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Original Research

Safety profile of dalfampridine extended release in multiple sclerosis: 5-year postmarketing experience in the United States

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Pages 169-174 | Published online: 15 Dec 2015

References

  • LaRoccaNGImpact of walking impairment in multiple sclerosis: perspectives of patients and care partnersPatient20114318920121766914
  • GoodmanADBrownTRKruppLBSustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trialLancet2009373966573273819249634
  • GoodmanADBrownTREdwardsKRA phase 3 trial of extended release oral dalfampridine in multiple sclerosisAnn Neurol201068449450220976768
  • Ampyra® (dalfampridine) extended release (ER) tablets [prescribing information]New YorkAcorda Therapeutics, Inc.2014
  • DunnJBlightADalfampridine: a brief review of its mechanism of action and efficacy as a treatment to improve walking in patients with multiple sclerosisCurr Med Res Opin20112771415142321595605
  • NicolettiASofiaVBiondiREpilepsy and multiple sclerosis in Sicily: a population-based studyEpilepsia200344111445144814636354
  • PoserCMBrinarVVEpilepsy and multiple sclerosisEpilepsy Behav20034161212609222
  • HautSRBienenEJMillerAClinical overview of the seizure risk of dalfampridineExpert Opin Drug Saf201211465165722703551
  • CornblathDRBienenEJBlightARThe safety profile of dalfampridine extended release in multiple sclerosis clinical trialsClin Ther20123451056106922497693
  • GoodmanADBethouxFBrownTRLong-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: results of open-label extensions of two Phase 3 clinical trialsMult Scler201521101322133125583832
  • ErikssonMBen-MenachemEAndersenOEpileptic seizures, cranial neuralgias and paroxysmal symptoms in remitting and progressive multiple sclerosisMult Scler20028649549912474990
  • Food and Drug AdministrationSupplemental Approval, Release REMS Requirement, REMS Assessment AcknowledgmentSilver Spring, MDFood and Drug Administration2013 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s008ltr.pdfAccessed November 4, 2015
  • JaraMBarkerGHenneyHR3rdDalfampridine extended-release tablets: one year of post-marketing safety experience in the United StatesNeuropsychiatr Dis Treat2013936537023662056
  • US Food and Drug Administration [homepage on the Internet]FDA Adverse Event Reporting System (FAERS) Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/Accessed November 4, 2015
  • JaraMAderaMAdedejiAHenneyHCarrazanaEDalfampridine Extended Release Tablets: Safety Profile After 2 Years of Post-marketing Experience in the United States [abstract]Mult Scler
  • BertheCOngagnaJCCourtoisSProlonged-release Fampridine post-marketing experience in Alsace, France [abstract]Neurology201584SupplP1.126
  • JaraMSidovarMFHenneyHR3rdPrescriber utilization of dalfampridine extended release tablets in multiple sclerosis: a retrospective pharmacy and medical claims analysisTher Clin Risk Manag2014111725565851
  • KantorDChancellorMBSnellCWHenneyHR3rdRabinowiczALAssessment of confirmed urinary tract infection in patients treated with dalfampridine for multiple sclerosisPostgrad Med2015127221822225560174
  • HuppertsRLyckeJShortCProlonged-release fampridine and walking and balance in multiple sclerosis: randomized MOBILE studyMult Scler Epub2015428
  • MatsudaPNShumway-CookABamerAMJohnsonSLAmtmannDKraftGHFalls in multiple sclerosisPM R20113762463221777861
  • GunnHJNewellPHaasBMarsdenJFFreemanJAIdentification of risk factors for falls in multiple sclerosis: a systematic review and meta-analysisPhys Ther201393450451323237970
  • NilsagardYGunnHFreemanJFalls in people with MS-an individual data meta-analysis from studies from Australia, Sweden, United Kingdom and the United StatesMult Scler20152119210024948687
  • HowardRSWilesCMHirschNPLohLSpencerGTNewsom-DavisJRespiratory involvement in multiple sclerosisBrain1992115Pt 24794941606478
  • van KlaverenRBuyseTVan De GaerLMeekersJRochetteFDemedtsMMicturitional disturbances are associated with impaired breathing control in multiple sclerosisChest199911561539154510378546
  • FarhatMRLoringSHRiskindPWeinhouseGDisturbance of respiratory muscle control in a patient with early-stage multiple sclerosisEur Respir J20134161454145623728406
  • MarrieRAReiderNCohenJA systematic review of the incidence and prevalence of cardiac, cerebrovascular, and peripheral vascular disease in multiple sclerosisMult Scler201521331833125533300
  • MarrieRARudickRHorwitzRVascular comorbidity is associated with more rapid disability progression in multiple sclerosisNeurology201074131041104720350978
  • SiegertRJAbernethyDADepression in multiple sclerosis: a reviewJ Neurol Neurosurg Psychiatry200576446947515774430
  • ManouchehriniaATanasescuRTenchCRConstantinescuCSMortality in multiple sclerosis: meta-analysis of standardised mortality ratiosJ Neurol Neurosurg Psychiatry Epub201552
  • WoodRACamargoCAJrLiebermanPAnaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United StatesJ Allergy Clin Immunol2014133246146724144575
  • Food and Drug AdministrationNDA ApprovalSilver Spring, MDFood and Drug Administration2010 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022250s000ltr.pdfAccessed November 4, 2015
  • JaraMGauvinDVCaggianoAOWalterBParryTJHenneyHEvaluation of the Abuse Potential of Dalfampridine Extended Release Tablets (P565)28th Congress of the European Committee for Treatment and Research in Multiple SclerosisOctober 10–13; 2012Lyon, France