PMID- 23662056
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130513
LR  - 20211021
IS  - 1176-6328 (Print)
IS  - 1178-2021 (Electronic)
IS  - 1176-6328 (Linking)
VI  - 9
DP  - 2013
TI  - Dalfampridine extended release tablets: 1 year of postmarketing safety experience 
      in the US.
PG  - 365-70
LID - 10.2147/NDT.S41596 [doi]
AB  - BACKGROUND: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, 
      modified, or sustained-release fampridine in some countries) were approved in the 
      US to improve walking in patients with multiple sclerosis, as demonstrated by 
      improvement in walking speed. Postmarketing safety experience is available from 
      exposure of approximately 46,000 patients in the US from product approval through 
      March 2011. OBJECTIVE: To provide a descriptive analysis of all spontaneously 
      reported postmarketing adverse events (AEs) for dalfampridine-ER since product 
      launch. METHODS: AE data were extracted from the safety database from product 
      launch through March 31, 2011; AEs were classified using the Medical Dictionary 
      for Regulatory Activities. Seizure cases were reviewed for patient demographics, 
      time to event from treatment onset, and presence of additional risk factors. 
      RESULTS: THE MOST FREQUENTLY REPORTED POSTMARKETING AES WERE SIMILAR TO THOSE 
      REPORTED DURING CLINICAL DEVELOPMENT: dizziness, insomnia, balance disorder, 
      headache, nausea, urinary tract infection, asthenia, and back pain (all included 
      in US product labeling). New clinically significant findings are related to lack 
      of efficacy and inappropriate dosing. Of the approximately 46,000 patients 
      exposed, 85 seizures were reported ( approximately 5.4/1000 patient-years), of which 82 were 
      reported or confirmed by a health care practitioner ( approximately 5.2/1000 patient-years). 
      Beyond the intrinsic multiple sclerosis-related seizure risk, more than half of 
      the 85 cases (62%) had an additional potential risk factor for seizure including 
      a previous history of convulsions, renal impairment, incorrect dosing, or use of 
      concurrent medications with a labeled seizure risk. Duration of treatment prior 
      to the seizure ranged from one dose to 365 days; 26/85 (31%) patients suffered a 
      seizure within a week of starting treatment. CONCLUSION: Spontaneous safety data 
      from the US postmarketing experience were consistent with the safety profile seen 
      during clinical development. Although first-year seizure incidence was not 
      substantially different from that observed in dalfampridine-ER clinical trials, 
      patients should be monitored for concomitant use of drugs that lower seizure 
      threshold.
FAU - Jara, Michele
AU  - Jara M
AD  - Acorda Therapeutics, Inc, Ardsley, NY, USA;
FAU - Barker, Graham
AU  - Barker G
FAU - Henney, Herbert R 3rd
AU  - Henney HR 3rd
LA  - eng
PT  - Journal Article
DEP - 20130310
PL  - New Zealand
TA  - Neuropsychiatr Dis Treat
JT  - Neuropsychiatric disease and treatment
JID - 101240304
PMC - PMC3647381
OTO - NOTNLM
OT  - adverse events
OT  - dalfampridine
OT  - fampridine
OT  - multiple sclerosis
OT  - postmarketing safety
OT  - seizure
EDAT- 2013/05/11 06:00
MHDA- 2013/05/11 06:01
PMCR- 2013/03/10
CRDT- 2013/05/11 06:00
PHST- 2013/03/09 00:00 [received]
PHST- 2013/05/11 06:00 [entrez]
PHST- 2013/05/11 06:00 [pubmed]
PHST- 2013/05/11 06:01 [medline]
PHST- 2013/03/10 00:00 [pmc-release]
AID - ndt-9-365 [pii]
AID - 10.2147/NDT.S41596 [doi]
PST - ppublish
SO  - Neuropsychiatr Dis Treat. 2013;9:365-70. doi: 10.2147/NDT.S41596. Epub 2013 Mar 
      10.