Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10372992serious1Date Last Updated25/11/2014receiptdateformat102companynumbUS-MYLANLABS-2014M1000589occurcountryUSseriousnessother1duplicate1Date Received08/08/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age32Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionVaginal haemorrhageOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionExposure during pregnancyOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductANTIHYPERTENSIVESdrugdosagetextUNKdrugindicationHYPERTENSIONactiondrug4

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

2)

drugcharacterization2medicinalproductORAL CONTRACEPTIVE NOSdrugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationCONTRACEPTIONdrugenddateformat602drugenddate//2014actiondrug1

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

3)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb11200drugcumulativedosageunit003drugdosagetext80 MG, QDdrugdosageformCAPSULEdrugstartdateformat102drugstartdate22/01/2014drugenddateformat102drugenddate04/07/2014actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20140612

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014M1000589

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use