Adverse Event Report

Report

Safety Report ID6408854-4transmissiondateformat102transmissiondate25/05/2010serious1seriousnessother1receivedateformat102Date Received21/10/2009receiptdateformat102Date Last Updated06/10/2009fulfillexpeditecriteria1companynumb980108-107050098

Primary Source

reportercountryUNITED STATESqualification1

Sender

senderorganizationFDA-Public UseReceiver-

Patient

Onset Age88Unit of Onset AgeyearsSexFemale

Reaction

1)

ReactionELECTROCARDIOGRAM QT PROLONGED

2)

ReactionTORSADE DE POINTES

Drug

1)

drugcharacterization1medicinalproductLEVAQUINdrugauthorizationnumb020635drugadministrationroute041drugindicationBRONCHITISdrugtreatmentduration5drugtreatmentdurationunit804

2)

drugcharacterization2medicinalproductPROCAINAMIDE HCLdrugadministrationroute041drugindicationATRIAL FIBRILLATION

3)

drugcharacterization2medicinalproductALBUTEROLdrugadministrationroute055drugindicationBRONCHITIS

openFDA Info on Medication

Application Number ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ... Brand NameALBUTEROLGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ... product_ndc 75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318spl_id 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ... Package NDC 75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ... UNII021SEF3731

4)

drugcharacterization2medicinalproductCORTICOSTEROIDSdrugindicationDRUG USE FOR UNKNOWN INDICATION

5)

drugcharacterization2medicinalproductFUROSEMIDEdrugadministrationroute065drugindicationDRUG USE FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5