Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10082877serious1Date Last Updated30/04/2014receiptdateformat102companynumbUS-TAKEDA-2014TUS002865occurcountryUSseriousnessother1duplicate1Date Received16/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age36Unit of Onset AgeyearsWeight115.65SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionSuicide attemptOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionOverdoseOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductBRINTELLIXdrugauthorizationnumb204447drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb150drugcumulativedosageunit003drugdosagetext10 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationMAJOR DEPRESSIONdrugstartdateformat102drugstartdate11/02/2014drugenddateformat102drugenddate25/02/2014actiondrug1

2)

drugcharacterization2medicinalproductEFFEXORdrugadministrationroute048drugindicationMAJOR DEPRESSIONactiondrug5

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id0a5ea9cc-56af-4474-a69e-443eed935fc8spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

3)

drugcharacterization2medicinalproductVICODINdrugadministrationroute048actiondrug5

4)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QDdrugadministrationroute048drugindicationMAJOR DEPRESSIONdrugstartdateformat610drugstartdate/12/2013actiondrug4

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductCOUMADIN /00014802/drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QD SINCE FEW YEARSdrugadministrationroute048drugindicationPULMONARY EMBOLISMactiondrug5

6)

drugcharacterization2medicinalproductBACLOFENdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, TID SINCE FEW YEARSdrugadministrationroute048drugindicationBACK PAINactiondrug5

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

7)

drugcharacterization2medicinalproductOXYCONTINdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, BIDdrugadministrationroute048drugindicationBACK PAINactiondrug5

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id21ec1aed-af99-6d71-bc44-4755651ecd9espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

Report Duplicate

duplicatesourceTAKEDAduplicatenumbUS-TAKEDA-2014TUS002865

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use