Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI029647occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10057776Date Received04/04/2014transmissiondate12/12/2014serious2Date Last Updated04/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age21Unit of Onset AgeyearsWeight78SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionBalance disorderOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionConfusional stateOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionTremorOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionMultiple sclerosis relapseOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductTECFIDERAdrugauthorizationnumb204063drugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationRELAPSING-REMITTING MULTIPLE SCLEROSISdrugstartdateformat610drugstartdate/06/2013drugenddateformat102drugenddate13/12/2013actiondrug1

openFDA Info on Medication

Application NumberNDA204063Brand NameTECFIDERAGeneric NameDIMETHYL FUMARATEManufacturersBiogen Inc.product_ndc64406-005, 64406-007, 64406-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIMETHYL FUMARATERXCUI1373483, 1373489, 1373491, 1373493, 1373497, 1373498spl_id9b17ffc0-f173-4a40-af22-80f21d069ebaspl_set_id665d7e74-036c-5f68-5b67-ab84b9b49151Package NDC64406-007-03, 64406-005-01, 64406-006-02UNIIFO2303MNI2

2)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLET

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

3)

drugcharacterization2medicinalproductTYLENOLdrugindicationHEADACHE

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id bf686cc3-17be-4bb9-bd87-f8f50b65d874, 068c419e-d1f7-46d9-bdd0-05aa4039a374, c138 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

4)

drugcharacterization2medicinalproductTOPAMAXdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804

openFDA Info on Medication

Application NumberNDA020505, NDA020844Brand NameTOPAMAXGeneric NameTOPIRAMATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-639, 50458-640, 50458-641, 50458-642, 50458-647, 50458-645Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, ... spl_id97a88b90-639a-11ea-a5cc-2737fc2ca371spl_set_id21628112-0c47-11df-95b3-498d55d89593Package NDC 50458-639-65, 50458-640-65, 50458-641-65, 50458-642-65, 50458-647-65, 50458-645- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

5)

drugcharacterization2medicinalproductSUMATRIPTAN

openFDA Info on Medication

Application Number ANDA090314, NDA020626, NDA020080, ANDA200183, ANDA213465, ANDA202758, NDA020132, ... Brand NameSUMATRIPTAN, IMITREX, ZEMBRACE SYMTOUCH, TOSYMRAGeneric NameSUMATRIPTAN, SUMATRIPTAN SUCCINATEManufacturers Mylan Institutional LLC, Sandoz Inc, GlaxoSmithKline LLC, West-Ward Pharmaceutic ... product_ndc 67457-879, 0781-6523, 0781-6524, 0173-0449, 0173-0739, 0173-0479, 0173-0478, 014 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, NASAL, ORALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 727339, 313159, 314227, 208452, 313165, 758523, 860088, 1657160, 1657173, 208450 ... spl_id 6b35dcf4-1400-48b7-bf5e-f98d6fbe41f7, c27e4143-221d-4c6b-aa68-feed80dc2285, 09b5 ... spl_set_id e08cfe65-a1ca-4526-ba1c-f6efe422785d, 6c95caa4-812e-4e47-bcfc-c641c00db3f7, fee7 ... Package NDC 67457-879-00, 67457-879-05, 0781-6524-06, 0781-6524-86, 0781-6523-06, 0781-6523- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

6)

drugcharacterization2medicinalproductSERTRALINE

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

7)

drugcharacterization2medicinalproductMETHYLPREDNISOLONEdrugadministrationroute042drugstartdateformat610drugstartdate/07/2013

openFDA Info on Medication

Application Number ANDA040232, ANDA210985, NDA011153, ANDA209097, ANDA040189, ANDA040194, ANDA20407 ... Brand NameMETHYLPREDNISOLONE, MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATEGeneric NameMETHYLPREDNISOLONEManufacturers Actavis Pharma, Inc., Ingenus Pharmaceuticals, LLC, Pharmacia and Upjohn Company ... product_ndc 0591-0790, 50742-189, 0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATERXCUI 259966, 762675, 197969, 197971, 197973, 207136, 207137, 207138, 207141, 260330, ... spl_id 042a4f34-c640-483d-b255-0b8f9918fc72, 27eb4db1-87bf-4af7-a238-f24c0e43d5fb, 8f9c ... spl_set_id a3c3048f-81a7-4a86-8a06-f1f00909f6d1, 0493f2e1-749f-43fe-b5f6-21baebd15c36, 39d5 ... Package NDC 0591-0790-01, 0591-0790-21, 50742-189-01, 50742-189-21, 0009-0049-02, 0009-0056- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023, LEC9GKY20K

8)

drugcharacterization2medicinalproductMETHYLPREDNISOLONEdrugadministrationroute042drugstartdateformat610drugstartdate/08/2013

openFDA Info on Medication

Application Number ANDA040232, ANDA210985, NDA011153, ANDA209097, ANDA040189, ANDA040194, ANDA20407 ... Brand NameMETHYLPREDNISOLONE, MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATEGeneric NameMETHYLPREDNISOLONEManufacturers Actavis Pharma, Inc., Ingenus Pharmaceuticals, LLC, Pharmacia and Upjohn Company ... product_ndc 0591-0790, 50742-189, 0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATERXCUI 259966, 762675, 197969, 197971, 197973, 207136, 207137, 207138, 207141, 260330, ... spl_id 042a4f34-c640-483d-b255-0b8f9918fc72, 27eb4db1-87bf-4af7-a238-f24c0e43d5fb, 8f9c ... spl_set_id a3c3048f-81a7-4a86-8a06-f1f00909f6d1, 0493f2e1-749f-43fe-b5f6-21baebd15c36, 39d5 ... Package NDC 0591-0790-01, 0591-0790-21, 50742-189-01, 50742-189-21, 0009-0049-02, 0009-0056- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023, LEC9GKY20K

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI029647