FDA black box warning for an increased risk of suicidality for antiepileptic drugs

FDA black box warning for an increased risk of suicidality for antiepileptic drugs

Why did the FDA issue a black box warning for an increased risk of suicidality for antiepileptic drugs (AEDs)?

Do antiepileptic drugs increase the risk for depression and suicide in epilepsy? 

The FDA’s black box warning is based on a 2008 meta-analysis finding of a nearly twofold increase in suicidal ideation or behavior associated with AED use.

This issue has remained controversial due to the study’s limitations and the fact that epilepsy itself increases the risk for depression and suicide.

A more recent systematic review and large population-based study found that AED use may actually decrease the risk of suicide for people with epilepsy.

However, AED use was associated with increased risk of suicide-related behavior for people with depression or other disorders (but not bipolar disorder).

Several AEDs (e.g., barbiturates, felbamate, levetiracetam, tiagabine, topiramate, vigabatrin, zonisamide) may be particularly prone to inducing depression.

The best predictor of suicide in epilepsy is comorbid depression, and this necessitates routine screening and treatment for patients with depression.

Sources

  • Sadock BJ, Sadock VA, Belkin GS (eds): Kaplan & Sadock’s pocket handbook of clinical psychiatry, 5th ed. Philadelphia: Lippincott Williams & Wilkins, 2010, pp 332-335.
  • Gehl C, Paulsen JS: Behavior and personality disturbances. In Daroff RB, Bradley WG (eds): Bradley’s neurology in clinical practice. Philadelphia: Elsevier, 2012, pp 83-86.
  • Homaifar B, Matarazzo B, Wortzel HS: Therapeutic risk management of the suicidal patient: augmenting clinical suicide risk assessment with structured instruments. J Psychiatr Pract 19(5):406-409, 2013.
  • Griffiths JJ, Zarate CA Jr., Rasimas JJ: Existing and novel biological therapeutics in suicide prevention. Am J Prev Med 47(3 Suppl 2):S195-S203, 2014.
  • Ferrer P, Ballarín E, Sabaté M, et al.: Antiepileptic drugs and suicide: a systematic review of adverse effects. Neuroepidemiology 42(2):107-120, 2014.
  • Arana A, Wentworth CE, Ayuso-Mateos JL, Arellano FM: Suicide-related events in patients treated with antiepileptic drugs. N Engl J Med 363:542-551, 2010.
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