Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10090064serious1Date Last Updated21/04/2014receiptdateformat102companynumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-17352BPoccurcountryUSseriousnessother1duplicate1Date Received21/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionCerebrovascular accidentOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionCerebrovascular accidentOutcomeRecovered/resolved with sequelae (consequent health issues)

3)

reactionmeddraversionpt17.0ReactionCarotid artery occlusionOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionBalance disorderOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionAmnesiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAGGRENOXdrugauthorizationnumb020884drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSTRENGTH: 25 MG / 200 MG; DAILY DOSE: 50 MG / 400 MGdrugdosageformCAPSULEdrugadministrationroute048drugindicationCEREBROVASCULAR ACCIDENT PROPHYLAXISdrugstartdateformat602drugstartdate//1999actiondrug4

openFDA Info on Medication

Application NumberNDA020884Brand NameAGGRENOXGeneric NameASPIRIN AND DIPYRIDAMOLEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsASPIRIN, DIPYRIDAMOLERXCUI259081, 1362082spl_iddd752f90-5b56-4d68-8896-4e363d06aa6cspl_set_id938ab0b5-8377-404a-8f61-5c630bda5932Package NDC0597-0001-60, 0597-0001-11NUIN0000000160, 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, 64ALC7F90C

2)

drugcharacterization2medicinalproductSERTRALINEdrugadministrationroute048

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

3)

drugcharacterization2medicinalproductMETOPROLOLdrugadministrationroute048

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

4)

drugcharacterization2medicinalproductFAMOTIDINEdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA075400, ANDA077351, ANDA206531, ANDA090837, ANDA078916, ANDA090283, ANDA0755 ... Brand Name ACID CONTROLLER, HARRIS TEETER ACID REDUCER, HEARTBURN PREVENTION, FAMOTIDINE, R ... Generic NameFAMOTIDINEManufacturers H E B, Harris Teeter, LLC, Kroger Company, Wal-Mart Stores, Inc., Aurohealth LLC ... product_ndc 37808-301, 69256-141, 30142-194, 49035-589, 58602-705, 37808-042, 0536-1298, 646 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFAMOTIDINERXCUI 199047, 310273, 284245, 204441, 1743833, 310274, 104094, 206873, 199739, 104095, ... spl_id 1f77609d-de4d-4f77-9472-a072f8d73890, f33706dc-725a-4d6d-af1e-ede3740b1674, 5445 ... spl_set_id 813d742f-8f3d-4f18-a6c5-03eea946f976, af2c0c51-ac28-4bf4-8e60-ba6e12bfc302, c978 ... Package NDC 37808-301-65, 37808-301-72, 69256-141-65, 30142-194-71, 30142-194-02, 30142-194- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

5)

drugcharacterization2medicinalproductSIMVASTATINdrugadministrationroute048

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

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbUS-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-17352BP

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use