Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10214593primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received03/06/2014receiptdateformat102Date Last Updated14/07/2014fulfillexpeditecriteria1companynumbJP-GLAXOSMITHKLINE-B0998490Aduplicate1

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbJP-GLAXOSMITHKLINE-B0998490A

Primary Source

reportercountryJPqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age33Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionBlood potassium decreasedOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionBlood sodium decreasedOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionInfectionOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionAlanine aminotransferase increasedOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionSuicide attemptOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.1ReactionC-reactive protein increasedOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionWhite blood cell count increasedOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionAgitationOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.1ReactionAspartate aminotransferase increasedOutcomeUnknown

10)

reactionmeddraversionpt17.1ReactionOverdoseOutcomeUnknown

11)

reactionmeddraversionpt17.1ReactionGaze palsyOutcomeRecovered/resolved

12)

reactionmeddraversionpt17.1ReactionUnresponsive to stimuliOutcomeRecovered/resolved

13)

reactionmeddraversionpt17.1ReactionNeutrophil count increasedOutcomeUnknown

14)

reactionmeddraversionpt17.1ReactionRestlessnessOutcomeRecovered/resolved

15)

reactionmeddraversionpt17.1ReactionScreamingOutcomeRecovered/resolved

16)

reactionmeddraversionpt17.1ReactionAltered state of consciousnessOutcomeRecovered/resolved

17)

reactionmeddraversionpt17.1ReactionPyrexiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLAMICTALdrugauthorizationnumb020241drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100MG TWICE PER DAYdrugdosageformTABLETdrugadministrationroute048drugindicationMOOD SWINGS

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id836ca780-3d75-4304-aded-c36bf096205d, e77aba1a-7ae8-42ef-b6d7-4db47796bd0espl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... 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

2)

drugcharacterization1medicinalproductLAMICTALdrugauthorizationnumb020241drugstructuredosagenumb3500drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationSUICIDE ATTEMPTdrugstartdateformat102drugstartdate23/05/2014actiondrug5

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id836ca780-3d75-4304-aded-c36bf096205d, e77aba1a-7ae8-42ef-b6d7-4db47796bd0espl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... 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)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb14drugstructuredosageunit032drugdosageformTABLETdrugadministrationroute048drugindicationSUICIDE ATTEMPTdrugstartdateformat102drugstartdate23/05/2014

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

4)

drugcharacterization2medicinalproductSEROQUELdrugstructuredosagenumb250drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationSUICIDE ATTEMPT

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294, 37cb4cbf-8192-4921-b17c-e562467fc018spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

5)

drugcharacterization2medicinalproductAMOBANdrugstructuredosagenumb15drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationSUICIDE ATTEMPT

activesubstance

activesubstancenameZOPICLONE

6)

drugcharacterization2medicinalproductROZEREMdrugstructuredosagenumb8drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationMOOD SWINGS

activesubstance

activesubstancenameRAMELTEON

openFDA Info on Medication

Application NumberNDA021782Brand NameROZEREMGeneric NameRAMELTEONManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-805Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMELTEONRXCUI577348, 603162spl_idab007fde-2fd9-4b4c-9b1a-39b9e3e2fe0bspl_set_id9de82310-70e8-47b9-b1fc-6c6848b99455Package NDC64764-805-30, 64764-805-10, 64764-805-22NUIN0000175743, N0000000250Established Pharmacologic ClassMelatonin Receptor Agonist [EPC]Mechanism of ActionMelatonin Receptor Agonists [MoA]UNII901AS54I69

7)

drugcharacterization2medicinalproductLENDORMINdrugstructuredosagenumb.75drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationSUICIDE ATTEMPT

activesubstance

activesubstancenameBROTIZOLAM

8)

drugcharacterization2medicinalproductROZEREMdrugstructuredosagenumb48drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationSUICIDE ATTEMPTdrugstartdateformat102drugstartdate23/05/2014

activesubstance

activesubstancenameRAMELTEON

openFDA Info on Medication

Application NumberNDA021782Brand NameROZEREMGeneric NameRAMELTEONManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-805Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMELTEONRXCUI577348, 603162spl_idab007fde-2fd9-4b4c-9b1a-39b9e3e2fe0bspl_set_id9de82310-70e8-47b9-b1fc-6c6848b99455Package NDC64764-805-30, 64764-805-10, 64764-805-22NUIN0000175743, N0000000250Established Pharmacologic ClassMelatonin Receptor Agonist [EPC]Mechanism of ActionMelatonin Receptor Agonists [MoA]UNII901AS54I69

9)

drugcharacterization2medicinalproductWYPAXdrugstructuredosagenumb3drugstructuredosageunit032drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate24/05/2014

activesubstance

activesubstancenameLORAZEPAM

summary

narrativeincludeclinicalCASE EVENT DATE: 20140523