Adverse Event Report

Report

reporttype3Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10085055serious1Date Last Updated22/06/2015receiptdateformat102seriousnessdeath1companynumbUS-ACORDA-ACO_102866_2014occurcountryUSseriousnessother1duplicate1Date Received17/04/2014transmissiondate21/08/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age76Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionMyocardial infarctionOutcomeFatal

Drug

1)

drugcharacterization2medicinalproductBACLOFEN.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameBACLOFEN

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

2)

drugcharacterization2medicinalproductCOPAXONEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameGLATIRAMER ACETATE

openFDA Info on Medication

Application NumberNDA020622Brand NameCOPAXONEGeneric NameGLATIRAMER ACETATEManufacturersTeva Neuroscience, Inc.product_ndc68546-317, 68546-325Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsGLATIRAMER ACETATERXCUI1111641, 1111642, 1487361, 1487363spl_idbea8ff63-1eaf-4d40-a913-dafabf9f0c63spl_set_idaa88f583-4f5f-433b-80b4-1f4c9fb28357Package NDC68546-317-00, 68546-317-30, 68546-325-06, 68546-325-12UNII5M691HL4BO

3)

drugcharacterization2medicinalproductLECITHINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

4)

drugcharacterization2medicinalproductREQUIPdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameROPINIROLE HYDROCHLORIDE

5)

drugcharacterization2medicinalproductFISH OILdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

6)

drugcharacterization2medicinalproductFLOMAXdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameTAMSULOSIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020579Brand NameFLOMAXGeneric NameTAMSULOSIN HYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc., sanofi-aventis U.S. LLCproduct_ndc0597-0058, 0024-5837Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTAMSULOSIN HYDROCHLORIDERXCUI863669, 863671spl_id0bb39eda-fe6f-e454-727f-1ba3cbf9cf4d, db1b29b8-fb5c-42ff-a093-cc5001e6ad6fspl_set_idc00d5f7b-dad7-4479-aae2-fea7c0db40ed, 6771ad8e-ac92-4aec-b484-5d8350a353f8Package NDC0597-0058-01, 0024-5837-01UNII11SV1951MR

7)

drugcharacterization2medicinalproductMULTIVITAMINdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameVITAMINS

8)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

9)

drugcharacterization1medicinalproductAMPYRAdrugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat610drugstartdate/09/2010drugenddateformat610drugenddate/10/2010actiondrug5

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_id99d8ffc6-164d-b055-e053-2995a90ad0c9spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

10)

drugcharacterization2medicinalproductCALCIUMdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCALCIUM

openFDA Info on Medication

Brand Name P D ALL, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, TALL G U, C P RE, D T B ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd.product_ndc 81445-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 81445-0008, 81445-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id b9e7d910-8df8-ca9a-e053-2995a90a0d05, b9eb3dea-4f3e-1d23-e053-2995a90a4eb2, b9eb ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, b9eb3cc9-e340-c77d-e053-2995a90a1628, b9eb ... Package NDC 81445-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001-1, 81445-0008 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

summary

narrativeincludeclinicalCASE EVENT DATE: 2010

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_102866_2014

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use