Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10369510primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate20/07/2015reporttype2serious1seriousnessdeath1seriousnessother1receivedateformat102Date Received07/08/2014receiptdateformat102Date Last Updated31/03/2015fulfillexpeditecriteria1companynumbUS-GILEAD-2014-0111414duplicate1

Report Duplicate

duplicatesourceGILEADduplicatenumbUS-GILEAD-2014-0111414

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age73Unit of Onset Ageyearspatientagegroup6SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionSepsisOutcomeFatal

2)

reactionmeddraversionpt18.0ReactionPneumoniaOutcomeFatal

3)

reactionmeddraversionpt18.0ReactionAcute respiratory failureOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductAMBRISENTANdrugauthorizationnumb022081drugdosageformTABLETdrugindicationINTERSTITIAL LUNG DISEASEactiondrug4

activesubstance

activesubstancenameAMBRISENTAN

openFDA Info on Medication

Application Number ANDA208252, ANDA210058, NDA022081, ANDA208441, ANDA210701, ANDA208354, ANDA21071 ... Brand NameAMBRISENTAN, LETAIRISGeneric NameAMBRISENTANManufacturers Actavis Pharma, Inc., Cadila Healthcare Limited, Gilead Sciences, Inc, Mylan Pha ... product_ndc 0591-2405, 0591-2406, 70771-1363, 70771-1364, 61958-0801, 61958-0802, 0378-4270, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMBRISENTANRXCUI722116, 722122, 722120, 722124spl_id 2642df14-b8bc-4f7f-8290-495ae31a279d, 10090013-5561-434a-8750-d774f51c4f29, b6b1 ... spl_set_id 32549c43-f8ff-422c-b42d-ca0877e661cf, 0e3e3320-27ac-404f-9f01-3d82696e768a, 725d ... Package NDC 0591-2405-30, 0591-2406-30, 70771-1363-3, 70771-1363-9, 70771-1363-1, 70771-1363 ... NUIN0000175581, N0000175364Established Pharmacologic ClassEndothelin Receptor Antagonist [EPC]Mechanism of ActionEndothelin Receptor Antagonists [MoA]UNIIHW6NV07QEC

2)

drugcharacterization2medicinalproductWARFARIN

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

3)

drugcharacterization2medicinalproductDILTIAZEM

activesubstance

activesubstancenameDILTIAZEM

4)

drugcharacterization2medicinalproductFUROSEMIDE.

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

5)

drugcharacterization1medicinalproductAMBRISENTANdrugauthorizationnumb022081drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugdosageformTABLETdrugadministrationroute065drugindicationPULMONARY HYPERTENSIONdrugstartdateformat102drugstartdate17/06/2014drugenddateformat102drugenddate29/07/2014actiondrug4

activesubstance

activesubstancenameAMBRISENTAN

openFDA Info on Medication

Application Number ANDA208252, ANDA210058, NDA022081, ANDA208441, ANDA210701, ANDA208354, ANDA21071 ... Brand NameAMBRISENTAN, LETAIRISGeneric NameAMBRISENTANManufacturers Actavis Pharma, Inc., Cadila Healthcare Limited, Gilead Sciences, Inc, Mylan Pha ... product_ndc 0591-2405, 0591-2406, 70771-1363, 70771-1364, 61958-0801, 61958-0802, 0378-4270, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMBRISENTANRXCUI722116, 722122, 722120, 722124spl_id 2642df14-b8bc-4f7f-8290-495ae31a279d, 10090013-5561-434a-8750-d774f51c4f29, b6b1 ... spl_set_id 32549c43-f8ff-422c-b42d-ca0877e661cf, 0e3e3320-27ac-404f-9f01-3d82696e768a, 725d ... Package NDC 0591-2405-30, 0591-2406-30, 70771-1363-3, 70771-1363-9, 70771-1363-1, 70771-1363 ... NUIN0000175581, N0000175364Established Pharmacologic ClassEndothelin Receptor Antagonist [EPC]Mechanism of ActionEndothelin Receptor Antagonists [MoA]UNIIHW6NV07QEC

6)

drugcharacterization2medicinalproductAMIODARONE

activesubstance

activesubstancenameAMIODARONE

7)

drugcharacterization2medicinalproductESZOPICLONE.

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

8)

drugcharacterization2medicinalproductLOVASTATIN.

activesubstance

activesubstancenameLOVASTATIN

openFDA Info on Medication

Application NumberANDA078296, ANDA075991, NDA021316, ANDA075551, ANDA075636Brand NameLOVASTATIN, ALTOPREVGeneric NameLOVASTATINManufacturers Lupin Pharmaceuticals, Inc., Carlsbad Technology, Inc., Covis Pharma US, Inc, Te ... product_ndc 68180-467, 68180-468, 68180-469, 61442-141, 61442-142, 61442-143, 70515-628, 705 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOVASTATINRXCUI197903, 197904, 197905, 359731, 359732, 433849, 884383, 997006, 997007spl_id c604f04e-6251-4b55-9cf3-6b534605137b, b18075c3-0ee9-12af-e053-2a95a90a9d89, 6ae2 ... spl_set_id df7ddf4f-d569-431e-81f1-9129d7043150, 0a680e13-0356-4e08-a7fe-78b96ba51b9d, 8c0d ... Package NDC 68180-467-09, 68180-467-07, 68180-467-01, 68180-467-03, 68180-467-05, 68180-468- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNII9LHU78OQFD

9)

drugcharacterization2medicinalproductBROVANA

activesubstance

activesubstancenameARFORMOTEROL TARTRATE

openFDA Info on Medication

Application NumberNDA021912Brand NameBROVANAGeneric NameARFORMOTEROL TARTRATEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-911Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsARFORMOTEROL TARTRATERXCUI668956, 695935spl_id2958732d-0046-49fc-8f28-b36959252832spl_set_id7134ae7c-6c64-470d-ab4e-81e35413b839Package NDC 63402-911-04, 63402-911-64, 63402-911-01, 63402-911-30, 63402-911-02, 63402-911- ... UNII5P8VJ2I235