Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID12401734primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate09/11/2016reporttype1serious1seriousnessdeath1seriousnesshospitalization1receivedateformat102Date Received25/05/2016receiptdateformat102Date Last Updated19/07/2016fulfillexpeditecriteria1companynumbUS-INSYS THERAPEUTICS, INC-INS201605-000218duplicate1

Report Duplicate

duplicatesourceINSYSduplicatenumbUS-INSYS THERAPEUTICS, INC-INS201605-000218

Primary Source

reportercountryUSqualification3literaturereference MOWRY J,SPYKER D,BROOKS D,MCMILLAN N,SCHAUBEN J. 2014 ANNUAL REPORT OF THE AMERI ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age42Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionHyperthermiaOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionMultiple organ dysfunction syndromeOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionRenal failureOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionAnoxiaOutcomeUnknown

5)

reactionmeddraversionpt19.1ReactionDisseminated intravascular coagulationOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionCyanosisOutcomeUnknown

7)

reactionmeddraversionpt19.1ReactionToxicity to various agentsOutcomeFatal

8)

reactionmeddraversionpt19.1ReactionTachycardiaOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionAcute respiratory distress syndromeOutcomeUnknown

10)

reactionmeddraversionpt19.1ReactionHypertensionOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductCALAN SR

activesubstance

activesubstancenameVERAPAMIL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019152Brand NameCALAN SRGeneric NameVERAPAMIL HYDROCHLORIDEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-2712, 0025-1901, 0025-1911, 0025-1891, 0025-2818, 0025-2924Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVERAPAMIL HYDROCHLORIDERXCUI897640, 897649, 897659, 897661, 897676, 897680spl_id93e315dd-1373-4922-8117-994dc7c04833spl_set_idacb6e57b-af44-432f-a4de-a293a2e20121Package NDC 0025-1901-31, 0025-1911-31, 0025-1891-31, 0025-2712-31, 0025-2818-31, 0025-2924- ... UNIIV3888OEY5R

2)

drugcharacterization2medicinalproductLEVOTHYROXINE.

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

3)

drugcharacterization2medicinalproductSODIUM BICARBONATE INFUSION

4)

drugcharacterization2medicinalproductALBUTEROL.

activesubstance

activesubstancenameALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

5)

drugcharacterization2medicinalproductTRAZODONE

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

6)

drugcharacterization2medicinalproductACETAMINOPHEN/HYDROCODONE

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE

7)

drugcharacterization1medicinalproductHYDROMORPHONEdrugindicationCOMPLETED SUICIDE

activesubstance

activesubstancenameHYDROMORPHONE

8)

drugcharacterization1medicinalproductFENTANYL.drugauthorizationnumb202788drugadministrationroute065drugindicationCOMPLETED SUICIDE

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]

9)

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

10)

drugcharacterization2medicinalproductTAMSULOSIN

activesubstance

activesubstancenameTAMSULOSIN

11)

drugcharacterization2medicinalproductLEVOCETIRIZINE

activesubstance

activesubstancenameLEVOCETIRIZINE

openFDA Info on Medication

Application NumberANDA211983Brand NameLEVOCETIRIZINEGeneric NameLEVOCETIRIZINE DIHYDROCHLORIDEManufacturersWalgreen Companyproduct_ndc0363-2241Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOCETIRIZINE DIHYDROCHLORIDERXCUI855172spl_ide7550654-1089-4b1b-a464-14125cc1aac8spl_set_iddb38f528-6cf4-4e3c-89b9-8bbadbb1d0a1Package NDC0363-2241-76UNIISOD6A38AGA

12)

drugcharacterization2medicinalproductALENDRONATE

activesubstance

activesubstancenameALENDRONATE SODIUM

openFDA Info on Medication

Application NumberANDA090258Brand NameALENDRONATEGeneric NameALENDRONATE SODIUM, ALENDRONATE SODIUM TABLETManufacturers Virtus Pharmaceuticals, Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd., Mar ... product_ndc69543-130, 69543-131, 60723-205, 60723-207, 10135-718, 10135-719Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALENDRONATE SODIUMRXCUI904396, 904431spl_id d42c7c03-3f82-6a67-e053-2995a90a6ebc, d0f979c3-26f8-2393-e053-2995a90a0e1d, ccc0 ... spl_set_id 5c49d7fc-c76a-40c9-8c43-68b731230f0e, a24fd39c-34a7-4de2-9439-781e612189ca, b634 ... Package NDC 69543-130-04, 69543-130-12, 69543-130-20, 69543-131-04, 69543-131-12, 69543-131- ... UNII2UY4M2U3RA

13)

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

14)

drugcharacterization1medicinalproductBUTALBITALdrugindicationCOMPLETED SUICIDE

activesubstance

activesubstancenameBUTALBITAL

summary

narrativeincludeclinicalCASE EVENT DATE: 20140605