Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11382471primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessdeath1receivedateformat102Date Received14/08/2015receiptdateformat102Date Last Updated20/08/2015fulfillexpeditecriteria1companynumbUS-PURDUE-USA-2015-0125505duplicate1

Report Duplicate

duplicatesourcePURDUEduplicatenumbUS-PURDUE-USA-2015-0125505

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsWeight136.51SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionCompleted suicideOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductVALIUMdrugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, TIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductOPANAdrugbatchnumbUNKNOWNdrugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameOXYMORPHONE HYDROCHLORIDE

3)

drugcharacterization1medicinalproductHYDROCODONE BITARTRATE AND ACETAMINOPHENdrugbatchnumbUNKNOWNdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10/325 MG, TIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

4)

drugcharacterization1medicinalproductFENTANYL CITRATE.drugbatchnumbUNKNOWNdrugstructuredosagenumb400drugstructuredosageunit004drugdosagetext400 MCG, UNKdrugadministrationroute045drugindicationMIGRAINEdrugstartdateformat102drugstartdate15/05/2015actiondrug4

activesubstance

activesubstancenameFENTANYL CITRATE

openFDA Info on Medication

Application Number NDA019115, NDA020747, NDA019101, NDA021947, ANDA078907, ANDA212086, ANDA210762, ... Brand NameFENTANYL CITRATE, FENTANYL BUCCAL, ACTIQGeneric NameFENTANYL CITRATEManufacturers Hospira, Inc., Teva Pharmaceuticals USA, Inc., Hikma Pharmaceuticals USA Inc., M ... product_ndc 0409-9093, 0409-9094, 0093-7865, 0093-7866, 0093-7867, 0093-7868, 0093-7869, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, TRANSMUCOSAL, BUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATERXCUI 1735003, 310293, 310294, 310295, 310297, 313992, 313993, 1735007, 1735008, 17350 ... spl_id 268fba14-76ac-4b8d-810c-124f37228d91, dfb04705-85fe-46ee-b735-4e4bfc7f8063, 4b40 ... spl_set_id 1ed25b2c-334e-4021-ada1-3396f07630dc, 78221eab-66fd-4cd8-9c81-af52eb83671c, ce5d ... Package NDC 0409-9093-09, 0409-9093-11, 0409-9094-09, 0409-9094-11, 0093-7865-19, 0093-7865- ... UNIIMUN5LYG46H

5)

drugcharacterization1medicinalproductFIORICETdrugbatchnumbUNKNOWNdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext50/325/40 MG, BIDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

6)

drugcharacterization1medicinalproductLUNESTAdrugbatchnumbUNKNOWNdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, AC PMdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

7)

drugcharacterization1medicinalproductBACLOFEN.drugbatchnumbUNKNOWNdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, Q6Hdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

8)

drugcharacterization1medicinalproductOXYCONTINdrugbatchnumbUNKNOWNdrugauthorizationnumb022272drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, TIDdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationPAINactiondrug5drugrecurreadministration3

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

9)

drugcharacterization1medicinalproductZOLPIDEM TARTRATE.drugbatchnumbUNKNOWNdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, AC PMdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application Number ANDA078148, NDA021997, ANDA213592, ANDA076410, ANDA077214, ANDA204170, NDA021774 ... Brand Name ZOLPIDEM TARTRATE EXTENDED-RELEASE, EDLUAR, ZOLPIDEM TARTRATE, ZOLPIDEM, ZOLPIMI ... Generic NameZOLPIDEM TARTRATEManufacturers Par Pharmaceutical, Inc., Meda Pharmaceuticals Inc., Breckenridge Pharmaceutical ... product_ndc 10370-116, 10370-117, 0037-6010, 0037-6050, 51991-981, 51991-982, 0093-0073, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBLINGUALActive IngredientsZOLPIDEM TARTRATERXCUI 854880, 854894, 836641, 836645, 836647, 836649, 854873, 854876, 1232194, 1232202 ... spl_id 78c500a3-0492-4838-b8d2-c9a59aa43cdd, 4adf6b2c-a6a8-48af-a04c-d903fe0d1d59, d593 ... spl_set_id 1a32885f-7e42-4558-9142-42d441bcf23d, a32884d0-85b5-11de-8a39-0800200c9a66, cbda ... Package NDC 10370-117-10, 10370-116-10, 0037-6050-30, 0037-6050-35, 0037-6050-93, 0037-6010- ... UNIIWY6W63843K

10)

drugcharacterization1medicinalproductDICLOFENAC POTASSIUM.drugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute048drugindicationMIGRAINEactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameDICLOFENAC POTASSIUM

openFDA Info on Medication

Application Number ANDA215585, ANDA215750, ANDA202964, NDA022165, ANDA075229, ANDA076561, ANDA21387 ... Brand NameDICLOFENAC POTASSIUM, CAMBIA, LOFENA, CATAFLAM, ZIPSORGeneric NameDICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM TABLETSManufacturers Ingenus Pharmaceuticals, LLC, UMEDICA LABORATORIES PRIVATE LIMITED, Par Pharmace ... product_ndc 50742-279, 60290-057, 49884-905, 13913-011, 74157-007, 15370-180, 59651-353, 736 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDICLOFENAC POTASSIUMRXCUI855942, 859063, 859066, 857702, 2584350, 858342, 855944, 858346spl_id 2061d686-9ff2-4c19-9761-b4d8b4e43b05, eabdc2ba-e3ff-4664-a792-33259fff93d3, dd4c ... spl_set_id 6926444f-0dca-4aeb-812e-755a83b149f4, 1fa07fbe-3708-4200-b3ff-a920434896b6, 2d45 ... Package NDC 50742-279-01, 60290-057-01, 60290-057-02, 49884-905-24, 49884-905-52, 49884-905- ... UNIIL4D5UA6CB4

11)

drugcharacterization1medicinalproductPAMELORdrugbatchnumbUNKNOWNdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, AC PMdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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

12)

drugcharacterization1medicinalproductFENTANYL.drugbatchnumbUNKNOWNdrugstructuredosagenumb800drugstructuredosageunit004drugdosagetext800 MCG, Q6H PRNdrugadministrationroute002drugindicationPAINdrugstartdateformat102drugstartdate15/05/2015actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameFENTANYL

openFDA Info on Medication

Application NumberNDA022569, NDA202788, ANDA202097, ANDA077449, NDA021947, NDA019813, ANDA076258Brand NameLAZANDA, SUBSYS, FENTANYL SYSTEM, FENTANYL, FENTORA, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, West Therapeutics Development, LLC, Alvogen, A ... product_ndc 71500-110, 71500-140, 71500-130, 71500-001, 71500-002, 71500-004, 71500-006, 715 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, SUBLINGUAL, TRANSDERMAL, BUCCALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 1237050, 1237055, 1237057, ... spl_id be24d79a-2287-2b3a-e053-2a95a90a8243, c10a64fb-0dc8-b077-e053-2995a90a374f, d22b ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, be7670d5-b88a-13bd-e053-2995a90a2f78, 2427 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 71500-001-10, 71500-002-30, 71500-004- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

summary

narrativeincludeclinicalCASE EVENT DATE: 20150519