Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-SA-2014SA038898occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10202849Date Received22/05/2014transmissiondate12/12/2014serious2Date Last Updated22/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age46Unit of Onset AgeyearsWeight54.8SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionCystitisOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionBlood glucose increasedOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductLANTUS SOLOSTARdrugbatchnumb3F409Adrugauthorizationnumb021081drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextSTARTED 4 YEARS AGO DOSE:11 UNIT(S)drugadministrationroute058drugindicationTYPE 1 DIABETES MELLITUSdrugstartdateformat610drugstartdate/05/2008actiondrug4

openFDA Info on Medication

Application NumberBLA021081Brand NameLANTUS SOLOSTARGeneric NameINSULIN GLARGINEManufacturerssanofi-aventis U.S. LLCproduct_ndc0088-2219, 0088-2220, 0088-5020, 0088-5021Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsINSULIN GLARGINERXCUI285018, 311041, 847230, 847232spl_id0a57f187-f101-4268-851f-7f20c7f708f9, 4e455ace-94f4-4fa3-85eb-0152e5a06239spl_set_idd5e07a0c-7e14-4756-9152-9fea485d654a, 6328c99d-d75f-43ef-b19e-7e71f91e57f6Package NDC 0088-2220-33, 0088-2220-34, 0088-2219-00, 0088-2219-01, 0088-2219-05, 0088-5021- ... NUIN0000004931, N0000175453Chemical StructureInsulin [Chemical/Ingredient]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ

2)

drugcharacterization2medicinalproductLEVOTHYROXINEdrugstructuredosagenumb75drugstructuredosageunit004drugindicationHYPOTHYROIDISMdrugstartdateformat602drugstartdate//1980

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

3)

drugcharacterization2medicinalproductPRAVASTATINdrugstructuredosagenumb40drugstructuredosageunit003drugindicationPROPHYLAXISdrugstartdateformat602drugstartdate//2009

4)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb125drugstructuredosageunit003drugindicationANXIETYdrugstartdateformat602drugstartdate//2008

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

5)

drugcharacterization2medicinalproductLEVETIRACETAMdrugstructuredosagenumb500drugstructuredosageunit003drugindicationCONVULSIONdrugstartdateformat602drugstartdate//2013

openFDA Info on Medication

Application Number ANDA202869, ANDA090515, ANDA078904, NDA021872, ANDA091399, ANDA078858, ANDA07810 ... Brand Name LEVETIRACETAM, KEPPRA, LEVETIRACETAM LEVETIRACETAM, ROWEEPRA, LEVETIRACETAM EXTE ... Generic NameLEVETIRACETAM, LEVETIRACETAM INJECTIONManufacturers Hospira, Inc., NorthStar RxLLC, Dr. Reddy's Laboratories Limited, UCB, Inc., Lup ... product_ndc 0409-1886, 16714-035, 55111-248, 50474-002, 68180-117, 68180-118, 13668-014, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORAL, INTRAVASCULARActive IngredientsLEVETIRACETAMRXCUI 647121, 311289, 387003, 647123, 807832, 846378, 311288, 311290, 403884, 1875868, ... spl_id 3570b20d-b176-4f93-8e99-e7d71de7786b, 3884cb76-822b-400d-9b24-49c286c9b6f7, 1b3a ... spl_set_id 56de8d14-7860-4b3a-944c-a5c8f34a0935, 3884cb76-822b-400d-9b24-49c286c9b6f7, 1f3c ... Package NDC 0409-1886-15, 0409-1886-05, 16714-035-01, 16714-035-02, 55111-248-30, 55111-248- ... NUIN0000008486Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII44YRR34555

6)

drugcharacterization2medicinalproductMULTIVITAMINSdrugstructuredosagenumb1drugstructuredosageunit032drugdosageformTABLETdrugindicationNUTRITIONAL SUPPLEMENTATION

7)

drugcharacterization2medicinalproductSOLOSTARdrugstartdateformat610drugstartdate/05/2008

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-2014SA038898