Epilepsia, 54(1):199–203, 2013
doi: 10.1111/j.1528-1167.2012.03688.x
SPECIAL REPORT
Antiepileptic drugs and suicidality: An expert consensus
statement from the Task Force on Therapeutic Strategies of
the ILAE Commission on Neuropsychobiology
*Marco Mula, yAndres M. Kanner, zBettina Schmitz, and xSteven Schachter
*Amedeo Avogadro University, Novara, Italy; yRush Medical College at Rush University, Chicago, Illinois, U.S.A.;
zVivantes Humboldt-Klinikum, Berlin, Germany; and xBeth Israel Deaconess Medical Center,
Harvard University, Boston, Massachusetts, U.S.A.
SUMMARY
In 2008, the U.S. Food and Drug Administration (FDA)
issued an alert to health care professionals about an
increased risk of suicide ideation and suicide behavior in
people treated with antiepileptic drugs (AEDs). Since
then, a number of retrospective cohort and case–control
studies have been published that are trying to address this
issue, but gathered results are contradictory. This report
represents an expert consensus statement developed by
an ad hoc task force of the Commission on Neuropsychobi-
ology of the International League Against Epilepsy (ILAE).
Although some (but not all) AEDs can be associated with
treatment-emergent psychiatric problems that can lead
to suicidal ideation and behavior, the actual suicidal risk is
yet to be established, but it seems to be very low. The risk
of stopping AEDs or refusing to start AEDs is significantly
In 2008, the U.S. Food and Drug Administration (FDA)
issued an alert to health care professionals about an
increased risk of suicide ideation and behavior in people
treated with antiepileptic drugs (AEDs) (FDA 2008a). Such
a conclusion came from a meta-analysis of multicenter-
randomized placebo controlled trials of 11 AEDs. Pharma-
ceutical companies had been previously asked to submit
data from these trials, with at least 30 patients involved,
regardless of indication. Spontaneously reported suicidality
occurring during double-blind trials with an AED (or within
1 day of stopping) were sought and categorized. Data were
provided on the use of carbamazepine, felbamate, gabapen-
tin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin,
tiagabine, topiramate, valproate, and zonisamide used for
epilepsy (25% patients), psychiatric indications (27%
Accepted August 6, 2012; Early View publication September 20, 2012.
Address correspondence to Marco Mula, Division of Neurology, Uni-
versity Hospital Maggiore della Carit, C.so Mazzini, 18, 28100 Novara,
Italy. E-mail: marco.mula@med.unipmn.it
Wiley Periodicals, Inc.
ª 2012 International League Against Epilepsy
199
worse and can actually result in serious harm including
death to the patient. Suicidality in epilepsy is multifacto-
rial, and different variables are operant. Clinicians should
investigate the existence of such risk factors and adopt
appropriate screening instruments. If necessary, patients
should be referred for a psychiatric evaluation, but AED
treatment should not be withheld, even in patients with
positive suicidal risks. When starting an AED or switching
from one to other AEDs, patients should be advised to
report to their treating physician any change in mood and
suicidal ideation. Data on treatment-emergent psychiatric
adverse events need to be collected, in addition to general
safety information, during controlled studies in order to
have meaningful information for patients and their rela-
tives when a new drug is marketed.
KEY WORDS: Epilepsy, Suicide, Antiepileptic drugs,
Depression.
patients), and ‘‘other conditions’’ (48% patients). In the
main analysis, almost 28,000 people taking AEDs and
>16,000 people taking placebo were considered. There were
four completed suicides altogether, all in people taking
AEDs and none in those taking placebo. The FDA con-
cluded that patients receiving AEDs were significantly more
likely to experience suicidal behavior or ideation compared
with placebo (odds ratio [OR] 1.8; 95% confidence interval
[CI] 1.24–2.66). In addition, they observed that the relative
risk (RR) versus placebo was higher in patients treated for
epilepsy (RR 3.6; 95% CI 1.3–12.1) than for selected psy-
chiatric illnesses (RR 1.6; 95% CI 1–2.4) or other condi-
tions (e.g., migraine and neuropathic pain; RR 2.0; 95% CI
0.8–4.8) (FDA 2008b) where RR were not significant. As a
result of the analysis, the FDA required that all manufactur-
ers of drugs in this class include a warning in their labeling
and develop a medication guide for patients, informing them
of the risks of suicidal thoughts or actions. The FDA also
suggested that the warning language be carefully worded
and that it mention the risk of not treating the underlying
condition (Busco, 2008).
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M. Mula et al.
