PMID- 26719727
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20151231
LR  - 20201001
IS  - 1179-1365 (Print)
IS  - 1179-1365 (Electronic)
IS  - 1179-1365 (Linking)
VI  - 7
DP  - 2015
TI  - Safety profile of dalfampridine extended release in multiple sclerosis: 5-year 
      postmarketing experience in the United States.
PG  - 169-74
LID - 10.2147/DHPS.S97113 [doi]
AB  - BACKGROUND: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, 
      modified, or sustained-release fampridine outside the US), 10 mg twice daily, was 
      approved by the US Food and Drug Administration (FDA) in January 2010 to improve 
      walking in people with multiple sclerosis, as determined by an increase in 
      walking speed. OBJECTIVE: To provide a descriptive analysis of reported adverse 
      events (AEs) for commercially available dalfampridine-ER from March 2010 through 
      March 31, 2015. METHODS: Five-year postmarketing data for dalfampridine-ER were 
      available from the exposure of approximately 107,000 patients in the US (103,700 
      patient-years). Commonly reported AEs (>/=2% of all reported AEs) and serious AEs 
      were determined. The incidence of reported seizures was determined and the events 
      were further investigated. RESULTS: Among the 107,000 patients exposed to 
      dalfampridine-ER (70% female; mean age 52.1), the most common AEs were dizziness 
      (3.7%), insomnia (3.2%), balance disorder (3%), fall (2.4%), headache (2.4%), 
      nausea (2.1%), and urinary tract infection (2%). Other common AEs were drug 
      ineffectiveness (5.8%), gait disturbance (4.6%), and inappropriate dosing (3.1%). 
      Serious AEs included rare anaphylactic reactions (five cases) and drug 
      hypersensitivity reactions (eight cases). A total of 657 seizure cases were 
      reported (6.3/1,000 patient-years); of these, 324 were medically confirmed 
      (3.1/1,000 patient-years). Incidence of reported seizures was stable over time. 
      Duration of treatment prior to a seizure ranged from a single dose to >4 years; 
      12% of the seizures occurred within a week of starting treatment. CONCLUSION: The 
      5-year US postmarketing safety data of dalfampridine-ER is consistent with the 
      safety profile observed in clinical trials. Incidence of reported seizures 
      remained stable over time. Since commercial availability in March 2010, a warning 
      regarding the risk of anaphylaxis and severe allergic reactions was added to the 
      US prescribing information.
FAU - Jara, Michele
AU  - Jara M
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Aquilina, Thomas
AU  - Aquilina T
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Aupperle, Peter
AU  - Aupperle P
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
FAU - Rabinowicz, Adrian L
AU  - Rabinowicz AL
AD  - Acorda Therapeutics, Inc., Ardsley, NY, USA.
LA  - eng
PT  - Journal Article
DEP - 20151215
PL  - New Zealand
TA  - Drug Healthc Patient Saf
JT  - Drug, healthcare and patient safety
JID - 101544775
PMC - PMC4687626
OTO - NOTNLM
OT  - adverse events
OT  - dalfampridine
OT  - fampridine
OT  - multiple sclerosis
OT  - postmarketing safety
EDAT- 2016/01/01 06:00
MHDA- 2016/01/01 06:01
PMCR- 2015/12/15
CRDT- 2016/01/01 06:00
PHST- 2016/01/01 06:00 [entrez]
PHST- 2016/01/01 06:00 [pubmed]
PHST- 2016/01/01 06:01 [medline]
PHST- 2015/12/15 00:00 [pmc-release]
AID - dhps-7-169 [pii]
AID - 10.2147/DHPS.S97113 [doi]
PST - epublish
SO  - Drug Healthc Patient Saf. 2015 Dec 15;7:169-74. doi: 10.2147/DHPS.S97113. 
      eCollection 2015.