Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-12914BPoccurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10050242Date Received01/04/2014transmissiondate12/12/2014serious2Date Last Updated01/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age67Unit of Onset AgeyearsWeight64SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionCoughOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionHeart rate decreasedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionBlood pressure increasedOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionHaemoptysisOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductPRADAXAdrugbatchnumb304084drugauthorizationnumb022512drugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MGdrugdosageformCAPSULEdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat610drugstartdate/02/2014actiondrug4

openFDA Info on Medication

Application NumberNDA022512Brand NamePRADAXAGeneric NameDABIGATRAN ETEXILATE MESYLATEManufacturersBoehringer Ingelheim Pharmaceuticals Inc.product_ndc0597-0108, 0597-0355, 0597-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDABIGATRAN ETEXILATE MESYLATERXCUI1037045, 1037049, 1037179, 1037181, 1723476, 1723478spl_idfdeb89cd-11fc-4393-8fe7-a497e11a9cc8spl_set_idba74e3cd-b06f-4145-b284-5fd6b84ff3c9Package NDC 0597-0108-54, 0597-0108-60, 0597-0355-09, 0597-0355-56, 0597-0355-53, 0597-0360- ... UNIISC7NUW5IIT

2)

drugcharacterization2medicinalproductENALAPRILdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MGdrugdosageformTABLETdrugadministrationroute048drugindicationATRIAL FIBRILLATION

3)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext81 MGdrugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

4)

drugcharacterization2medicinalproductFENOFIBRATEdrugstructuredosagenumb160drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext160 MGdrugdosageformTABLETdrugadministrationroute048drugindicationBLOOD TRIGLYCERIDES INCREASED

openFDA Info on Medication

Application Number ANDA211080, ANDA202676, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA2051 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, FENOGLIDE, LIPOFENGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals NY ... product_ndc 43547-430, 43547-431, 0378-8628, 0378-8629, 0378-8630, 69238-1262, 69238-1263, 1 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 349287, 351133, 200311, 310288, 310289, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, 1e5c1d27-15e1-465e-b19c-738bf855e6d4, 0be7 ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 66d2c555-2880-4ac6-80f8-69a00f1fbc4c, 7e79 ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 0378-8628-77, 0378-8629- ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

5)

drugcharacterization2medicinalproductGLIMEPIRIDEdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext8 MGdrugdosageformTABLETdrugadministrationroute048drugindicationDIABETES MELLITUS

openFDA Info on Medication

Application Number ANDA077911, ANDA077091, ANDA091220, ANDA078181, NDA020496, ANDA077370, ANDA20275 ... Brand NameGLIMEPIRIDE, AMARYLGeneric NameGLIMEPIRIDEManufacturers Carlsbad Technology, Inc., Dr. Reddy's Laboratories Limited, Micro Labs Limited, ... product_ndc 61442-115, 61442-116, 61442-117, 55111-320, 55111-321, 55111-322, 42571-100, 425 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI199245, 199246, 199247, 153842, 1361493, 1361495, 153591, 153843, 153845spl_id 94f7e51b-3f92-8633-e053-2995a90a8cf1, e3d50334-9896-b2f9-a481-8383eb84b16a, ab8d ... spl_set_id 72d88c6d-2f0a-4bf8-aa7f-1e1811794187, 07ad4366-4b21-f633-49f3-c2b35f88168d, 60e9 ... Package NDC 61442-115-01, 61442-115-05, 61442-115-10, 61442-116-01, 61442-116-05, 61442-116- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

6)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MGdrugdosageformTABLETdrugadministrationroute048drugindicationDIABETES MELLITUS

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, a353 ... 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

7)

drugcharacterization2medicinalproductMETOPROLOLdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MGdrugdosageformTABLETdrugadministrationroute048drugindicationATRIAL FIBRILLATION

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

8)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MGdrugdosageformTABLETdrugadministrationroute048drugindicationDEPRESSION

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

9)

drugcharacterization2medicinalproductFLONASEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextFORMULATION: NASAL SPRAYdrugadministrationroute045drugindicationASTHMA

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

10)

drugcharacterization2medicinalproductJANUVIAdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MGdrugdosageformTABLETdrugadministrationroute048drugindicationDIABETES MELLITUS

openFDA Info on Medication

Application NumberNDA021995Brand NameJANUVIAGeneric NameSITAGLIPTINManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0112, 0006-0221, 0006-0277Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSITAGLIPTIN PHOSPHATERXCUI665033, 665036, 665038, 665040, 665042, 665044spl_id26191c72-2372-41ac-8ddf-e28322dcb9ccspl_set_idf85a48d0-0407-4c50-b0fa-7673a160bf01Package NDC 0006-0221-01, 0006-0221-28, 0006-0221-31, 0006-0221-54, 0006-0112-01, 0006-0112- ... UNIITS63EW8X6F

11)

drugcharacterization2medicinalproductAMIODARONEdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MGdrugdosageformTABLETdrugadministrationroute048drugindicationATRIAL FLUTTER

12)

drugcharacterization2medicinalproductSIMVASTATINdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MGdrugdosageformTABLETdrugadministrationroute048drugindicationBLOOD CHOLESTEROL INCREASED

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

13)

drugcharacterization2medicinalproductADVAIRdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext FORMULATION: INHALATION AEROSOL, DOSE PER APPLICATION: 250MCG/50MCG, DAILY DOSE: ... drugadministrationroute055drugindicationASTHMA

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-12914BP