Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11972877primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/05/2016reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received28/01/2016receiptdateformat102Date Last Updated25/02/2016fulfillexpeditecriteria2companynumbUS-CELGENEUS-USA-2016015305duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-USA-2016015305

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age83Unit of Onset AgeyearsWeight101.24SexMale

Reaction

1)

reactionmeddraversionpt19.0ReactionPulmonary oedemaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.0ReactionPneumoniaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.0ReactionCardiac failureOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.0ReactionRenal failureOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductOSTEO BI-FLEXdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCHONDROITIN SULFATE A\GLUCOSAMINE

2)

drugcharacterization2medicinalproductTYLENOLdrugdosagetext1 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id da433eb1-9a1d-276e-e053-2a95a90a7794, dfd72ee1-40ac-6983-e053-2995a90a4d94, da40 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... NUIN0000193956, N0000008867, N0000009560Established Pharmacologic ClassExpectorant [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

3)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

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

4)

drugcharacterization2medicinalproductOCUVITEdrugdosagetext325 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameVITAMINS

5)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbC0086Bdrugauthorizationnumb204026drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULESdrugadministrationroute048drugstartdateformat610drugstartdate/01/2014actiondrug4drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id0e50dfc9-35ac-4b11-89f1-5c3653717c3dspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

6)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbC0086Bdrugauthorizationnumb204026drugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULESdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat610drugstartdate/10/2013actiondrug4drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id0e50dfc9-35ac-4b11-89f1-5c3653717c3dspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

7)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstructuredosagenumb4drugstructuredosageunit003drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

8)

drugcharacterization2medicinalproductOMEPRAZOLE.drugdosagetext4 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

9)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumbC0086Bdrugauthorizationnumb204026drugstructuredosagenumb2drugstructuredosageunit003drugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate18/03/2015actiondrug4drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id0e50dfc9-35ac-4b11-89f1-5c3653717c3dspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

10)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb325drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 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

11)

drugcharacterization2medicinalproductMEGACEdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMEGESTROL ACETATE

summary

narrativeincludeclinicalCASE EVENT DATE: 20160122