Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10062258serious1Date Last Updated07/04/2014receiptdateformat102companynumbGB-VERTEX PHARMACEUTICALS INC-2014-001294occurcountryGBseriousnessother1duplicate1Date Received07/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Onset Age37Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionSensory disturbanceOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionSensory disturbanceOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionIrritabilityOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionElevated moodOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionRashOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductINCIVOdrugbatchnumbDCL0W00drugauthorizationnumb201917drugstructuredosagenumb1135drugstructuredosageunit003drugdosagetextON DRUG X 6WEEKSdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/01/2014drugenddateformat102drugenddate11/03/2014actiondrug1drugrecurreadministration3

2)

drugcharacterization1medicinalproductRIBAVIRINdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugcumulativedosagenumb18000drugcumulativedosageunit003drugdosagetext600 MG, BIDdrugadministrationroute048drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate13/01/2014drugenddateformat102drugenddate11/03/2014actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA018859, ANDA077094, ANDA207366, ANDA077224, ANDA079111, ANDA079117, NDA021546Brand NameVIRAZOLE, RIBAVIRIN, REBETOLGeneric NameRIBAVIRINManufacturers Bausch Health US, LLC, Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) In ... product_ndc 0187-0007, 65841-046, 65841-603, 65841-632, 65841-129, 68382-046, 68382-127, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), ORALActive IngredientsRIBAVIRINRXCUI207406, 312818, 248109, 597718, 597722, 790286, 312817, 248112, 352007, 544400spl_id 73a3e060-c827-40d8-925c-2d02b9313070, 1596fe48-b374-4c0c-b2ae-1ceb802ca2ba, b46a ... spl_set_id adf16e64-345f-469a-b987-3fbdd17e0ac2, 666e8b22-f519-460b-a774-88a621d56139, 0899 ... Package NDC 0187-0007-14, 0187-0007-01, 65841-046-03, 65841-046-28, 65841-046-10, 65841-046- ... NUIN0000175459, N0000175466Established Pharmacologic ClassNucleoside Analog Antiviral [EPC]UNII49717AWG6K

3)

drugcharacterization1medicinalproductPEGASYSdrugstructuredosagenumb180drugstructuredosageunit004drugdosagetext180 ?G, UNKdrugadministrationroute058drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate13/01/2014drugenddateformat102drugenddate11/03/2014actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application NumberBLA103964Brand NamePEGASYSGeneric NamePEGINTERFERON ALFA-2AManufacturersGenentech, Inc.product_ndc0004-0350, 0004-0357Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGINTERFERON ALFA-2ARXCUI351270, 352297, 731326, 731328spl_id5e9bb3e4-48f9-4b34-9c4f-7a6f27ffd98cspl_set_idde61685e-2b8c-4e22-84bb-869e13600440Package NDC0004-0350-09, 0004-0357-30NUIN0000175521, M0025711Established Pharmacologic ClassInterferon alpha [EPC]Chemical StructureInterferon-alpha [CS]UNIIQ46947FE7K

4)

drugcharacterization2medicinalproductSALBUTAMOLdrugrecurreadministration3

5)

drugcharacterization2medicinalproductMETHADONEdrugstructuredosagenumb25drugstructuredosageunit003drugindicationWITHDRAWAL SYNDROMEdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA204166Brand NameMETHADONE HYDROCHLORIDEGeneric NameMETHADONEManufacturersVistaPharm, Inc.product_ndc66689-836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHADONE HYDROCHLORIDERXCUI864706spl_id00594a6e-2875-4640-95cc-e8bcff7541bcspl_set_id4a44bde6-c348-4316-b0e0-c24b407cb823Package NDC66689-836-99UNII229809935B

6)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugindicationDEPRESSIONdrugrecurreadministration3

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

duplicatesourceVERTEXduplicatenumbGB-VERTEX PHARMACEUTICALS INC-2014-001294

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use