Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI036913occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10128370Date Received28/04/2014transmissiondate12/12/2014serious2Date Last Updated28/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age63Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionPainOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTECFIDERAdrugauthorizationnumb204063drugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISactiondrug4

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)

drugcharacterization2medicinalproductBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

3)

drugcharacterization2medicinalproductBUTALBITAL-APAP-CAFF-COD

4)

drugcharacterization2medicinalproductGABAPENTIN

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

5)

drugcharacterization2medicinalproductIMIPRAMINE HCL

6)

drugcharacterization2medicinalproductLEVOTHROID

7)

drugcharacterization2medicinalproductNAPROXEN COMFORT PAC

8)

drugcharacterization2medicinalproductPRAVASTATIN SODIUM

openFDA Info on Medication

Application Number ANDA209869, ANDA207068, ANDA076056, ANDA077793, ANDA076714, ANDA077917, ANDA2033 ... Brand NamePRAVASTATIN SODIUM, PRAVACHOLGeneric NamePRAVASTATIN SODIUMManufacturers BIOCON PHARMA INC.,, Accord Healthcare Inc., Teva Pharmaceuticals USA, Inc., Dr. ... product_ndc 70377-045, 70377-046, 70377-047, 70377-048, 16729-008, 16729-009, 16729-010, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAVASTATIN SODIUMRXCUI904458, 904467, 904475, 904481, 904469, 904477spl_id 35751ea8-7d0f-5334-0e36-df438b2b9202, 96d49c2d-3263-3692-e053-2995a90ac8f4, c288 ... spl_set_id 9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb, 6c011348-a236-47d3-bbef-3e0b956dd080, 99e0 ... Package NDC 70377-045-11, 70377-045-12, 70377-045-14, 70377-046-11, 70377-046-12, 70377-046- ... UNII3M8608UQ61

9)

drugcharacterization2medicinalproductPREDNISONE PAK

10)

drugcharacterization2medicinalproductRANITIDINE HCL

11)

drugcharacterization2medicinalproductSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application Number ANDA076847, NDA020080, ANDA078593, ANDA090495, NDA208223, ANDA077744, ANDA078327 ... Brand NameSUMATRIPTAN SUCCINATE, ZEMBRACE SYMTOUCH, SUMATRIPTAN, ONZETRA, ONZETRA XSAILGeneric NameSUMATRIPTAN SUCCINATEManufacturers Dr. Reddy's Laboratories Limited, Sandoz Inc, Wockhardt USA LLC., Prasco Laborat ... product_ndc 55111-291, 55111-292, 55111-293, 0781-3169, 0781-3173, 0781-3174, 0781-3170, 078 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUS, NASALActive IngredientsSUMATRIPTAN SUCCINATERXCUI 313160, 313161, 315223, 313165, 1657160, 1657173, 1793916, 1657151, 1738576, 173 ... spl_id 8c734b50-3369-df0f-8a18-5bd1bdf51093, 11978034-eb0c-4d7f-ab70-4375b71c1684, 8fed ... spl_set_id ac80d018-6abf-2e41-ddea-90b4ff9e9013, e6058c90-eae2-4207-ba7d-563fe4a51112, e091 ... Package NDC 55111-291-30, 55111-291-36, 55111-291-90, 55111-291-01, 55111-291-05, 55111-291- ... UNIIJ8BDZ68989

12)

drugcharacterization2medicinalproductTOPIRAMATE

openFDA Info on Medication

Application Number ANDA079162, ANDA078235, NDA020505, NDA020844, NDA205122, ANDA078877, ANDA207382, ... Brand NameTOPIRAMATE, TOPAMAX, QUDEXY XR, TROKENDI XRGeneric NameTOPIRAMATEManufacturers Golden State Medical Supply, Inc., Cadila Healthcare Limited, Cipla USA Inc., Zy ... product_ndc 60429-769, 60429-770, 60429-771, 60429-772, 65841-647, 65841-648, 65841-649, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 199888, 199889, 199890, 151227, 151228, 151229, 152855, 205315, 205316, ... spl_id 7b3298bf-7f7e-d7d0-e053-2a91aa0ab74b, ecd79705-832b-42c4-be26-82d93432cf7c, 6885 ... spl_set_id 5c44de38-a291-471d-8335-abc65e04387d, 57016639-89fe-43ad-89c4-5e7a756dddec, 4087 ... Package NDC 60429-769-60, 60429-769-05, 60429-769-10, 60429-770-60, 60429-770-05, 60429-770- ... 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

13)

drugcharacterization2medicinalproductZOLOFT

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

14)

drugcharacterization2medicinalproductASPIRIN

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

15)

drugcharacterization2medicinalproductCALCIUM + VITAMIN D3

16)

drugcharacterization2medicinalproductFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

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duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI036913