Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10049763serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-SA-POMP-1003147occurcountryUSseriousnessother1duplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age17Unit of Onset AgeyearsWeight45SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionTetanyOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionMyopathyOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionMyositisOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionPainOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionMuscle atrophyOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb8.8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext8.8 MG/KG, QWdrugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat102drugstartdate31/12/2010actiondrug4

openFDA Info on Medication

Application NumberBLA125291Brand NameLUMIZYMEGeneric NameALGLUCOSIDASE ALFAManufacturersGenzyme Corporationproduct_ndc58468-0160Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsALGLUCOSIDASE ALFARXCUI629568, 993072spl_id8884fa90-01b8-49b5-836c-303db62c7c6bspl_set_idd6bfbc45-2d34-439e-8aad-59ee2d53d4dfPackage NDC58468-0160-1, 58468-0160-2NUIM0000794, N0000175821Chemical Structurealpha-Glucosidases [CS]Established Pharmacologic ClassHydrolytic Lysosomal Glycogen-specific Enzyme [EPC]UNIIDTI67O9503

2)

drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat610drugstartdate/01/2013actiondrug4

openFDA Info on Medication

Application NumberBLA125291Brand NameLUMIZYMEGeneric NameALGLUCOSIDASE ALFAManufacturersGenzyme Corporationproduct_ndc58468-0160Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsALGLUCOSIDASE ALFARXCUI629568, 993072spl_id8884fa90-01b8-49b5-836c-303db62c7c6bspl_set_idd6bfbc45-2d34-439e-8aad-59ee2d53d4dfPackage NDC58468-0160-1, 58468-0160-2NUIM0000794, N0000175821Chemical Structurealpha-Glucosidases [CS]Established Pharmacologic ClassHydrolytic Lysosomal Glycogen-specific Enzyme [EPC]UNIIDTI67O9503

3)

drugcharacterization2medicinalproductDIPHENHYDRAMINEdrugdosagetextUNKdrugindicationPREMEDICATION

openFDA Info on Medication

Application Numberpart341, ANDA205723, ANDA040466Brand NameNIGHTIME SLEEP AID, DIPHENHYDRAMINEGeneric NameDIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HCLManufacturers Velocity Pharma, AAA Pharmaceutical, Inc., Safetec of America, Inc., Micro Labs ... product_ndc76168-065, 57344-090, 61010-4409, 42571-169, 42571-337, 68196-929, 63323-664Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1020477, 1049630, 1049909, 1723740spl_id 6cbc010f-0449-cb45-e053-2a91aa0a1ec6, 94e265d8-7fba-2ee9-e053-2a95a90a4993, 8909 ... spl_set_id 9c44e54f-d8bc-4451-8382-40d2e8e03b42, 76724432-ff3c-404f-ba1f-5af68e3ab8c4, ef6b ... Package NDC 76168-065-37, 57344-090-02, 57344-090-03, 61010-4409-0, 61010-4409-1, 61010-4409 ... UNIITC2D6JAD40

4)

drugcharacterization2medicinalproductIBUPROFENdrugdosagetextUNKdrugindicationPREMEDICATION

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

5)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

6)

drugcharacterization2medicinalproductAMITRIPTYLINE HYDROCHLORIDEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QD

openFDA Info on Medication

Application Number ANDA085969, ANDA085966, ANDA085968, ANDA085971, ANDA085967, ANDA085970, ANDA2024 ... Brand NameAMITRIPTYLINE HYDROCHLORIDEGeneric NameAMITRIPTYLINE HYDROCHLORIDEManufacturers Northstar RxLLC, Accord Healthcare Inc., Mylan Pharmaceuticals Inc., Sandoz Inc, ... product_ndc 16714-446, 16714-447, 16714-448, 16714-449, 16714-450, 16714-451, 16729-171, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMITRIPTYLINE HYDROCHLORIDERXCUI856762, 856773, 856783, 856834, 856845, 856853spl_id 2cd883f4-4d52-43f6-82be-a78c417f3578, 958ff135-0d53-c264-e053-2a95a90a8c92, 2534 ... spl_set_id 23521590-ec42-4845-aab4-600f6b79e084, 1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd, 61d2 ... Package NDC 16714-446-01, 16714-446-02, 16714-447-01, 16714-447-02, 16714-448-01, 16714-448- ... UNII26LUD4JO9K

7)

drugcharacterization2medicinalproductEPHEDRINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, BIDdrugadministrationroute048

8)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, TIDdrugdosageformCAPSULEdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

9)

drugcharacterization2medicinalproductCELECOXIBdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, BIDdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA206827, ANDA202240, ANDA210071, ANDA213598, ANDA078857, ANDA207061, ANDA2074 ... Brand NameCELECOXIB, GENERIC DRUG, CELEBREX, ELYXYBGeneric NameCELECOXIBManufacturers Aurobindo Pharma Limited, Lupin Pharmaceuticals, Inc., Westminster Pharmaceutica ... product_ndc 65862-907, 65862-908, 65862-909, 65862-910, 68180-395, 68180-396, 68180-397, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 349514, 686379, 213468, 213469, 352314, 686381, 2373454, 2373460spl_id 2c7a25a6-20f1-4f77-b50b-69f7cbf7a61a, 333b6f4b-c4ec-4a14-bb70-bc255cedefa5, 43a1 ... spl_set_id 1e811c3a-5653-4617-b958-380802cc443a, 560017b1-daf8-464e-b86f-0a75c78002ec, cb0b ... Package NDC 65862-907-60, 65862-907-99, 65862-908-01, 65862-908-05, 65862-908-99, 65862-909- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

10)

drugcharacterization2medicinalproductPARACETAMOLdrugdosagetextUNKdrugdosageformCAPSULE

11)

drugcharacterization2medicinalproductPREDNISONEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG (3 TABLETS), QDdrugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

12)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG (1 TABLET), QD (EVERY MORNING)drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-POMP-1003147

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use