Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11322366primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessdeath1receivedateformat102Date Received28/07/2015receiptdateformat102Date Last Updated28/07/2015fulfillexpeditecriteria1companynumbDEP_03240_2015duplicate1

Report Duplicate

duplicatesourceDEPOMEDduplicatenumbDEP_03240_2015

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsWeight136.53SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionCompleted suicide

Drug

1)

drugcharacterization1medicinalproductLAZANDAdrugstructuredosagenumb400drugstructuredosageunit004drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 SQUIRTS IN THE NOSTRILS FOUR TIMES A DAY, AS NEEDEDdrugadministrationroute045drugindicationOFF LABEL USEdrugstartdateformat102drugstartdate15/05/2015

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)

drugcharacterization1medicinalproductVALIUMdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextINCREASED UP TO 10 MG TABLET, THREE TIMES A DAY ORALdrugdosageformCOATED TABLETdrugadministrationroute048drugindicationPRODUCT 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

3)

drugcharacterization1medicinalproductOPANAdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOXYMORPHONE HYDROCHLORIDE

4)

drugcharacterization1medicinalproductPAMELORdrugadministrationroute048drugindicationPRODUCT 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

5)

drugcharacterization1medicinalproductFENTORAdrugstructuredosagenumb800drugstructuredosageunit004drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute002drugindicationPAIN

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

6)

drugcharacterization1medicinalproductCAMBIAdrugauthorizationnumb022165drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, ONE UNIT BY MOUTH AT ONSET OF MIGRAINE ORALdrugadministrationroute048drugindicationMIGRAINE

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

7)

drugcharacterization1medicinalproductLAZANDAdrugstructuredosagenumb400drugstructuredosageunit004drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 SQUIRTS IN THE NOSTRILS FOUR TIMES A DAY, AS NEEDEDdrugadministrationroute045drugindicationPAINdrugstartdateformat102drugstartdate15/05/2015

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

8)

drugcharacterization1medicinalproductLUNESTAdrugadministrationroute048drugindicationPRODUCT 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

9)

drugcharacterization1medicinalproductHYDROCODONE BITARTRATE AND ACETAMINOPHENdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext(HYDROCODONE 10 MG-ACETAMINOPHEN 325 MG, ONE TABLET THREE TIMES A DAY ORAL)drugdosageformCOATED TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application Number ANDA211023, ANDA202214, ANDA206245, ANDA203863, ANDA206869, ANDA202991, ANDA2077 ... Brand NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN, LORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturers Eywa Pharma Inc, Tris Pharma Inc, Novel Laboratories, Inc., Epic Pharma, LLC, Am ... product_ndc 71930-027, 27808-035, 27808-036, 27808-037, 40032-356, 40032-358, 40032-357, 428 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, HYDROCODONE BITARTRATERXCUI856940, 856999, 857002, 857005, 856987, 856980, 856992, 1044427, 857391, 1442445spl_id 6b16103c-b56a-461d-9875-b7eeb31411f6, 8ea12d79-1c1f-4c5e-a611-475226dd0285, 102f ... spl_set_id adb37532-aa19-48a2-95a1-8c92a6ce8651, d4caec6d-4af2-4f1c-9add-c0c948b83b16, 7a89 ... Package NDC 71930-027-43, 27808-035-01, 27808-035-02, 27808-035-03, 27808-036-01, 27808-036- ... UNII362O9ITL9D, NO70W886KK

10)

drugcharacterization1medicinalproductOXYCONTINdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextINCREASED UP TO 40 MG TABLETS, ONE TABLET THREE TIMES A DAYdrugdosageformCOATED 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

11)

drugcharacterization1medicinalproductFIORICETdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG-325 MG-40 MG ORALdrugadministrationroute048drugindicationPRODUCT 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

12)

drugcharacterization1medicinalproductBACLOFEN.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT 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

13)

drugcharacterization1medicinalproductZOLPIDEMdrugadministrationroute048drugindicationPRODUCT 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