Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11795033primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate05/03/2016reporttype1serious1seriousnessdeath1seriousnessother1receivedateformat102Date Received02/12/2015receiptdateformat102Date Last Updated02/12/2015fulfillexpeditecriteria1companynumbUS-TEVA-612855USAduplicate1

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-612855USA

Primary Source

reportercountryUSqualification3literaturereference BISHOP-FREEMAN SC, MILLER A, HENSEL EM, WINECKER RE. POSTMORTEM METAXALONE (SKEL ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age26Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionIntentional overdoseOutcomeFatal

2)

reactionmeddraversionpt18.1ReactionCompleted suicideOutcomeFatal

3)

reactionmeddraversionpt18.1ReactionToxicity to various agentsOutcomeFatal

Drug

1)

drugcharacterization2medicinalproductCITALOPRAMdrugadministrationroute065

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, NDA215428, ANDA077534, ANDA077042, ANDA077031, ANDA07728 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Almatica Pharma L ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 52427-691, 69097-822, 69097-823, 690 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDE, CITALOPRAMRXCUI200371, 283672, 309314, 309313, 2591786, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 3b571c67-5234-44ad-8276-e29b1ceabec3, bde4 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 2f81 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36, 0DHU5B8D6VNUIN0000175696, N0000000109Established Pharmacologic ClassSerotonin Reuptake Inhibitor [EPC]Mechanism of ActionSerotonin Uptake Inhibitors [MoA]

2)

drugcharacterization2medicinalproductLAMOTRIGINE.drugadministrationroute065

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application Number ANDA200672, ANDA206382, ANDA213949, ANDA078956, ANDA077633, ANDA078009, ANDA0767 ... Brand NameLAMOTRIGINE, LAMICTAL, LAMICTAL ODT, LAMOTRIGINE KIT, LAMICTAL XR, SUBVENITEGeneric Name LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAM ... Manufacturers Actavis Pharma, Inc., Dr. Reddys Laboratories Inc., Yiling Pharmaceutical, Inc., ... product_ndc 0228-1410, 0228-1435, 0228-1422, 0228-1453, 0228-1638, 0228-1580, 43598-550, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 850087, 850091, 900156, 900164, 1098608, 1146690, 103968, 198430, 252478, 252479 ... spl_id 056504f1-1818-40cb-b75a-33fd1d907b04, c7aa46de-c5c5-2e12-e053-2a95a90af492, d627 ... spl_set_id 87beaf22-593d-4170-bb58-332c615ef90d, 54ea1ec3-876b-4d3a-a92b-1a6d70951de0, f7de ... Package NDC 0228-1410-03, 0228-1435-03, 0228-1422-03, 0228-1453-03, 0228-1638-03, 0228-1580- ... NUIN0000175753, N0000008486, N0000175751, N0000187061, N0000000191Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of Action Organic Cation Transporter 2 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor ... UNIIU3H27498KS

3)

drugcharacterization1medicinalproductESZOPICLONE.drugauthorizationnumb091169drugadministrationroute065

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

4)

drugcharacterization1medicinalproductSKELAXINdrugadministrationroute065

activesubstance

activesubstancenameMETAXALONE

openFDA Info on Medication

Application NumberNDA013217Brand NameSKELAXINGeneric NameMETAXALONEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc60793-136Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETAXALONERXCUI351254, 352277spl_id69cd3a38-0558-4208-8fa8-487bde725a3espl_set_id7a4163f2-c553-4d14-7e98-d14c5c7f772aPackage NDC60793-136-01, 60793-136-05NUIN0000175730Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]UNII1NMA9J598Y