Adverse Event Report

Report

reporttype3Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10245273serious1Date Last Updated03/03/2016receiptdateformat102companynumbUS-ACORDA-ACO_103169_2014occurcountryUSseriousnessother1duplicate1Date Received18/06/2014seriousnesshospitalization1transmissiondate25/05/2016primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification5

Patient

Weight85.26SexMale

Reaction

1)

reactionmeddraversionpt19.0ReactionHead injuryOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.0ReactionInappropriate schedule of drug administrationOutcomeUnknown

3)

reactionmeddraversionpt19.0ReactionDrug ineffectiveOutcomeUnknown

4)

reactionmeddraversionpt19.0ReactionLoss of consciousnessOutcomeRecovered/resolved

5)

reactionmeddraversionpt19.0ReactionSeizureOutcomeRecovered/resolved

6)

reactionmeddraversionpt19.0ReactionFallOutcomeRecovered/resolved

7)

reactionmeddraversionpt19.0ReactionCystitisOutcomeRecovering/resolving

8)

reactionmeddraversionpt19.0ReactionAlcohol useOutcomeRecovered/resolved

9)

reactionmeddraversionpt19.0ReactionAbasiaOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductBACLOFEN.drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate23/09/2013drugrecurreadministration3

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)

drugcharacterization2medicinalproductCOPAXONEdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate17/09/2012drugrecurreadministration3

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)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/04/2014drugrecurreadministration3

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

4)

drugcharacterization2medicinalproductOXYBUTYNINdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/01/2014drugrecurreadministration3

activesubstance

activesubstancenameOXYBUTYNIN

openFDA Info on Medication

Application NumberANDA202332, NDA021351, NDA202211Brand NameOXYBUTYNIN, OXYTROL, OXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersZydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited, Allergan, Inc.product_ndc 68382-255, 68382-256, 68382-257, 70771-1086, 70771-1087, 70771-1088, 0023-6153, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORAL, TRANSDERMALActive IngredientsOXYBUTYNIN CHLORIDE, OXYBUTYNINRXCUI863619, 863628, 863636, 403799, 404448spl_id abd28f4e-f15d-401c-8541-96bb308bf94c, 38ac4e71-8edf-4dd1-ba35-8e84006d4b48, 603f ... spl_set_id c042bf06-79a3-4dc7-ae05-3ef3cfae9d44, f405a774-bd91-4513-b7c7-c44f0596d988, 20de ... Package NDC 68382-255-06, 68382-255-14, 68382-255-16, 68382-255-01, 68382-255-05, 68382-255- ... UNIIL9F3D9RENQ, K9P6MC7092NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]

5)

drugcharacterization2medicinalproductDIURETICSdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

6)

drugcharacterization2medicinalproductVITAMIN BdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameVITAMIN B

7)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumb13M862drugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext10 MG, Q 12 HRSdrugdosageformTABLETdrugadministrationroute048drugindicationGAIT DISTURBANCEdrugstartdateformat610drugstartdate/06/2013drugenddateformat602drugenddate//2014actiondrug4

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

8)

drugcharacterization2medicinalproductMUSCLE RELAXANTSdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

9)

drugcharacterization2medicinalproductFOLIC ACID.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

10)

drugcharacterization2medicinalproductAMANTADINEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameAMANTADINE

openFDA Info on Medication

Application NumberNDA208944, ANDA214284, ANDA208966Brand NameGOCOVRI, AMANTADINEGeneric NameAMANTADINEManufacturers Adamas Pharma, LLC, Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc ... product_ndc70482-085, 70482-170, 46708-586, 62332-586, 62332-246, 46708-246Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMANTADINE, AMANTADINE HYDROCHLORIDEspl_id 67ad6dad-95d8-40bb-8024-d91a1c899b35, 48fa07c8-8b95-40d7-a0f5-132577dfb2c8, 0c54 ... spl_set_id 82ff865f-78f3-4c94-b6a9-727a54944b28, 48fa07c8-8b95-40d7-a0f5-132577dfb2c8, da18 ... Package NDC 70482-085-60, 70482-170-60, 46708-586-31, 46708-586-71, 62332-586-31, 62332-586- ... NUIN0000175543, N0000175542Established Pharmacologic ClassInfluenza A M2 Protein Inhibitor [EPC]Mechanism of ActionM2 Protein Inhibitors [MoA]UNIIBF4C9Z1J53, M6Q1EO9TD0RXCUI849395, 849389

11)

drugcharacterization2medicinalproductVITAMIN Ddrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, BIDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

12)

drugcharacterization2medicinalproductCIALISdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate19/05/2014drugrecurreadministration3

activesubstance

activesubstancenameTADALAFIL

openFDA Info on Medication

Application NumberNDA021368Brand NameCIALISGeneric NameTADALAFILManufacturersEli Lilly and Companyproduct_ndc0002-4462, 0002-4465, 0002-4463, 0002-4464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTADALAFILRXCUI402019, 402096, 402097, 403957, 404711, 484814, 757707, 762660spl_id5bb8bb3f-c4a8-499b-b9cb-c927576f0578spl_set_idbcd8f8ab-81a2-4891-83db-24a0b0e25895Package NDC 0002-4465-79, 0002-4465-34, 0002-4462-30, 0002-4462-79, 0002-4462-34, 0002-4463- ... NUIN0000175599, N0000020026Established Pharmacologic ClassPhosphodiesterase 5 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 5 Inhibitors [MoA]UNII742SXX0ICT

13)

drugcharacterization2medicinalproductANTIDEPRESSANTSdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

14)

drugcharacterization1medicinalproductAMPYRAdrugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat602drugstartdate//2014drugenddateformat610drugenddate/06/2015actiondrug4

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

15)

drugcharacterization2medicinalproductMETHOTREXATEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA040632, ANDA201529, ANDA201530, NDA008085 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Hikma Pharmac ... product_ndc 61703-350, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 0143-9830, 674 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL, SUBCUTANEOUSActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, ... spl_id 60bbb387-0ce5-4c7e-a917-5bc4b4685616, 78d0abc0-9ade-4302-ada0-72fd6d67eff9, 46c4 ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_103169_2014

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use