEFFIENTdrugindicationSTENT PLACEMENTactiondrug1

activesubstance

activesubstancenamePRASUGREL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022307Brand NameEFFIENTGeneric NamePRASUGREL HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-5121, 0002-5123Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRASUGREL HYDROCHLORIDERXCUI855812, 855816, 855818, 855820spl_id165f7b4d-c0c0-4829-876e-1412e14d441dspl_set_id5fe9c118-c44b-48d7-a142-9668ae3df0c6Package NDC 0002-5121-30, 0002-5121-01, 0002-5121-52, 0002-5123-30, 0002-5123-01, 0002-5123- ... UNIIG89JQ59I13

8)

drugcharacterization2medicinalproductPOTASSIUM

activesubstance

activesubstancenamePOTASSIUM

9)

drugcharacterization2medicinalproductXARELTO

activesubstance

activesubstancenameRIVAROXABAN

openFDA Info on Medication

Application NumberNDA202439, NDA022406Brand NameXARELTOGeneric NameRIVAROXABANManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-577, 50458-580, 50458-578, 50458-579, 50458-584Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIVAROXABANRXCUI 1114198, 1114202, 1232082, 1232084, 1232086, 1232088, 1549682, 1549683, 2059015, ... spl_idbc8e9efa-638a-11ea-9dc6-12fbfb2ca371spl_set_id10db92f9-2300-4a80-836b-673e1ae91610Package NDC 50458-577-60, 50458-577-18, 50458-577-14, 50458-577-01, 50458-577-10, 50458-580- ... NUIN0000175635, N0000175637Mechanism of ActionFactor Xa Inhibitors [MoA]Established Pharmacologic ClassFactor Xa Inhibitor [EPC]UNII9NDF7JZ4M3

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceINCYTEduplicatenumbUS-INCYTE CORPORATION-2014IN001139

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use