The FDA data was received with great skepticism by clini-
cians and the professional societies, including the American
Epilepsy Society, and some investigators questioned the
validity of its findings, after identifying serious methodologic
flaws (Hesdorffer & Kanner, 2009) and suggested that the
FDA’s concern might have been excessive (Hesdorffer &
Kanner, 2009; Mula et al., 2010), and that the risk of stop-
ping (or not even starting) AEDs in people with epilepsy
would be far greater than this hypothetic small increased risk
of suicidality (Mula & Sander, 2010). The International Lea-
gue Against Epilepsy (ILAE) appointed a Task Force under
the Commission on Neuropsychobiology to formulate a pro-
posal for a consensus on treatment issues in patients with epi-
lepsy and psychiatric problems. Members of this task force
(MM, BS, AMK) have been selected according to the follow-
ing criteria: (1) to be boarded in both adult neurology and
adult psychiatry with certified clinical practice in adult neu-
rology and adult psychiatry; (2) to work in an epilepsy center
as an epileptologist as main clinical practice; (3) to have pub-
lished relevantly in epileptology and neuropsychiatry of epi-
lepsy. An additional member (SS) has been included as a
liaison with the ILAE Commission on Therapeutic strategies.
The present article represents an expert consensus statement
on the issue of suicide during treatment with AEDs. Refer-
ences were identified by searches of Medline/PubMed using
the terms ‘‘epilepsy,’’ ‘‘antiepileptic drugs,’’ ‘‘suicide.’’ Only
articles published in English in international peer-reviewed
journals were considered. The reference list of relevant arti-
cles was hand-searched for additional publications (e.g.,
book chapters or review papers) if relevant to the discussion.
Abstracts of presentations, even from international con-
gresses, have not been included. Discussions at international
workshops have been considered (Kanner et al., 2012).
Limits of the FDA Meta-Analysis
An analysis of the FDA document demonstrates several
methodologic flaws, which include:
1 The assessment of suicidality was based on ‘‘spontane-
ous’’ reports of patients and not gathered in a systematic
prospective manner in every patient who was randomized
to study drug or placebo (Hesdorffer & Kanner, 2009;
Hesdorffer et al., 2010).
2 The FDA’s warning indicates an increased risk of suicide
with all AEDs, despite the fact that statistical significance
was found in only 2 (i.e., topiramate and lamotrigine) of
the 11 AEDs studied. Furthermore, inclusion of three
additional studies of lamotrigine resulted in the loss of
statistical significance for this AED. Two other AEDs,
valproic acid and carbamazepine, actually yielded a
‘‘small protective effect.’’ The FDA’s decision to present
the risk as involving all AEDs stemmed from a concern
that singling out specific AEDs might have changed pre-
scribing practices, rather than emphasize the suicide risk,
a reasoning that was not based on scientific facts.
Epilepsia, 54(1):199–203, 2013
doi: 10.1111/j.1528-1167.2012.03688.x
3 Most epilepsy trials (92%) included patients taking
adjunctive therapy (compared with 14% of psychiatric
trials and 15% of other medical trials). It is, thus, unclear
whether the higher suicidality rates in the epilepsy trials
were due to drug interactions, given the high proportion
of epilepsy trials designed with polytherapy, or whether
they potentially were due to the low suicidality risk asso-
ciated with carbamazepine and valproate—both drugs are
the most common comparison drugs in these trials and
demonstrated favorable psychotropic properties (Ettin-
ger, 2006).
4 Suicidal behavior was greater in certain geographic
regions. For example, the odds ratio of suicidality was
1.38 (95% CI 0.9–2.13) in North American studies and
4.53 (95% CI 1.86–13.18) in studies done elsewhere.
Such differences strongly suggest serious methodologic
errors in data gathering (Hesdorffer & Kanner, 2009;
Hesdorffer et al., 2010).
