Movement disorders associated with antiseizure medications: A real-world disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System

Br J Clin Pharmacol. 2023 Nov;89(11):3389-3400. doi: 10.1111/bcp.15836. Epub 2023 Jul 18.

Abstract

Aims: Patients with epilepsy often require long-term use of antiseizure medications (ASMs) to control their seizures. However, movement disorders (MDs) related to ASMs can significantly impact their quality of life. This study aims to analyse MDs related to ASMs in the Food and Drug Administration Adverse Event Reporting System database to provide recommendations for safe medication.

Methods: All adverse drug reactions associated with 26 marketed ASMs in Food and Drug Administration Adverse Event Reporting System were extracted for analysis. Disproportionality analyses were used to assess the association between ASMs and MDs, and signal colour scale maps were created to identify potential ASM-MD safety signals.

Results: A total of 1921 cases experienced MDs while taking ASMs were included. A higher prevalence of MDs was observed in females compared to males. The association between specific MDs with ASMs was revealed, including known and unknown MDs such as tremors, Parkinson and paralysis. Lamotrigine and carbamazepine exhibited multiple significant MDs, while levetiracetam and pregabalin were linked to the earlier onset of MDs. Generally, higher doses were linked to a higher incidence of MDs.

Conclusion: MDs were the most obvious adverse drug reactions in the nervous system triggered by using ASMs. Fourteen drugs exhibited positive signals for MDs, including some not previously reported. Conversely, 12 ASMs were deemed to have a lower possibility of inducing MDs. The incidence of MDs can be mitigated by selecting appropriate ASMs for epileptic patients. These findings enhance our understanding of the relationship between ASMs and MDs.

Keywords: FAERS database; antiseizure medications; drug safety; movement disorders; pharmacovigilance.

MeSH terms

  • Anticonvulsants / adverse effects
  • Benzodiazepines
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • Drug-Related Side Effects and Adverse Reactions* / etiology
  • Female
  • Humans
  • Male
  • Movement Disorders* / epidemiology
  • Movement Disorders* / etiology
  • Quality of Life
  • United States
  • United States Food and Drug Administration

Substances

  • Benzodiazepines
  • Anticonvulsants