Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10169250serious1Date Last Updated10/06/2014receiptdateformat102companynumbGB-ELI_LILLY_AND_COMPANY-GB201405000546occurcountryGBseriousnessother1duplicate1Date Received13/05/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Onset Age60Unit of Onset AgeyearsWeight57SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionMyocardial infarctionOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionSuicidal ideationOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDrug withdrawal syndromeOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPROZACdrugauthorizationnumb018936drugdosagetextUNK, UNKNOWNdrugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat602drugstartdate//2012drugenddateformat102drugenddate22/01/2014actiondrug1drugrecurreadministration3

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_idef027dfe-1ccd-4c52-ad10-c76d6834d10cspl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-07, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

2)

drugcharacterization1medicinalproductSERTRALINEdrugdosagetextUNK, UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1drugrecurreadministration3

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, 6dce ... 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

Report Duplicate

duplicatesourceELI LILLY AND COduplicatenumbGB-ELI_LILLY_AND_COMPANY-GB201405000546

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use