Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10086998serious1Date Last Updated22/02/2016receiptdateformat102authoritynumbGB-MHRA-EYC 00109824companynumbGB-BRISTOL-MYERS SQUIBB COMPANY-20605929occurcountryGBseriousnessother1duplicate1Date Received18/04/2014transmissiondate25/05/2016primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age51Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionErythemaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.0ReactionPruritusOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.0ReactionPainOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.0ReactionSkin depigmentationOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt19.0ReactionProduct use issueOutcomeUnknown

7)

reactionmeddraversionpt19.0ReactionSkin atrophyOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

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

2)

drugcharacterization1medicinalproductKENALOGdrugbatchnumb3D75814drugauthorizationnumb012041drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugdosageformSUSPENSION FOR INJECTIONdrugadministrationroute030drugindicationSKIN DEPIGMENTATIONdrugstartdateformat102drugstartdate14/11/2013actiondrug1

activesubstance

activesubstancenameTRIAMCINOLONE ACETONIDE

openFDA Info on Medication

Application NumberNDA012104, NDA014901Brand NameKENALOG, PRO-C-DURE 6 KIT, PRO-C-DURE 5 KITGeneric NameTRIAMCINOLONE ACETONIDE, KENALOGManufacturersSun Pharmaceutical Industries, Inc., Oaklock, LLCproduct_ndc10631-093, 69263-821, 69263-820Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICAL, INTRA-ARTICULAR, INTRAMUSCULARActive IngredientsTRIAMCINOLONE ACETONIDERXCUI1085736, 1085738, 1085754, 1085756spl_id eeb0548e-810f-4609-b3f0-fae397161fc8, a0974cb2-15b4-3549-e053-2a95a90a52b3, a097 ... spl_set_id cdf6c80c-ddbd-498f-8897-3c0feebafe31, 1129a728-b619-4cf8-8fc8-13bf1ef8a8fb, 68fc ... Package NDC 10631-093-62, 10631-093-07, 10631-093-35, 10631-093-96, 69263-821-01, 0003-0293- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIF446C597KA

3)

drugcharacterization1medicinalproductHYDROCORTISONE.drugbatchnumb014414drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, UNKdrugadministrationroute030drugindicationTENOSYNOVITIS STENOSANSdrugstartdateformat102drugstartdate17/10/2013actiondrug1

activesubstance

activesubstancenameHYDROCORTISONE

openFDA Info on Medication

Application Number part348, ANDA088799, ANDA040351, ANDA089682, ANDA080706, NDA213876, ANDA040646, ... Brand Name HARRIS TEETER ANTI-ITCH WITH ALOE, DG HEALTH HYDROCORTISONE, PROCTOSOL-HC, GOOD ... Generic Name HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, ANTI-ITCH, HYDROCORTI ... Manufacturers Harris Teeter, Dolgencorp, LLC, Sun Pharmaceutical Industries, Inc., Amerisource ... product_ndc 72036-407, 55910-646, 10631-407, 24385-276, 67091-280, 69396-069, 61010-4402, 70 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, RECTALActive IngredientsHYDROCORTISONE, HYDROCORTISONE ACETATERXCUI 106258, 103403, 310891, 1540356, 203105, 197785, 1790684, 206352, 1043063, 19870 ... spl_id 2b90d9a3-ebb1-4aee-8a9c-6601618b7738, 27dc9e09-fc4f-4b66-a303-177725f3a513, 297a ... spl_set_id 1755c97e-87a3-43c7-ab61-3e971a7b3135, 27dc9e09-fc4f-4b66-a303-177725f3a513, 5652 ... Package NDC 72036-407-28, 55910-646-25, 10631-407-01, 24385-276-03, 67091-280-28, 69396-069- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ, 3X7931PO74

Report Duplicate

duplicatesourceBRISTOL MYERS SQUIBBduplicatenumbGB-BRISTOL-MYERS SQUIBB COMPANY-20605929

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use