+ Site Statistics
References:
54,258,434
Abstracts:
29,560,870
PMIDs:
28,072,757
+ Search Articles
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ PDF Full Text
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Translate
+ Recently Requested

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



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



Drug, Healthcare and Patient Safety 7: 169-174



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. To provide a descriptive analysis of reported adverse events (AEs) for commercially available dalfampridine-ER from March 2010 through March 31, 2015. 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. 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. 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.

(PDF emailed within 0-6 h: $19.90)

Accession: 058803994

Download citation: RISBibTeXText

PMID: 26719727

DOI: 10.2147/DHPS.S97113


Related references

Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US. Neuropsychiatric Disease and Treatment 9: 365-370, 2013

The safety profile of dalfampridine extended release in multiple sclerosis clinical trials. Clinical Therapeutics 34(5): 1056-1069, 2012

Pharmacokinetic profile of dalfampridine extended release: clinical relevance in patients with multiple sclerosis. Current Medical Research and Opinion 29(12): 1627-1636, 2014

Dalfampridine extended release: in multiple sclerosis. Cns Drugs 24(10): 883-891, 2010

A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Annals of Neurology 68(4): 494-502, 2010

Evaluation of Dalfampridine Extended Release 5 and 10 mg in Multiple Sclerosis: A Randomized Controlled Trial. International Journal of Ms Care 17(3): 138-145, 2015

Impact of extended-release dalfampridine on walking ability in patients with multiple sclerosis. Neuropsychiatric Disease and Treatment 7: 229-239, 2011

Extended-release dalfampridine in the management of multiple-sclerosis-related walking impairment. Therapeutic Advances in Neurological Disorders 5(4): 199-204, 2012

A Randomized Crossover Trial of Dalfampridine Extended Release for Effect on Ambulatory Activity in People with Multiple Sclerosis. International Journal of Ms Care 18(4): 170-176, 2016

Prescriber utilization of dalfampridine extended release tablets in multiple sclerosis: a retrospective pharmacy and medical claims analysis. Therapeutics and Clinical Risk Management 11: 1-7, 2015

Treatment patterns and health care resource utilization associated with dalfampridine extended release in multiple sclerosis: a retrospective claims database analysis. Clinicoeconomics and Outcomes Research 8: 177-186, 2016

Effects of Dalfampridine Extended-release Tablets on 6-minute Walk Distance in Patients With Multiple Sclerosis: A Post Hoc Analysis of a Double-blind, Placebo-controlled Trial. Clinical Therapeutics 37(12): 2780-2787, 2016

Safety of EMBEda (morphine sulfate and naltrexone hydrochloride) extended-release capsules: review of postmarketing adverse events during the first year. Journal of Opioid Management 8(2): 115-125, 2012

Dalfampridine sustained-release for symptomatic improvement of walking speed in patients with multiple sclerosis. Core Evidence 5: 107-112, 2010

Safety profile of copolymer 1: Analysis of cumulative experience in the United States and Israel. Journal of Neurology 243(4 SUPPL. 1): S23-S26, 1996