Available Evidence on AEDs
and Suicide
In the last 3 years, a number of retrospective cohort and
case–control studies, using observational study methodol-
ogy, investigated whether or not there is an association
between AEDs and suicidality (Gibbons et al., 2009, 2010;
Andersohn et al., 2010; Arana et al., 2010; Olesen et al.,
2010; Patorno et al., 2010; VanCott et al., 2010; Redden
et al., 2011). The majority of studies included data from
patients with epilepsy, whereas some authors focused on
psychiatric subjects only (Gibbons et al., 2009). In general
terms, results are contradictory among the studies, with
some studies reporting an increased suicidality risk (Ander-
sohn et al., 2010; Olesen et al., 2010; Patorno et al., 2010;
VanCott et al., 2010) and others observing no increased
risk (Arana et al., 2010; Gibbons et al., 2010). However,
all of these studies are being affected by a number of limi-
tations (Hesdorffer et al., 2010; Mula & Hesdorffer, 2011)
such as the failure to adjust for past suicidal behaviors
(Andersohn et al., 2010; Olesen et al., 2010). In one study,
the authors adjusted for a history of self-harm that does not
imply suicidal behavior, being two different entities from a
psychopathologic point of view (Mula & Hesdorffer,
2011). Another study took into account past suicidality but
over an unspecified period of time (VanCott et al., 2010),
whereas other authors (Arana et al., 2010; Patorno et al.,
2010) excluded subjects with a past history, or family his-
tory (Arana et al., 2010), of suicidality before the study
entry. The issue of a past history of suicide behavior repre-
sents an important variable because suicide is a highly
recurrent phenomenon (between 14% and 17% after 1 year
and >30% over 10 years) (Owens et al., 2002; Kapur et al.,
2006) and because prescribing practices may be influenced
by prior suicidal behaviors (Hesdorffer et al., 2010; Mula
& Hesdorffer, 2011), considering that some AEDs are

thought to have positive effects on mood and others nega-
tive (Ettinger, 2006). Therefore, in the absence of adjust-
ment for prior suicidal behavior, it is impossible to
determine, from the published studies, whether AEDs are
associated with suicidal behavior (Mula & Hesdorffer,
2011).
The Issue of Suicide in Epilepsy
In the general population, suicide represents the 11th
cause of death and the second in the group aged 25–
34 years (Gelder, 2009). It is more common in men than in
women, particularly in developed countries, whereas
attempted suicide is more represented among females (Sa-
dock et al., 2009). In patients with epilepsy, the overall risk
of committing suicide is about three times higher than that
of the general population (Harris & Barraclough, 1997;
Christensen et al., 2007; Bell et al., 2009). Several studies
have attempted to identify reasons for such an increased
risk. In fact, suicidality and epilepsy have a complex rela-
tion, based on several variables. In the general population,
about 90% of people who successfully commit suicide have
at least one psychiatric disorder at that time (Barraclough,
1987). Epilepsy can be complicated by psychiatric comor-
bidities, but it is unlikely that such comorbidity is the only
responsible element. A Danish study pointed out that the
rate ratio of suicide in people with epilepsy is still doubled
even after excluding people with psychiatric comorbidity
and adjusting for various factors and that it increases by
32-fold in the presence of comorbid mood disorders and by
12-fold in the presence of anxiety disorders and schizo-
phrenia. Some have suggested a link with temporal lobe
epilepsy (Harris & Barraclough, 1997). However, a recent
study, using retrospective and prospective methods, found
no epilepsy-related factors (Hara et al., 2009). Postictal sui-
cidal ideation is relatively frequent in patients with treat-
ment-resistant partial epilepsy, having been identified in
13% of 100 consecutive patients with a median duration of
24 h (Kanner et al., 2004). Furthermore, a bidirectional
relation has been identified between suicidality and
epilepsy, whereby patients with a history of suicidal behav-
ior have a fivefold higher risk of developing epilepsy in a
population-based study conducted in Iceland (Hesdorffer
et al., 2006). This bidirectional relation raises the question
of common pathogenic mechanisms operant in both
conditions such as serotonin dysfunction, a hyperactive
hypothalamic-pituitary-adrenal axis, as well as glutamate
and c-aminobutyric acid (GABA)-ergic disturbances
(Hecimovic et al., 2011).
In conclusion, all the complexities of the relation between
epilepsy and suicide are still far from being elucidated, but
they are clearly multifactorial with biologic, constitutional,
and psychosocial variables being implicated. Yet, given the
increased risk of suicide in patients with epilepsy, screening
for suicide is a relevant issue.
201
Antiepileptic Drugs and Suicidality
Psychiatric Adverse Events of
AEDs in Patients with Epilepsy
The psychotropic potential of AEDs in patients with epi-
lepsy is related to direct and indirect mechanisms (Mula &
Sander, 2007). A number of studies suggest that treatment
with some AEDs is associated with the occurrence of symp-
toms of depression (Table 1), whereas other compounds
have positive psychotropic properties. As far as first-genera-
tion compounds are concerned, authors agree that there is a
link between barbiturates and depression, whereas carba-
mazepine probably has mood stabilizing and antimanic
effects (Rodin et al., 1976; Dodrill & Troupin, 1977;
Robertson & Trimble, 1983). Among second-generation
AEDs, vigabatrin (Levinson & Devinsky, 1999), tiagabine
(Trimble et al., 2000), and topiramate (Mula et al., 2003a)
have been linked to treatment-emergent depressive
symptoms, whereas levetiracetam with dysphoria and mood
lability (Mula et al., 2003b).
