Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10050465serious1Date Last Updated05/05/2014receiptdateformat102seriousnessdeath1companynumbUS-SA-2013SA132849occurcountryUSseriousnessother1duplicate1Date Received01/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age54Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionDepressionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPruritusOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAUBAGIOdrugbatchnumbUNKNOWNdrugauthorizationnumb202992drugstructuredosagenumb14drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCOATED TABLETdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate05/03/2013actiondrug5

openFDA Info on Medication

Application NumberNDA202992Brand NameAUBAGIOGeneric NameTERIFLUNOMIDEManufacturersGenzyme Corporationproduct_ndc58468-0210, 58468-0211Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_id00ccc1a2-a63c-418a-9f40-1792b505f2c8spl_set_id4650d12c-b9c8-4525-b07f-a2d773eca155Package NDC 58468-0211-1, 58468-0211-2, 58468-0211-4, 58468-0211-3, 58468-0210-2, 58468-0210 ... NUIN0000185502, N0000185501Established Pharmacologic ClassPyrimidine Synthesis Inhibitor [EPC]Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors [MoA]UNII1C058IKG3B

2)

drugcharacterization2medicinalproductBACLOFENdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804

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

3)

drugcharacterization2medicinalproductDETROLdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

openFDA Info on Medication

Application NumberNDA020771Brand NameDETROLGeneric NameTOLTERODINE TARTRATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-4541, 0009-4544Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOLTERODINE TARTRATERXCUI855178, 855180, 855194, 855195spl_idc3566921-d549-46b6-b227-a72daaf73ad6spl_set_id42f819c9-4108-4ca7-92c5-a213037dd4dbPackage NDC 0009-4541-02, 0009-4541-03, 0009-4541-01, 0009-4544-02, 0009-4544-03, 0009-4544- ... UNII5T619TQR3R

4)

drugcharacterization2medicinalproductNORVASCdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

5)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804

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

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-2013SA132849

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use