Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10387028Date Received14/08/2014transmissiondate26/03/2015serious1Date Last Updated14/08/2014primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age18Unit of Onset AgeyearsWeight74.84SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionAccident

2)

reactionmeddraversionpt17.1ReactionPain

3)

reactionmeddraversionpt17.1ReactionStargardt^s disease

4)

reactionmeddraversionpt17.1ReactionSuicidal ideation

5)

reactionmeddraversionpt17.1ReactionPanic attack

6)

reactionmeddraversionpt17.1ReactionRoad traffic accident

7)

reactionmeddraversionpt17.1ReactionPost-traumatic neck syndrome

8)

reactionmeddraversionpt17.1ReactionDependence

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugindicationACNEdrugtreatmentduration6drugtreatmentdurationunit802drugadditional2

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: 20140813