In some cases, treatment-emergent depressive symptoms
are associated with a sudden complete control of seizures
(the forced normalization phenomenon) (Ring et al., 1993),
whereas in others they are unrelated to this. Nevertheless, a
rapid titration of the drug (Mula et al., 2009) in patients with
drug-refractory mesial temporal lobe epilepsy and a past
history of depression (Mula et al., 2007) have been identi-
fied as major determinants in the majority of cases. Particu-
larly, several studies pointed out that the development of
psychiatric adverse events (which could potentially facili-
tate the occurrence of suicidal ideation and behavior) is
more likely in patients at risk of developing psychiatric
disorders, either because of a past psychiatric history or a
family psychiatric history (Kanner et al., 2003; Mula et al.,
2007).
Conclusions
1 Although some (but not all) AEDs can be associated with
treatment-emergent psychiatric problems that can lead to
suicidal ideation and behavior, the actual suicidal risk is
yet to be established, but it seems to be very low. The risk
of stopping AEDs or refusing to start AEDs is signifi-
cantly worse and can actually result in serious harm
Table 1. Treatment-emergent psychiatric adverse
events of AEDs in patients with epilepsy
Depression Psychoses Irritability/Emotion lability
Barbiturates Ethosuximide Felbamate
Tiagabine Levetiracetam Lamotrigine
Topiramate Phenytoin (toxic levels) Levetiracetam
Vigabatrin Topiramate
Zonisamide Vigabatrin
Zonisamide
Epilepsia, 54(1):199–203, 2013
doi: 10.1111/j.1528-1167.2012.03688.x
202
M. Mula et al.
including death to the patient (Hesdorffer et al., 2011;
Ryvlin et al., 2011).
2 Suicidality in epilepsy is multifactorial. Major operant
variables include the following: (1) postictal suicidal ide-
ation; (2) a past and/or current history of psychiatric dis-
orders, particularly mood and anxiety disorders (and
above all when associated with prior suicidal attempts);
(3) a family history of mood disorder complicated with
suicidal attempts. Notably, suicide attempts preceding
the onset of the epilepsy need to be taken into account.
Given the above risks, clinicians should investigate the
existence of such risk factors and if necessary, refer the
patient for a psychiatric evaluation, but not withhold
treatment even in patients with positive suicidal risks.
3 When starting an AED or switching from one to other
AEDs, patients should be advised to report any changes
in mood and suicidal ideation to their treating physician.
In fact, despite the uncertainty, the FDA alert remains
active and clinicians need to screen patients they start on
AEDs. The Columbia Suicide Severity Rating Scale
(C-SSRS) represents a suitable and reliable instrument to
evaluate suicidality (Posner et al., 2011) and it is avail-
able in several languages (Korean, Japanese, Chinese,
Afrikaans, French, Bulgarian, Czech, Dutch for Belgium,
Dutch for The Netherlands, English, English for South
Africa, Estonian, Finnish, German for Austria, Korean,
Lithuanian, Turkish, Swedish, Spanish for U.S.A., Span-
ish for Mexico, Polish, Malay, Greek, Hungarian, Italian,
German, and Romanian).
4 Data on treatment-emergent psychiatric adverse events
need to be collected, in addition to general safety infor-
mation, during controlled studies in order to inform
patients and their relatives when drugs are marketed. A
detailed family and personal history of psychiatric disor-
ders, a previous history of suicidal behaviors (even before
the onset of the epilepsy), and a screening for suicide
using the C-SSRS need to be included in any controlled
trial of new AEDs in epilepsy.
Acknowledgments
This report was written by experts selected by the International League
Against Epilepsy (ILAE) and was approved for publication by the ILAE.
Opinions expressed by the authors, however, do not necessarily represent
official policy or position of the ILAE.
Disclosure
MM has received consultancy fees from Pfizer, UCB Pharma, and
Janssen. AMK has received research funding from Pfizer, Novartis, and
GlaxoSmithKline. BS has received consultancy fees from GlaxoSmithK-
line, UCB Pharma, Janssen, Desitin, Pfizer, Eisai, Novartis, and Sanofi.
SS has been compensated by Cyberonics, Insero Health, and Sage thera-
peutics for giving scientific guidance for the further clinical development
of devices and compounds for the diagnosis and treatment of epilepsy.
We confirm that we have read the Journal’s position on issues involved
in ethical publication and affirm that this report is consistent with those
guidelines.
Epilepsia, 54(1):199–203, 2013
doi: 10.1111/j.1528-1167.2012.03688.x
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