Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11316313primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessdeath1receivedateformat102Date Received28/07/2015receiptdateformat102Date Last Updated27/08/2015fulfillexpeditecriteria1companynumbPHHY2015US089917duplicate1

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2015US089917

Primary Source

reportercountryCHqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionCompleted suicideOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductLAZANDAdrugstructuredosagenumb400drugstructuredosageunit004drugdosagetext400 UG, PRN (2 SQUIRTS IN THE NOSTRILS FOUR TIMES A DAY, AS NEEDED)drugdosageformNASAL SPRAYdrugadministrationroute045drugindicationPAINdrugstartdateformat102drugstartdate15/05/2015

activesubstance

activesubstancenameFENTANYL CITRATE

openFDA Info on Medication

Application NumberNDA022569Brand NameLAZANDAGeneric NameFENTANYLManufacturersWest Therapeutic Development LLCproduct_ndc71500-110, 71500-140, 71500-130Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsFENTANYL CITRATERXCUI1115573, 1115575, 1115577, 1115579, 1729320, 1729322spl_idbe24d79a-2287-2b3a-e053-2a95a90a8243spl_set_id73f38bde-2132-2b5a-e053-2a91aa0a6efbPackage NDC71500-140-01, 71500-130-01, 71500-110-01UNIIMUN5LYG46H

2)

drugcharacterization1medicinalproductPAMELORdrugdosageformCAPSULEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameNORTRIPTYLINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018013Brand NamePAMELORGeneric NameNORTRIPTYLINE HYDROCHLORIDEManufacturersSpecGx LLCproduct_ndc0406-9910, 0406-9911, 0406-9912, 0406-9913Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNORTRIPTYLINE HYDROCHLORIDERXCUI198045, 198046, 198047, 209329, 209339, 209350, 209391, 317136spl_idad133e62-40fe-496f-8bb4-575c5102e781spl_set_ide17dc299-f52d-414d-ab6e-e809bd6f8acbPackage NDC0406-9910-03, 0406-9911-03, 0406-9912-03, 0406-9913-03UNII00FN6IH15D

3)

drugcharacterization1medicinalproductBACLOFEN.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

4)

drugcharacterization1medicinalproductOXYCONTINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, TIDdrugdosageformEXTENDED RELEASE TABLETdrugadministrationroute048drugindicationPAIN

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id9686aad4-8ab9-47da-a74e-23e1d2496c2espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

5)

drugcharacterization1medicinalproductVALIUMdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, TID (INCREASED UP TO 10 MG)drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc., Waylis Therapuetics LLCproduct_ndc0140-0004, 0140-0005, 0140-0006, 80725-004, 80725-005, 80725-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMRXCUI104699, 104700, 104701, 197589, 197590, 197591spl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14, dc250376-39ef-2207-e053-2a95a90a4901spl_set_id554baee5-b171-4452-a50a-41a0946f956c, 260e2041-2bb3-482f-850e-b5d47a7bdbe6Package NDC 0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14, 80725-004- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

6)

drugcharacterization1medicinalproductFIORICETdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BID (50 MG-325 MG-40 MG)drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberANDA040885Brand NameFIORICETGeneric NameBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEManufacturersActavis Pharma, Inc.product_ndc52544-080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, BUTALBITAL, CAFFEINERXCUI889520, 1432261spl_id14ca4151-a727-4708-8e35-8eb08e175db8spl_set_idc018be7d-f7b8-45e2-97b8-8e7a71740657Package NDC52544-080-01NUIN0000175693, M0002177, N0000175739, N0000175729, N0000175790, M0023046Established Pharmacologic ClassBarbiturate [EPC], Central Nervous System Stimulant [EPC], Methylxanthine [EPC]Chemical StructureBarbiturates [CS], Xanthines [CS]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]UNII362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E

7)

drugcharacterization1medicinalproductOPANAdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 MG, BIDdrugdosageformEXTENDED RELEASE TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOXYMORPHONE HYDROCHLORIDE

8)

drugcharacterization1medicinalproductCAMBIAdrugauthorizationnumb020142drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, (ONE UNIT BY MOUTH AT ONSET OF MIGRAINE)drugdosageformPOWDER FOR ORAL SOLUTIONdrugadministrationroute048drugindicationMIGRAINE

activesubstance

activesubstancenameDICLOFENAC POTASSIUM

openFDA Info on Medication

Application NumberNDA022165Brand NameCAMBIAGeneric NameDICLOFENAC POTASSIUMManufacturersAssertio Therapeutics, Inc.product_ndc13913-011, 13913-012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDICLOFENAC POTASSIUMRXCUI859063, 859066spl_id90212a85-4b76-4a51-a22b-15016a491238, e8123abd-304e-4001-8ff1-01f5619ba30fspl_set_idc5856c21-f322-11e3-ac10-0800200c9a66, d249ced1-4ca0-4f57-adcb-23440f58f659Package NDC13913-011-01, 13913-011-19, 13913-012-01, 13913-012-03, 13913-012-02UNIIL4D5UA6CB4

9)

drugcharacterization1medicinalproductVICODINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, TID (HYDROCODONE 10 MG-ACETAMINOPHEN 325 MG)drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

10)

drugcharacterization1medicinalproductLUNESTAdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

11)

drugcharacterization1medicinalproductFENTORAdrugstructuredosagenumb800drugstructuredosageunit004drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext800 UG, QIDdrugdosageformBUCCAL TABLETdrugadministrationroute002drugindicationPAIN

activesubstance

activesubstancenameFENTANYL CITRATE

openFDA Info on Medication

Application NumberNDA021947Brand NameFENTORAGeneric NameFENTANYLManufacturersCephalon, Inc.product_ndc63459-541, 63459-542, 63459-544, 63459-546, 63459-548Product TypeHUMAN PRESCRIPTION DRUGRouteBUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATERXCUI668363, 668364, 668365, 668366, 668367, 668622, 668624, 668626, 668628, 668630spl_id51702896-c8d3-4d22-b515-7dbf3eb37e9cspl_set_id8f549d95-985b-f783-1ebb-ef57bd2ecb05Package NDC 63459-541-04, 63459-541-28, 63459-542-04, 63459-542-28, 63459-544-04, 63459-544- ... UNIIMUN5LYG46H

12)

drugcharacterization1medicinalproductZOLPIDEMdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameZOLPIDEM\ZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_ide4a5e984-a50b-4f1e-a50d-b1acd2b34d52spl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

summary

narrativeincludeclinicalCASE EVENT DATE: 20150519