Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11434989serious1Date Last Updated31/08/2015receiptdateformat102seriousnessdeath1companynumbUS-MYLANLABS-2015M1028768occurcountryUSseriousnessother1duplicate1Date Received31/08/2015transmissiondate25/11/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1literaturereference CASTRO J, BILLICK S. PSYCHIATRIC PRESENTATIONS/MANIFESTATIONS OF MEDICAL ILLNESS ...

Patient

Reaction

1)

reactionmeddraversionpt18.1ReactionMoroseOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionCompleted suicideOutcomeFatal

3)

reactionmeddraversionpt18.1ReactionSocial avoidant behaviourOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb075945drugadministrationroute065drugindicationACNE

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application Number NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ... Brand Name ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ... Generic NameISOTRETINOINManufacturers Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ... product_ndc 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_id a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ... spl_set_id 3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ... Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2015M1028768

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use