Adverse Event Report

Report

reporttype1receiptdateformat102companynumbSYM-2014-18383Version of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10028167Date Received19/03/2014seriousnesshospitalization1transmissiondate02/10/2014serious1Date Last Updated19/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAnxiety

2)

reactionmeddraversionpt17.0ReactionCardiac disorder

Drug

1)

drugcharacterization1medicinalproductATIVANdrugauthorizationnumb017794drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

2)

drugcharacterization1medicinalproductZOLOFTdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductCOUMADIN (WARFARIN SODIUM)

4)

drugcharacterization2medicinalproductSOTALOL

openFDA Info on Medication

Application NumberANDA207428Brand NameSOTALOLGeneric NameSOTALOL HYDROCHLORIDEManufacturersBayshore Pharmaceuticals LLCproduct_ndc76385-114, 76385-115, 76385-116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOTALOL HYDROCHLORIDERXCUI1923422, 1923424, 1923426spl_id6d091d32-9a0e-45ad-a9a1-35dc92dbe8a0spl_set_id56879738-8662-4f5c-8386-761ab2b5e46fPackage NDC 76385-114-01, 76385-114-50, 76385-115-01, 76385-115-50, 76385-116-01, 76385-116- ... UNIIHEC37C70XX

5)

drugcharacterization2medicinalproductREMERON (MIRTAZAPINE)

Report Duplicate

duplicatesourceVALEANTduplicatenumbSYM-2014-18383