Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10049841serious1Date Last Updated01/04/2014receiptdateformat102companynumbUS-SA-POMP-1002359occurcountryUSduplicate1Date Received01/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age16Unit of Onset AgeyearsWeight50.6SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionMusculoskeletal chest painOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionBlood creatine phosphokinase increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbE1074C01drugauthorizationnumb125291drugstructuredosagenumb17.8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext17.8 MG/KG, Q2WdrugdosageformPOWDER 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)

drugcharacterization1medicinalproductLUMIZYMEdrugbatchnumbUNKNOWNdrugauthorizationnumb125291drugstructuredosagenumb19.8drugstructuredosageunit007drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext19.8 MG/KG, Q2WdrugdosageformPOWDER FOR SOLUTION FOR INFUSIONdrugadministrationroute042drugindicationGLYCOGEN STORAGE DISEASE TYPE IIdrugstartdateformat602drugstartdate//2012actiondrug4

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)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugadministrationroute065

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductAMITRIPTYLINE HYDROCHLORIDEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugadministrationroute065

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., Lifestar Ph ... 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

5)

drugcharacterization2medicinalproductEPHEDRINEdrugdosagetextUNKdrugadministrationroute065

6)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, TIDdrugadministrationroute065

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

7)

drugcharacterization2medicinalproductCELECOXIBdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, BIDdrugadministrationroute065

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

8)

drugcharacterization2medicinalproductDIPHENHYDRAMINE HYDROCHLORIDEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute048drugindicationPREMEDICATION

openFDA Info on Medication

Application Number part338, part341, part348, ANDA087513, ANDA040498, part336, ANDA080817, ANDA2057 ... Brand Name UP AND UP NIGHTTIME SLEEP AID, DIPHENHYDRAMINE HYDROCHLORIDE, BENADRYL ULTRA TAB ... Generic NameDIPHENHYDRAMINE HYDROCHLORIDEManufacturers Target Corporation, Epic Pharma, LLC, JC World Bell Wholesale Co., Inc., Aurohea ... product_ndc 11673-186, 42806-649, 50269-226, 58602-024, 59726-404, 68210-1280, 41250-379, 53 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, TOPICALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI 1248354, 1020477, 1049630, 1049632, 1049909, 1049906, 1789740, 1092466, 1248356, ... spl_id 5f5e1563-73fa-4066-9c7f-9fa04aca648f, 4884641f-c4af-4148-89c1-0e29c6ec6e5e, 746d ... spl_set_id 0ab5a374-d565-4385-bee3-538a8f09b19e, 15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c, 1763 ... Package NDC 11673-186-40, 42806-649-10, 50269-226-54, 58602-024-16, 58602-024-31, 58602-024- ... UNIITC2D6JAD40, NBZ3QY004S, 362O9ITL9D

9)

drugcharacterization2medicinalproductMETHYLPREDNISOLONE SODIUM SUCCINATEdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKdrugadministrationroute042drugindicationPREMEDICATION

openFDA Info on Medication

Application NumberANDA040583, ANDA040612, NDA011856, ANDA207667, ANDA207549, ANDA202691Brand NameMETHYLPREDNISOLONE SODIUM SUCCINATE, SOLU-MEDROLGeneric NameMETHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONEManufacturers Fresenius Kabi USA, LLC, Pharmacia and Upjohn Company LLC, AuroMedics Pharma LLC ... product_ndc 63323-255, 63323-265, 63323-258, 0009-0003, 0009-0758, 0009-0698, 0009-0796, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE SODIUM SUCCINATERXCUI 311659, 314099, 1743704, 207191, 207193, 1357886, 1357888, 1743707, 1743720, 174 ... spl_id 9b01b051-abec-2e70-e053-2a95a90aaf1e, 8859cd6d-d589-4d14-9585-4ae8b7de8329, fe63 ... spl_set_id c5d22210-73c6-4697-a267-75e243508642, cd99be87-c8d9-48d6-a8e5-e081052e3f19, 2035 ... Package NDC 63323-265-30, 63323-255-03, 63323-258-03, 0009-0758-01, 0009-0698-01, 0009-0796- ... UNIILEC9GKY20K

10)

drugcharacterization2medicinalproductIBUPROFENdrugstructuredosagenumb400drugstructuredosageunit003drugdosagetext400 MG, UNKdrugadministrationroute048drugindicationPREMEDICATION

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

Report Duplicate

duplicatesourceAVENTISduplicatenumbUS-SA-POMP-1002359

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use