Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10165088primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received10/05/2014receiptdateformat102Date Last Updated10/05/2014fulfillexpeditecriteria2companynumbUS-BRISTOL-MYERS SQUIBB COMPANY-19721349duplicate1

Report Duplicate

duplicatesourceBRISTOL MYERS SQUIBBduplicatenumbUS-BRISTOL-MYERS SQUIBB COMPANY-19721349

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age57Unit of Onset AgeyearsWeight97.05SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug interactionOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionOff label useOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionImpaired gastric emptyingOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductBYDUREONdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugadministrationroute058drugindicationPOLYCYSTIC OVARIESdrugstartdateformat602drugstartdate//2013actiondrug4

openFDA Info on Medication

Application NumberNDA022200Brand NameBYDUREONGeneric NameEXENATIDEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0310-6530, 0310-6520Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsEXENATIDERXCUI1242963, 1242968, 1544916, 1544918spl_ide3b3cf10-abf0-4415-969c-7117fa7ec755spl_set_id71fe88be-b4e6-4c2d-9cc3-8b1864467776Package NDC0310-6530-04, 0310-6530-01, 0310-6530-85, 0310-6520-04NUIN0000178480, M0160181, N0000020058Established Pharmacologic ClassGLP-1 Receptor Agonist [EPC]Chemical StructureGlucagon-Like Peptide 1 [CS]Mechanism of ActionGlucagon-like Peptide-1 (GLP-1) Agonists [MoA]UNII9P1872D4OL

2)

drugcharacterization3medicinalproductLUNESTAdrugadministrationroute048drugindicationSLEEP DISORDERdrugstartdateformat102drugstartdate27/10/2013

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

3)

drugcharacterization2medicinalproductGLUMETZAdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1DF:1000 UNIT NOSdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021748Brand NameGLUMETZAGeneric NameMETFORMIN HYDROCHLORIDEManufacturersSantarus, Inc.product_ndc68012-002, 68012-004, 68012-003Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI861015, 861018, 1807888, 1807915spl_id039bd4a8-cf35-4946-8079-ca0aef70b829spl_set_idfb832474-88d9-4e29-95cd-fbc446944cc4Package NDC68012-004-50, 68012-002-13, 68012-002-92, 68012-003-16, 68012-003-97UNII786Z46389E