Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10095567serious1Date Last Updated22/04/2014receiptdateformat102companynumbGB-WATSON-2014-08415occurcountryGBseriousnessother1duplicate1Date Received22/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age48Unit of Onset AgeyearsWeight68SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionGastrooesophageal reflux diseaseOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionOesophagitisOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductBUSPIRONE (UNKNOWN)drugbatchnumbUNCONFIRMEDdrugauthorizationnumb074253drugdosagetextUNKdrugdosageformUnkdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/01/2014actiondrug5

2)

drugcharacterization2medicinalproductBUPRENORPHINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate24/12/2013actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA209819, ANDA201760, NDA021306, ANDA207276, ANDA204937, ANDA090819, ANDA211586Brand NameSUBLOCADE, BUPRENORPHINE, BUTRANSGeneric NameBUPRENORPHINEManufacturers Indivior Inc., Sun Pharmaceutical Industries, Inc., Purdue Pharma LP, Rhodes Pha ... product_ndc 12496-0100, 12496-0300, 62756-459, 62756-460, 59011-750, 59011-751, 59011-758, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, SUBLINGUAL, TRANSDERMALActive IngredientsBUPRENORPHINE, BUPRENORPHINE HYDROCHLORIDERXCUI 1996184, 1996189, 1996192, 1996193, 351264, 351265, 904870, 904874, 904876, 9048 ... spl_id af8efe6f-49c7-4b54-9bfd-7936c47a96a7, aaa3ba84-76a6-41a8-9ace-03aade6416ec, 0007 ... spl_set_id 6189fb21-9432-45f8-8481-0bfaf3ccde95, 9fd1f18f-0b0f-4059-b603-19ecbf0ed63a, 794a ... Package NDC 12496-0100-5, 12496-0100-2, 12496-0100-1, 12496-0300-5, 12496-0300-2, 12496-0300 ... NUIN0000175689, N0000175685Established Pharmacologic ClassPartial Opioid Agonist [EPC]Mechanism of ActionPartial Opioid Agonists [MoA]UNII40D3SCR4GZ, 56W8MW3EN1

3)

drugcharacterization2medicinalproductDOMPERIDONEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/01/2014drugenddateformat102drugenddate18/02/2014actiondrug5drugrecurreadministration3

4)

drugcharacterization2medicinalproductDOMPERIDONEdrugdosagetextUNKdrugadministrationroute065drugstartdateformat102drugstartdate24/12/2013actiondrug5drugrecurreadministration3

5)

drugcharacterization2medicinalproductDULCOLAX /00064401/drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate18/12/2013drugenddateformat102drugenddate15/01/2014actiondrug5drugrecurreadministration3

6)

drugcharacterization2medicinalproductLANSOPRAZOLEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate08/11/2013actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA202319, ANDA203306, ANDA203187, ANDA202366, NDA208025, ANDA091269, ANDA20217 ... Brand Name EQUALINE LANSOPRAZOLE, LANSOPRAZOLE, EQUATE LANSOPRAZOLE DELAYED RELEASE, EQUATE ... Generic NameLANSOPRAZOLE, LANSOPRAZOLE DELAYED RELEASEManufacturers Supervalu Inc, HEB, Chain Drug Consortium, LLC, Cadila Healthcare Limited, Perri ... product_ndc 41163-117, 37808-448, 68016-758, 65841-769, 65841-770, 45802-245, 49035-411, 490 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI596843, 311277, 351261, 206205, 206206, 351260, 596918, 866152spl_id a9daca89-e2f8-40bf-9beb-4267aaac7d3e, c7379031-b622-41be-8afd-ac1f44ff4e33, a60e ... spl_set_id ea8efda5-9d08-446b-9424-68a98122589a, 3496e421-3d42-4b1e-9ea2-0ffc03bb81ed, 5452 ... Package NDC 41163-117-01, 41163-117-02, 41163-117-03, 37808-448-14, 37808-448-42, 68016-758- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

7)

drugcharacterization2medicinalproductMEBEVERINE HYDROCHLORIDEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate24/12/2013actiondrug5drugrecurreadministration3

8)

drugcharacterization2medicinalproductSALBUTAMOLdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate24/12/2013actiondrug5drugrecurreadministration3

9)

drugcharacterization2medicinalproductSALMETEROLdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/03/2014actiondrug5drugrecurreadministration3

10)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate24/12/2013actiondrug5drugrecurreadministration3

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

Report Duplicate

duplicatesourceWATSONduplicatenumbGB-WATSON-2014-08415

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use