Adverse Event Report

Report

reporttype3Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10063343serious1Date Last Updated11/02/2017receiptdateformat102companynumbUS-ACORDA-ACO_33954_2013occurcountryUSduplicate1Date Received07/04/2014seriousnesshospitalization1transmissiondate28/04/2017primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age66Unit of Onset AgeyearsWeight54.88SexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionHip fractureOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.1ReactionSluggishnessOutcomeRecovered/resolved

3)

reactionmeddraversionpt19.1ReactionHead injuryOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionGait disturbanceOutcomeUnknown

5)

reactionmeddraversionpt19.1ReactionDrug dose omissionOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionContusionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt19.1ReactionDyspnoeaOutcomeUnknown

8)

reactionmeddraversionpt19.1ReactionTherapy cessationOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionFallOutcomeUnknown

10)

reactionmeddraversionpt19.1ReactionFallOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt19.1ReactionWeight decreasedOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductCARBAMAZEPINE.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, TIDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCARBAMAZEPINE

openFDA Info on Medication

Application Number ANDA076697, ANDA070541, NDA206030, ANDA073524, ANDA211623, ANDA201106, NDA018927 ... Brand Name CARBAMAZEPINE, EPITOL, CARNEXIV, TEGRETOL, TEGRETOL XR, EQUETRO, CARBATROL, CARB ... Generic NameCARBAMAZEPINEManufacturers Nostrum Laboratories, Inc., Teva Pharmaceuticals USA, Inc., Lundbeck Pharmaceuti ... product_ndc 29033-004, 29033-019, 29033-020, 0093-0090, 67386-621, 0093-0109, 0093-0778, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCARBAMAZEPINERXCUI 200131, 200133, 388311, 211817, 308979, 2119860, 2119862, 308973, 199378, 402505 ... spl_id 9fcd6487-e123-44ca-a48f-3aa2e5858979, 2a6353f7-c318-4543-b64e-b2f58cb777dd, f2c0 ... spl_set_id fbca2152-0022-47a5-a1ea-58950b45bcbf, 32bbe864-7374-44da-8c6e-e733f0648243, fd22 ... Package NDC 29033-019-12, 29033-020-12, 29033-004-12, 0093-0090-01, 67386-621-52, 0093-0109- ... NUI N0000008486, N0000175751, N0000185506, N0000191266, N0000187064, N0000185507, N0 ... Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Established Pharmacologic ClassMood Stabilizer [EPC]Mechanism of Action Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochro ... UNII33CM23913M

2)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumb18576 OR 10576drugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext10 MG, Q 12 HRSdrugdosageformTABLETdrugadministrationroute048drugindicationGAIT DISTURBANCEdrugstartdateformat102drugstartdate17/01/2011actiondrug4

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

3)

drugcharacterization2medicinalproductTYSABRIdrugdosagetextUNK,UNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameNATALIZUMAB

openFDA Info on Medication

Application NumberBLA125104Brand NameTYSABRIGeneric NameNATALIZUMABManufacturersBiogen Inc.product_ndc64406-008Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsNATALIZUMABRXCUI477484, 603541spl_id7628d515-59db-47b7-8ba9-95dc94363af5spl_set_idc5fdde91-1989-4dd2-9129-4f3323ea2962Package NDC64406-008-01NUIN0000175775, N0000175774Established Pharmacologic ClassIntegrin Receptor Antagonist [EPC]Mechanism of ActionIntegrin Receptor Antagonists [MoA]UNII3JB47N2Q2P

4)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumb0000077314drugauthorizationnumb022250drugdosagetext10MG,QDdrugdosageformTABLETdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugenddateformat102drugenddate20/10/2015actiondrug4

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

5)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, TIDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

6)

drugcharacterization2medicinalproductDICLOFENACdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugindicationABDOMINAL DISCOMFORTdrugrecurreadministration3

activesubstance

activesubstancenameDICLOFENAC

openFDA Info on Medication

Application NumberANDA204306, ANDA206116, ANDA208077, NDA204592, ANDA203383, ANDA077845Brand NameDICLOFENAC SODIUM, DICLOFENAC, ZORVOLEXGeneric NameDICLOFENAC, DICLOFENAC SODIUMManufacturers Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, TriVue Pharmaceuticals, ... product_ndc 0378-8750, 65162-911, 65162-833, 73480-242, 59390-149, 42291-256, 17478-892, 693 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, OPHTHALMICActive IngredientsDICLOFENAC SODIUM, DICLOFENACRXCUI855633, 857700, 1442128, 854801, 1442116, 1442122, 1442130spl_id 7f7def3c-80d9-498d-8be4-d6525e81ee48, 0c5957bf-66c8-49dc-b633-dfada57bff9b, 8bfd ... spl_set_id 585549fe-dca3-47cb-a454-7a3b42fa8443, 78873f83-cea9-44d4-8ad4-8cb9257e5c7f, f64b ... Package NDC 0378-8750-06, 65162-911-74, 65162-833-66, 73480-242-90, 59390-149-02, 59390-149- ... UNIIQTG126297Q, 144O8QL0L1NUIN0000000160, N0000008836, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

7)

drugcharacterization2medicinalproductRITALINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA010187, NDA021284Brand NameRITALIN, RITALIN LAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0439, 0078-0440, 0078-0441, 0078-0370, 0078-0371, 0078-0372, 0078-0424Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI 1091150, 1091379, 1091392, 1091395, 1091497, 1091500, 1091143, 1091167, 1091182, ... spl_ida711cf71-e537-4e53-9680-4b7efb4347cb, c0d04ccb-a7f6-4d70-9b63-e6b78b425879spl_set_idc0bf0835-6a2f-4067-a158-8b86c4b0668a, effd952d-ac94-47bb-b107-589a4934dccaPackage NDC 0078-0439-05, 0078-0440-05, 0078-0441-05, 0078-0370-05, 0078-0371-05, 0078-0372- ... UNII4B3SC438HI

8)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, KLOR-CON M, POTASSIUM CHLO ... Generic NamePOTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASEManufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATIONspl_id 603fa445-ab7d-3929-e053-2a91aa0afb47, 4dca93f2-d9a9-4ecb-89d2-f67b819f82dc, ebba ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-133-10, 31722-134- ... UNII660YQ98I10, 295O53K152Application Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

9)

drugcharacterization2medicinalproductLORAZEPAM.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029 ... spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

10)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, TIDdrugindicationANXIETYdrugrecurreadministration3

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

11)

drugcharacterization2medicinalproductLASIXdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

12)

drugcharacterization2medicinalproductEPITOLdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCARBAMAZEPINE

openFDA Info on Medication

Application NumberANDA070541Brand NameEPITOLGeneric NameCARBAMAZEPINEManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0093-0090Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARBAMAZEPINERXCUI211817, 308979spl_id2a6353f7-c318-4543-b64e-b2f58cb777ddspl_set_id32bbe864-7374-44da-8c6e-e733f0648243Package NDC0093-0090-01NUI N0000008486, N0000175751, N0000185506, N0000191266, N0000187064, N0000185507, N0 ... Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Established Pharmacologic ClassMood Stabilizer [EPC]Mechanism of Action Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochro ... UNII33CM23913M

summary

narrativeincludeclinicalCASE EVENT DATE: 20121225

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_33954_2013

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use