Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10061359serious1Date Last Updated16/05/2014receiptdateformat102companynumbBE-BAYER-2014-051191occurcountryBEduplicate1Date Received07/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryBE

Primary Source

reportercountryBEqualification1

Patient

Onset Age56Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionThrombotic microangiopathy

2)

reactionmeddraversionpt17.0ReactionHypertension

3)

reactionmeddraversionpt17.0ReactionMyocardial infarction

Drug

1)

drugcharacterization1medicinalproductBETAFERONdrugauthorizationnumb103471drugdosagetextUNKdrugdosageformPOWDER AND SOLVENT FOR SOLUTION FOR INJECTIONdrugindicationMULTIPLE SCLEROSISdrugstartdateformat602drugstartdate//2004drugenddateformat610drugenddate/03/2014

2)

drugcharacterization2medicinalproductBACLOFENdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

3)

drugcharacterization2medicinalproductLYSANXIAdrugdosagetextUNK

4)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugstartdateformat610drugstartdate/03/2014

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

5)

drugcharacterization2medicinalproductZOROXINdrugindicationURINARY TRACT INFECTION

Report Duplicate

duplicatesourceBAYERduplicatenumbBE-BAYER-2014-051191

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use