The FDA alert on suicidality and antiepileptic drugs

Fire or false alarm?

Dale C. Hesdorffer, Andres M Kanner

Research output: Contribution to journalArticle

115 Citations (Scopus)

Abstract

In January 2008, the U.S. Food and Drug Administration (FDA) issued an alert about an increased risk for suicidality in 199 clinical trials of 11 antiepileptic drugs (AEDs) for three different indications, including epilepsy. An advisory panel voted against a black-box warning on AED labels, and the FDA has accepted this recommendation. We discuss three potential problems with the alert. First, adverse event data were used rather than systematically collected data. Second, the 11 drugs grouped together as a single class of AEDs have different mechanisms of action and very different relative risks, many of which were not statistically significant and some of which were smaller than one. These facts suggest that they should not be grouped as a class. Third, the risk of adverse effects from uncontrolled seizures almost certainly outweighs the small risk of suicidality. We place our comments in the context of a review of the literature on suicidality and depression in epilepsy and the sparse literature on AEDs and suicidality. We recommend that all patients with epilepsy be routinely evaluated for depression, anxiety, and suicidality, and that future clinical trials include validated instruments to systematically assess these conditions to determine whether the possible signal observed by the FDA is real.

Original languageEnglish (US)
Pages (from-to)978-986
Number of pages9
JournalEpilepsia
Volume50
Issue number5
DOIs
StatePublished - May 2009
Externally publishedYes

Fingerprint

United States Food and Drug Administration
Anticonvulsants
Epilepsy
Drug Labeling
Clinical Trials
Depression
Seizures
Anxiety
Pharmaceutical Preparations

Keywords

  • Antiepileptic drugs
  • FDA alert
  • Suicidality

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

The FDA alert on suicidality and antiepileptic drugs : Fire or false alarm? / Hesdorffer, Dale C.; Kanner, Andres M.

In: Epilepsia, Vol. 50, No. 5, 05.2009, p. 978-986.

Research output: Contribution to journalArticle

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