Adverse Event Report

Report

reporttype3Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10069740serious1Date Last Updated01/08/2014receiptdateformat102seriousnessdeath1companynumbGB-LUPIN PHARMACEUTICALS INC.-E2B_00001915occurcountryGBduplicate1Date Received10/04/2014transmissiondate26/03/2015primarysourcecountryGB

Primary Source

reportercountryGB

Patient

Onset Age37Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDrug interactionOutcomeFatal

2)

reactionmeddraversionpt17.1ReactionOverdoseOutcomeFatal

Drug

1)

drugcharacterization2medicinalproductPREGABALIN.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application Number ANDA209357, ANDA206912, NDA209501, ANDA203459, ANDA212865, ANDA091157, ANDA20762 ... Brand NamePREGABALIN, LYRICA CR, LYRICAGeneric NamePREGABALINManufacturers MSN LABORATORIES PRIVATE LIMITED, Camber Pharmaceuticals, Inc., Parke-Davis Div ... product_ndc 69539-011, 69539-012, 69539-013, 69539-014, 69539-015, 69539-016, 69539-017, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 1988974, 1988977 ... spl_id 6a062096-6569-45c1-9184-11e9973cc3c8, 241c4b7e-f719-4828-8639-ea613b8a6583, df98 ... spl_set_id 993bedd3-2f7c-40ff-87dc-8a55c6c7a3c7, 241c4b7e-f719-4828-8639-ea613b8a6583, 2d83 ... Package NDC 69539-011-90, 69539-011-99, 69539-011-11, 69539-011-06, 69539-012-90, 69539-012- ... UNII55JG375S6M

2)

drugcharacterization2medicinalproductOMEPRAZOLE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

3)

drugcharacterization1medicinalproductOXYCODONE HYDROCHLORIDE.drugbatchnumbUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA205853, ANDA207418, NDA022272, ANDA203638, ANDA208795, ANDA204021, ANDA20989 ... Brand NameOXYCODONE HYDROCHLORIDE, OXYCONTIN, ROXICODONE, OXAYDOGeneric NameOXYCODONE HYDROCHLORIDE, OXYCODONEManufacturers Rhodes Pharmaceuticals L.P., Camber Pharmaceuticals Inc, Purdue Pharma LP, Amnea ... product_ndc 42858-010, 31722-917, 31722-918, 59011-410, 59011-480, 59011-415, 59011-420, 590 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049615, 1049611, 1049618, 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, ... spl_id bab5f88d-95e5-6e41-c800-4e3b85583d10, 69cd1131-3a4e-4e63-9734-1b1e3f4ee5c9, 21ec ... spl_set_id bab5f88d-95e5-6e41-c800-4e3b85583d10, 01db4606-d49c-4b10-a78a-1cf41880a9fb, bfdf ... Package NDC 42858-010-15, 31722-917-01, 31722-917-05, 31722-918-01, 31722-918-05, 59011-480- ... UNIIC1ENJ2TE6C

4)

drugcharacterization3medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb077670drugadministrationroute048drugindicationANXIETYdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20131008

Report Duplicate

duplicatesourceLUPINduplicatenumbGB-LUPIN PHARMACEUTICALS INC.-E2B_00001915

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use