Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10112350serious1Date Last Updated28/01/2015receiptdateformat102companynumbCA-ABBVIE-14P-028-1227086-00occurcountryCAseriousnessother1duplicate1Date Received25/04/2014transmissiondate20/07/2015primarysourcecountryCA

Primary Source

reportercountryCAqualification3

Patient

Onset Age38Unit of Onset AgeyearsWeight63SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionCondition aggravatedOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionDysthymic disorderOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionHypersensitivityOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionPsoriatic arthropathyOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductLEVOTHYROXINEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

2)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute058drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameADALIMUMAB

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

3)

drugcharacterization2medicinalproductNORGESTIMATE AND ETHINYL ESTRADIOLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameETHINYL ESTRADIOL\NORGESTIMATE

openFDA Info on Medication

Application Number ANDA090793, NDA019697, NDA019653, ANDA090523, ANDA205441, ANDA091232, ANDA090524 ... Brand Name TRI-ESTARYLLA, ORTHO TRI CYCLEN, ORTHO CYCLEN, MONO-LINYAH, TRI-MILI, NORGESTIMA ... Generic NameNORGESTIMATE AND ETHINYL ESTRADIOLManufacturers Xiromed, LLC., Janssen Pharmaceuticals, Inc., Northstar Rx LLC, Aurobindo Pharma ... product_ndc 70700-121, 50458-191, 50458-197, 16714-360, 65862-777, 42291-565, 16714-363, 422 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 240128, 406396, 687424, 748797, 749784, 1369770, 749785, 749860, 749861, 1365899 ... spl_id 0a7030cb-f7d3-6466-03ca-10c6529bba26, a5100f0c-d6a0-4340-91ab-04bb630476cb, acf5 ... spl_set_id 1ba8a8ab-eb09-0807-47d4-6b4055d10d91, 384e7a40-dcbd-4908-bf5e-65abc9932973, 84a2 ... Package NDC 70700-121-84, 70700-121-85, 50458-191-00, 50458-191-15, 50458-191-20, 50458-191- ... RouteORAL

4)

drugcharacterization2medicinalproductTRAMADOL AND ACETAMINOPHENdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\TRAMADOL HYDROCHLORIDE

5)

drugcharacterization2medicinalproductSERTRALINEdrugindicationPRODUCT 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 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

6)

drugcharacterization1medicinalproductENBRELdrugbatchnumbUNKNOWNdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute058drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug4

activesubstance

activesubstancenameETANERCEPT

openFDA Info on Medication

Application NumberBLA103795Brand NameENBRELGeneric NameETANERCEPTManufacturersImmunex Corporationproduct_ndc 58406-010, 58406-435, 58406-445, 58406-425, 58406-455, 58406-456, 58406-446, 584 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsETANERCEPTRXCUI 253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 21823 ... spl_id2ba5b73d-d161-42a8-94d1-2bdd101b2e98spl_set_ida002b40c-097d-47a5-957f-7a7b1807af7fPackage NDC 58406-435-01, 58406-435-04, 58406-445-01, 58406-445-04, 58406-425-41, 58406-425- ... NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIOP401G7OJC

7)

drugcharacterization2medicinalproductCELEBREXdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

Report Duplicate

duplicatesourceABBVIEduplicatenumbCA-ABBVIE-14P-028-1227086-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use