Post-marketing safety surveillance of dalfampridine for multiple sclerosis using FDA adverse event reporting system

Frontiers in Pharmacology, 2023 · DOI: 10.3389/fphar.2023.1226086 · Published: September 14, 2023

Simple Explanation

This study investigates the safety of dalfampridine, a drug used to improve walking in multiple sclerosis (MS) patients, by analyzing adverse event (AE) reports submitted to the FDA. The researchers used data from the FDA Adverse Event Reporting System (FAERS) to identify and analyze AE signals associated with dalfampridine. The study found several known and new AE signals, providing a reference for the safe use of dalfampridine in treating MS.

Study Duration

February 2010 to September 2022

Participants

44,092 dalfampridine-related AE reports

Evidence Level

Not specified

Key Findings

1
The study identified 335 AE signals related to dalfampridine, with a higher occurrence in females and individuals aged 45–65, aligning with MS epidemiology.
2
Several AE signals, including spinal cord injury cauda equina, haemoglobin urine present, and abnormal urine tests, were not previously described in the drug's instructions.
3
Urinary tract infection, dizziness, and condition aggravated were the most frequently reported AE signals.

Research Summary

This study analyzed adverse event (AE) reports of dalfampridine from the FDA Adverse Event Reporting System (FAERS) to investigate its post-marketing safety. The analysis identified 335 AE signals, with the most common being urinary tract infection, dizziness, and condition aggravated. Some signals, like spinal cord injury cauda equina, were not previously listed in the drug's information. The study highlights the importance of post-marketing surveillance for identifying potential adverse effects and provides a reference for the safe use of dalfampridine in treating multiple sclerosis.

Practical Implications

Enhanced Monitoring

Clinicians should closely monitor patients on dalfampridine, especially for urinary tract infections, dizziness, and any signs of spinal cord issues.

Informed Prescribing

Prescribers should be aware of the potential for previously undocumented adverse events, such as spinal cord injury cauda equina, and consider these risks when prescribing dalfampridine.

Patient Education

Patients should be educated about the common and potential rare adverse effects of dalfampridine, encouraging them to report any new or worsening symptoms promptly.

Study Limitations

1
Reliance on FAERS data, which may contain unreported or incomplete information.
2
The FAERS database primarily contains data from the United States, limiting the generalizability of findings to other ethnic groups.
3
The study is descriptive and cannot establish a causal relationship between dalfampridine and the identified adverse events.

Your Feedback

Was this summary helpful?

Back to Pharmacology