Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10416003primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnessdeath1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received28/08/2014receiptdateformat102Date Last Updated28/08/2014fulfillexpeditecriteria1companynumbUS-009507513-2010SP012801duplicate1

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-2010SP012801

Primary Source

reportercountryUSqualification4

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight58.51SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPulmonary embolismOutcomeFatal

2)

reactionmeddraversionpt17.1ReactionLacerationOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionHypoxiaOutcomeFatal

4)

reactionmeddraversionpt17.1ReactionBlood glucose increasedOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionBlood potassium decreasedOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionTroponin I increasedOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionBlood calcium decreasedOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionCardio-respiratory arrestOutcomeFatal

9)

reactionmeddraversionpt17.1ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductARMOUR THYROIDdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugindicationTHYROID DISORDERdrugstartdateformat102drugstartdate31/10/2006drugenddateformat102drugenddate28/12/2006

activesubstance

activesubstancenameTHYROID, PORCINE\THYROID, UNSPECIFIED

openFDA Info on Medication

Brand NameARMOUR THYROIDGeneric NameTHYROID, PORCINEManufacturersAllergan, Inc.product_ndc 0456-0457, 0456-0458, 0456-0459, 0456-0460, 0456-0461, 0456-0462, 0456-0463, 045 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTHYROID, PORCINERXCUI 198278, 208534, 208535, 208540, 208543, 208544, 208545, 208547, 208549, 208551, ... spl_idf51844cf-33ae-4b36-ba2c-21c53e45847dspl_set_id56b41079-60db-4256-9695-202b3a65d13dPackage NDC 0456-0457-01, 0456-0458-01, 0456-0458-11, 0456-0458-63, 0456-0459-01, 0456-0459- ... UNII6RV024OAUQ

2)

drugcharacterization1medicinalproductNUVARINGdrugauthorizationnumb021187drugdosageformVaginal RingdrugindicationMICTURITION URGENCYactiondrug4

activesubstance

activesubstancenameETHINYL ESTRADIOL\ETONOGESTREL

openFDA Info on Medication

3)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNK UNK, PRNdrugindicationINSOMNIAdrugstartdateformat102drugstartdate05/12/2006

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)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugindicationTHYROID DISORDERdrugstartdateformat102drugstartdate29/12/2006drugenddateformat102drugenddate02/01/2007

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

5)

drugcharacterization1medicinalproductNUVARINGdrugauthorizationnumb021187drugdosageformVaginal Ringdrugadministrationroute067drugindicationPOLLAKIURIAdrugstartdateformat102drugstartdate24/10/2006drugenddateformat102drugenddate02/01/2007actiondrug4

activesubstance

activesubstancenameETHINYL ESTRADIOL\ETONOGESTREL

openFDA Info on Medication

6)

drugcharacterization2medicinalproductCOMBIPATCHdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextTAKEN UNTIL 31OCT2006 OR LATERdrugindicationBLADDER DISORDERdrugstartdateformat602drugstartdate//2003

activesubstance

activesubstancenameESTRADIOL\NORETHINDRONE ACETATE

summary

narrativeincludeclinicalCASE EVENT DATE: 20070102