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ARTICLES: Bassel F. Shneker, Jacquelyne S. Cios, and John O. Elliott Suicidality, depression screening, and antiepileptic drugs: Reaction to the FDA alert Neurology 2009; 72: 987-991 [Abstract] [Full text] [PDF]

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Suicidality, depression screening, and antiepileptic drugs: Reaction to the FDA alert

Abdorasool Janati, Alexandria, VA 22314   (22 June 2009)

Reply from the authors

Bassel F. Shneker, Jacquelyne S. Cios, John O. Elliott   (22 June 2009)

Suicidality, depression screening, and antiepileptic drugs: Reaction to the FDA alert 22 June 2009
Abdorasool Janati, FAAN 1202 S. Washington St. #508C, Alexandria, VA 22314 Send Correspondence to journal: Re: Suicidality, depression screening, and antiepileptic drugs: Reaction to the FDA alert brucejanatimd{at}aol.com Abdorasool Janati, et al.	I read with interest the article by Shneker et al. [1] After conducting a survey of a group of neurologists—primarily epileptologists—the authors concluded that the participants were not particularly alarmed by the FDA alert concerning suicidal ideation/behavior and anticonvulsants (AEDs). [2] Depression and suicidal behavior are more prevalent in epileptics compared to the normal population. [3] Precipitating factors include: psychosocial issues, genetic predisposition, newly diagnosed epilepsy, ongoing epileptic syndrome (particularly symptomatic epilepsy), fear, and certain personality traits. Other variables have also been reported including: seizure chronicity, seizure type, laterality of the epileptogenic zone, gender, and seizure frequency. [4] A possible role for AEDs in the etiology of interictal depression/suicidal ideation in epileptics has been suspected by experts [2] yet conclusive data are lacking. In the 1960s and 1970s, several epilepsy experts found that some epileptic patients—particularly those with generalized convulsive seizures—became more depressed once their seizures were successfully managed. [5] Inversely, when more seizures occurred, the affective symptoms improved. To explain this “quasi see-saw” relationship between seizure frequency and severity of depression, the epileptologists used the efficacy of electroconvulsive therapy in severe depression as an analogy. It is conceivable that in the FDA study, the high incidence of suicidal ideation/behavior attributed to AEDs were partially the result of the seizure control achieved by these agents and not due to direct medication effect. This topic should be revisited due to the significant practical implications. Therefore, future studies should consider seizure frequency and seizure type as factors in the investigation of affective symptoms in epilepsy. References 1. Shneker BF, Cios JS, Elliott JO. Suicidality, depression screening, and anti-epileptic drugs. Neurology 2009;72:987-991. 2. Busko M. FDA advisory members agree antiepileptics pose suicidality risk, nix need for black-box warning. Available at: http://www.medscape.com/viewarticle/577432. Accessed October 31, 2008. 3. Hawton K, Fagg J, Marsack P. Association between epilepsy and attempted suicide. J Neurol Neurosurg Psychiatry 1980;43:168-170. 4. Vasilios KK, Nikolaos IT, Eleni K, et al. Depression and anxiety in epilepsy: The association with demographic and seizure related variables. Ann Gen Psychiatry 2007;6:28 5. Engel J, Aicardi J, Pedley TA, et al. Epilepsy: A comprehensive textbook. New York. Lippincott, Williams and Wilkins 2007. The author reports no disclosures.
Reply from the authors 22 June 2009
Bassel F. Shneker, Ohio State University 395 W. 12th Avenue, 7th Floor, Columbus, OH 43210, Jacquelyne S. Cios, John O. Elliott Send Correspondence to journal: Re: Reply from the authors shneker.1{at}osu.edu Bassel F. Shneker, et al.	We appreciate Janati’s comments regarding our recent article. [1] Our objective was not to re-analyze the data the Food and Drug Administration (FDA) used to issue the alert or to explain the findings. [6] We intended to capture the reaction of practitioners to the alert. If anti-epileptic drugs (AEDs) increase the risk of suicidality independent of any other factors, it is important to determine the reasons for an increase. It could be attributed to the improvement of seizure control, not the AEDs, as Janati has suggested. This hypothesis could be relevant if the majority of epilepsy patients in the analyzed data achieved seizure freedom. However, that was not the case in the analyzed epilepsy clinical trials. In addition, such a hypothesis does not explain why the FDA found an increased risk of suicidality when AEDs were used to treat other conditions like psychiatric disorders, pain, and migraine. Only future prospective studies looking at AEDs and the characteristics of the diseases for which they were used may explain the concerns raised by the FDA alert. Reference 6. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: suicidality and antiepileptic drugs. Available at: http://www.fda.gov/Cder/Drug/InfoSheets/HCP/antiepilepticsHCP.htm. Accessed May 18, 2009. Disclosures: Dr. Schneker received a research grant from the Gustavus and Louise Pfeiffer Research Foundation, received grants from UCB pharma, Pfizer, J&J, Eisai, Marinus, GSK, and Jazz and received honoraria for serving on a scientific advisory board for UCB Pharma. Drs Cios and Elliott report no disclosures.