Adverse Event Report

Report

reporttype1Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10136372serious1Date Last Updated07/01/2020seriousnesslifethreatening1receiptdateformat102authoritynumbGB-MHRA-ADR 22496422companynumbGB-ACCORD-023311occurcountryGBseriousnessother1duplicate1Date Received29/04/2014transmissiondate09/04/2020primarysourcecountryGB

Primary Source

reportercountryGBqualification5

Patient

Onset Age23Unit of Onset AgeyearsWeight88.9SexMale

Reaction

1)

reactionmeddraversionpt22.1ReactionSleep apnoea syndromeOutcomeRecovering/resolving

2)

reactionmeddraversionpt22.1ReactionAmnesiaOutcomeRecovering/resolving

3)

reactionmeddraversionpt22.1ReactionParaesthesiaOutcomeRecovering/resolving

4)

reactionmeddraversionpt22.1ReactionAbdominal painOutcomeRecovering/resolving

5)

reactionmeddraversionpt22.1ReactionMedication errorOutcomeUnknown

6)

reactionmeddraversionpt22.1ReactionChest discomfortOutcomeRecovering/resolving

7)

reactionmeddraversionpt22.1ReactionFluid retentionOutcomeRecovering/resolving

8)

reactionmeddraversionpt22.1ReactionSpeech disorderOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt22.1ReactionAstheniaOutcomeRecovering/resolving

10)

reactionmeddraversionpt22.1ReactionDyspnoeaOutcomeRecovering/resolving

11)

reactionmeddraversionpt22.1ReactionDepressed level of consciousnessOutcomeRecovering/resolving

12)

reactionmeddraversionpt22.1ReactionMemory impairmentOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt22.1ReactionPhotosensitivity reactionOutcomeRecovering/resolving

14)

reactionmeddraversionpt22.1ReactionDisturbance in attentionOutcomeRecovering/resolving

15)

reactionmeddraversionpt22.1ReactionDrug interactionOutcomeUnknown

16)

reactionmeddraversionpt22.1ReactionOff label useOutcomeUnknown

17)

reactionmeddraversionpt22.1ReactionAngioedemaOutcomeRecovering/resolving

Drug

1)

drugcharacterization3medicinalproductPREGABALIN.drugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb300drugcumulativedosageunit003drugdosagetext DOSE HAS BEEN ADJUSTED, 300 MG DOSE FROM 01-DEC-2013,100MG IN THE MORNING 200MG ... drugadministrationroute048drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate01/12/2013actiondrug5drugadditional3

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application Number ANDA209357, ANDA206912, NDA209501, ANDA203459, ANDA212865, ANDA091157, ANDA20762 ... Brand NamePREGABALIN, LYRICA CR, LYRICAGeneric NamePREGABALINManufacturers MSN LABORATORIES PRIVATE LIMITED, Camber Pharmaceuticals, Inc., Parke-Davis Div ... product_ndc 69539-011, 69539-012, 69539-013, 69539-014, 69539-015, 69539-016, 69539-017, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 1988974, 1988977 ... spl_id 6a062096-6569-45c1-9184-11e9973cc3c8, 241c4b7e-f719-4828-8639-ea613b8a6583, df98 ... spl_set_id 993bedd3-2f7c-40ff-87dc-8a55c6c7a3c7, 241c4b7e-f719-4828-8639-ea613b8a6583, 2d83 ... Package NDC 69539-011-90, 69539-011-99, 69539-011-11, 69539-011-06, 69539-012-90, 69539-012- ... UNII55JG375S6M

2)

drugcharacterization2medicinalproductSERTRALINE

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

3)

drugcharacterization3medicinalproductPROPRANOLOLdrugauthorizationnumb55387drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

4)

drugcharacterization1medicinalproductCLONAZEPAM.drugauthorizationnumb077147drugdosagetextAS NECESSARY, RARELY USEDdrugindicationANXIETYactiondrug5drugadditional3

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

5)

drugcharacterization3medicinalproductOLANZAPINE.drugauthorizationnumb27721drugindicationSLEEP DISORDERactiondrug1drugadditional1

activesubstance

activesubstancenameOLANZAPINE

openFDA Info on Medication

Application Number ANDA204319, ANDA201588, ANDA076255, NDA020592, NDA021086, NDA021253, ANDA090798, ... Brand NameOLANZAPINE, ZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULARGeneric NameOLANZAPINEManufacturers Virtus Pharmaceuticals, LLC, Sandoz Inc, Dr. Reddy's Laboratories Inc., Eli Lill ... product_ndc 69543-380, 69543-381, 69543-382, 69543-383, 69543-384, 69543-385, 0781-9105, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 200034, 283639, 312077, 312078, 312079, 314154, 485968, 153046, 153047, 153048, ... spl_id a6c0f6d1-1550-41e3-e053-2a95a90aa46f, a0f9cb84-1dee-4dc5-96b7-ce259903b940, 06a3 ... spl_set_id 6a5db723-0f21-417e-a95c-cf0c438e8b44, c44a96cc-817d-4eb5-a13a-00977f76e666, d474 ... Package NDC 69543-380-30, 69543-380-90, 69543-381-30, 69543-381-90, 69543-382-30, 69543-382- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

summary

narrativeincludeclinicalCASE EVENT DATE: 20131201

Report Duplicate

duplicatesourceACCORDduplicatenumbGB-ACCORD-023311

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use