Adverse Event Report

Report

reporttype1Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10170553serious1Date Last Updated24/07/2014receiptdateformat102seriousnessdeath1companynumbPHEH2014US009702occurcountryUSduplicate1Date Received13/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age54Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionSudden deathOutcomeFatal

2)

reactionmeddraversionpt17.1ReactionDiabetes mellitus inadequate controlOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionSalivary hypersecretionOutcomeFatal

4)

reactionmeddraversionpt17.1ReactionCyanosisOutcomeFatal

5)

reactionmeddraversionpt17.1ReactionMyocardial infarctionOutcomeFatal

6)

reactionmeddraversionpt17.1ReactionChest painOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductGILENYAdrugauthorizationnumb022527drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat610drugstartdate/11/2012actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameFINGOLIMOD HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022527Brand NameGILENYAGeneric NameFINGOLIMOD HCLManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0607, 0078-0965Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINGOLIMOD HYDROCHLORIDERXCUI1012895, 1012899, 2045491, 2045493spl_idf4110640-5d3d-4957-83e2-71a0c7b71bd2spl_set_idcc9e1c8c-0e2b-44e2-878b-27057f786be9Package NDC0078-0607-15, 0078-0607-51, 0078-0607-89, 0078-0965-89UNIIG926EC510T

2)

drugcharacterization2medicinalproductOXYCODONEdrugindicationBACK PAINactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameOXYCODONE

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id faecea25-bf41-43c2-99de-89ba81a21162, 424fa63c-5bd6-457d-b65e-c40ddfc48d6c, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

3)

drugcharacterization2medicinalproductTRAMADOLdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTRAMADOL

4)

drugcharacterization2medicinalproductPREGABALIN.drugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application Number ANDA209357, ANDA206912, NDA209501, ANDA203459, ANDA212865, ANDA091157, ANDA20762 ... Brand NamePREGABALIN, LYRICA CR, LYRICAGeneric NamePREGABALINManufacturers MSN LABORATORIES PRIVATE LIMITED, Camber Pharmaceuticals, Inc., Parke-Davis Div ... product_ndc 69539-011, 69539-012, 69539-013, 69539-014, 69539-015, 69539-016, 69539-017, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 1988974, 1988977 ... spl_id 6a062096-6569-45c1-9184-11e9973cc3c8, 241c4b7e-f719-4828-8639-ea613b8a6583, df98 ... spl_set_id 993bedd3-2f7c-40ff-87dc-8a55c6c7a3c7, 241c4b7e-f719-4828-8639-ea613b8a6583, 2d83 ... Package NDC 69539-011-90, 69539-011-99, 69539-011-11, 69539-011-06, 69539-012-90, 69539-012- ... UNII55JG375S6M

5)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKactiondrug5drugrecurreadministration3

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

6)

drugcharacterization2medicinalproductTERAZOSINdrugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTERAZOSIN\TERAZOSIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075317Brand NameTERAZOSINGeneric NameTERAZOSIN HYDROCHLORIDEManufacturersJubilant Cadista Pharmaceuticals Inc.product_ndc59746-383, 59746-384, 59746-385, 59746-386Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERAZOSIN HYDROCHLORIDERXCUI260376, 313215, 313217, 313219spl_idf5ff6fc2-dd2d-4f3b-8e05-ec0e952f0f21spl_set_id43e92495-2cf2-46dd-a80c-f0c3c88c7b73Package NDC 59746-383-90, 59746-383-06, 59746-383-09, 59746-383-10, 59746-384-90, 59746-384- ... UNIID32S14F082

7)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MG, UNKactiondrug5drugrecurreadministration3

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

8)

drugcharacterization2medicinalproductPRILOSECdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharmaproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_id1bd73b0f-b2c2-4409-94ce-1955c6ab119bspl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

9)

drugcharacterization2medicinalproductSIMVASTATIN.drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

10)

drugcharacterization2medicinalproductAPAPdrugindicationBACK PAINactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart343Brand NameAPAPGeneric NameACETAMINOPHENManufacturersAdvance Pharmaceutical Inc., Richmond Pharmaceuticals, Inc.product_ndc17714-013, 54738-040, 54738-540, 17714-014Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHENRXCUI198440spl_id 60f41580-e099-faad-e053-2a91aa0a9076, 5cc3aaa6-e19e-a116-e053-2991aa0a1422, 5cc3 ... spl_set_id aba26f0a-94e4-4919-a3b0-033e3a9598ef, a30388fa-0d85-4eb3-babd-228170ebe96d, ad08 ... Package NDC 17714-013-01, 17714-013-10, 54738-040-01, 54738-040-03, 54738-540-01, 54738-540- ... UNII362O9ITL9D

11)

drugcharacterization2medicinalproductBACLOFEN.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKactiondrug5drugrecurreadministration3

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

12)

drugcharacterization2medicinalproductDALFAMPRIDINEdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application Number NDA022250, ANDA208292, ANDA206765, ANDA206646, ANDA210158, ANDA206863, ANDA20681 ... Brand NameAMPYRA, DALFAMPRIDINEGeneric NameDALFAMPRIDINEManufacturers Acorda Therapeutics, Inc., Sun Pharmaceutical Industries, Inc., Mylan Pharmaceut ... product_ndc 10144-427, 62756-429, 0378-0509, 67877-444, 0054-0479, 42571-275, 16729-292, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_id 99d8ffc6-164d-b055-e053-2995a90ad0c9, f9430b51-f634-4192-a946-06008f90795d, 8501 ... spl_set_id 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783, d61e15fa-0334-49a0-ab41-c9a36b726b57, 8501 ... Package NDC 10144-427-60, 62756-429-86, 0378-0509-91, 67877-444-60, 67877-444-90, 67877-444- ... NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

13)

drugcharacterization2medicinalproductASAdrugstructuredosagenumb81drugstructuredosageunit003drugdosagetext81 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

14)

drugcharacterization2medicinalproductALPRAZOLAM.drugstructuredosagenumb.25drugstructuredosageunit003drugdosagetext0.25 MG, UNKactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

summary

narrativeincludeclinicalCASE EVENT DATE: 20140510

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHEH2014US009702

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use