Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10762478primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype3serious2receivedateformat102Date Received04/02/2015receiptdateformat102Date Last Updated04/02/2015fulfillexpeditecriteria2companynumbUS-ACORDA-ACO_102591_2014duplicate1

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_102591_2014

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age55Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionArthropathyOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionArthralgiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionGait disturbanceOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

2)

drugcharacterization2medicinalproductMAGNESIUM OXIDE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMAGNESIUM OXIDE

openFDA Info on Medication

Application Numberpart331Brand NameMAGNESIUM OXIDE, ANTACIDGeneric NameMAGNESIUM OXIDEManufacturers Westminster Pharmaceuticals, LLC, PAR Pharmaceuticals, Marlex Pharmaceuticals In ... product_ndc 69367-298, 0603-0209, 10135-721, 58657-120, 54738-973, 68210-4171, 0603-0213, 54 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUM OXIDERXCUI198741, 311430spl_id 5501dfcf-df9c-4b51-9722-b7e78076cd6f, 6dae00c5-fb60-4bb5-b278-d38ff3d1068c, dde2 ... spl_set_id 52eeac0e-94bb-48c3-81dc-578e96406c01, d3c5b01b-f0d6-4503-ab18-b1a72386e2c6, dc57 ... Package NDC 69367-298-20, 0603-0209-22, 10135-721-01, 58657-120-12, 54738-973-12, 68210-4171 ... UNII3A3U0GI71G

3)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

4)

drugcharacterization2medicinalproductVALIUMdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2014drugrecurreadministration3

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc., Waylis Therapuetics LLCproduct_ndc0140-0004, 0140-0005, 0140-0006, 80725-004, 80725-005, 80725-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMRXCUI104699, 104700, 104701, 197589, 197590, 197591spl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14, dc250376-39ef-2207-e053-2a95a90a4901spl_set_id554baee5-b171-4452-a50a-41a0946f956c, 260e2041-2bb3-482f-850e-b5d47a7bdbe6Package NDC 0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14, 80725-004- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

5)

drugcharacterization2medicinalproductSEROQUELdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2014drugrecurreadministration3

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294, 37cb4cbf-8192-4921-b17c-e562467fc018spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

6)

drugcharacterization2medicinalproductWELLBUTRIN XLdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515Brand NameWELLBUTRIN XLGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLCproduct_ndc0187-0730, 0187-0731Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21Package NDC0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07UNIIZG7E5POY8O

7)

drugcharacterization2medicinalproductNEXIUMdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

8)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumb13J542drugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationGAIT DISTURBANCEdrugstartdateformat610drugstartdate/03/2014actiondrug4

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_idd17992b6-a426-7196-e053-2a95a90a8282spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

9)

drugcharacterization2medicinalproductMETFORMINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

10)

drugcharacterization2medicinalproductPROZACdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_ida99ea01f-e367-47b8-b25c-8f554314c534spl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

summary

narrativeincludeclinicalCASE EVENT DATE: 20140317