Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10332209primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate20/07/2015reporttype1serious2receivedateformat102Date Received22/07/2014receiptdateformat102Date Last Updated19/01/2015fulfillexpeditecriteria2companynumbUS-UNITED THERAPEUTICS-UNT-2014-000542duplicate1

Report Duplicate

duplicatesourceUNITED THERAPEUTICSduplicatenumbUS-UNITED THERAPEUTICS-UNT-2014-000542

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age62Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionBack painOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionSwellingOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionFluid retentionOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductFERROUS SULFATEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFERROUS SULFATE\FERROUS SULFATE, DRIED

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATEManufacturersRichmond Pharmaceuticals, Inc., Boiron, Richmond Pharmaceuticals Inc.product_ndc54738-963, 0220-2111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 9a63 ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 5514 ... Package NDC54738-963-01, 54738-963-03, 0220-2111-41, 54738-963-13UNII39R4TAN1VT

2)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

3)

drugcharacterization1medicinalproductREMODULINdrugauthorizationnumb021272drugdosagetext0.055-0.066 ?G/KG/MIN, CONTINUINGdrugdosageformINJECTIONdrugadministrationroute041drugindicationPULMONARY ARTERIAL HYPERTENSIONdrugstartdateformat102drugstartdate22/03/2014actiondrug4

activesubstance

activesubstancenameTREPROSTINIL

openFDA Info on Medication

Application NumberNDA021272Brand NameREMODULINGeneric NameTREPROSTINILManufacturersUnited Therapeutics Corporationproduct_ndc66302-101, 66302-102, 66302-105, 66302-110, 66302-120, 66302-150Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsTREPROSTINILRXCUI349407, 349408, 349409, 349410, 352211, 352212, 352213, 352214, 2590175, 2590177spl_idaeaf7f59-419a-4571-9839-7a1c576b1e73spl_set_id6c80bb38-e8db-4138-9f0d-dbbf9c673185Package NDC 66302-101-01, 66302-102-01, 66302-105-01, 66302-110-01, 66302-120-01, 66302-150- ... NUIN0000175416, M0017817, N0000009909Established Pharmacologic ClassProstacycline Vasodilator [EPC]Chemical StructureProstaglandins I [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNII059QF0KO0R, RUM6K67ESG

4)

drugcharacterization1medicinalproductOPSUMITdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate05/05/2014drugenddateformat102drugenddate20/05/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameMACITENTAN

openFDA Info on Medication

Application NumberNDA204410Brand NameOPSUMITGeneric NameMACITENTANManufacturersActelion Pharmaceuticals US, Inc.product_ndc66215-501Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMACITENTANRXCUI1442137, 1442143spl_id7e422256-207c-4f3b-b5e0-8e94c33b1eccspl_set_id1e484a50-55db-4b85-8c57-6cd1b0353abdPackage NDC66215-501-30, 66215-501-15NUIN0000175581, N0000175364Established Pharmacologic ClassEndothelin Receptor Antagonist [EPC]Mechanism of ActionEndothelin Receptor Antagonists [MoA]UNIIZ9K9Y9WMVL

5)

drugcharacterization2medicinalproductLASIXdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

summary

narrativeincludeclinicalCASE EVENT DATE: 20140505