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• W3163268700 abstract "On Oct 9, 2020, the US Food and Drug Administration (FDA) issued a warning on the lamotrigine datasheet including this statement: “avoid LAMICTAL (ie, lamotrigine) in patients with certain underlying cardiac disorders or arrhythmias”.1French JA Perucca E Sander JW et al.FDA safety warning on the cardiac effects of lamotrigine: an advisory from the Ad Hoc ILAE/AES Task Force.Epilepsia Open. 2021; 6: 45-48Crossref PubMed Scopus (6) Google Scholar According to the update, the drug might have class Ib antiarrhythmic activity at therapeutically relevant concentrations. This effect could result in a widening of the QRS complex, induce new cardiac arrhythmias, and lead to sudden death. The warning also stated that lamotrigine should be avoided in individuals with cardiac conduction abnormalities, ventricular arrhythmias, or structural heart disease. The updated FDA warning, however, is based on in-vitro data. Studies in healthy individuals have suggested that lamotrigine does not cause QT prolongation, but only mild PR interval increases, with unclear clinical relevance.1French JA Perucca E Sander JW et al.FDA safety warning on the cardiac effects of lamotrigine: an advisory from the Ad Hoc ILAE/AES Task Force.Epilepsia Open. 2021; 6: 45-48Crossref PubMed Scopus (6) Google Scholar The use of epilepsy and antiseizure medication appears to be associated with sudden death.2Surges R Shmuely S Dietze C Ryvlin P Thijs RD Identify patients with epilepsy at high risk of cardiac death: recognise signs, risk factors and initial management of high risk of cardiac death.Epileptic Disord. 2021; 23: 17-39Crossref PubMed Scopus (7) Google Scholar One sizeable case-control study suggested that sodium channel blockers were associated with an increased risk of sudden cardiac death.3Bardai A Blom MT van Noord C Verhamme KM Sturkenboom MC Tan HL Sudden cardiac death is associated both with epilepsy and with use of antiepileptic medications.Heart. 2015; 101: 17-22Crossref PubMed Scopus (35) Google Scholar This association was mainly driven by carbamazepine and gabapentin. Notably, cases of sudden cardiac death most likely included instances of sudden unexpected death in epilepsy. None of the 14 patients who died in this cohort was, however, taking lamotrigine. An analysis of more than 40 randomised controlled trials of lamotrigine, in which 12 potential cases of sudden unexpected death in epilepsy occurred, did not identify a significant association between lamotrigine exposure and sudden unexpected death in epilepsy.4Tomson T Hirsch LJ Friedman D et al.Sudden unexpected death in epilepsy in lamotrigine randomised-controlled trials.Epilepsia. 2013; 54: 135-140Crossref PubMed Scopus (39) Google Scholar There are many reports in the scientific literature of electrocardiogram changes in people with epilepsy, but associations with the use of antiseizure medication are often disputed. In the case of lamotrigine, concerns that it might have proarrhythmogenic potential have generated considerable discussion within the epilepsy community. This proarrhythmogenic effect might not be limited to lamotrigine, as there are indications that it could be a class effect of sodium channel blockers. Particularly, carbamazepine, lacosamide, and phenytoin have been associated with bradyarrhythmias and atrioventricular conduction delays, mostly in older individuals (>60 years) and people with pre-existing cardiac conduction disorders.2Surges R Shmuely S Dietze C Ryvlin P Thijs RD Identify patients with epilepsy at high risk of cardiac death: recognise signs, risk factors and initial management of high risk of cardiac death.Epileptic Disord. 2021; 23: 17-39Crossref PubMed Scopus (7) Google Scholar Lamotrigine and carbamazepine are among the medications that are preferentially avoided for people with Brugada syndrome. Lacosamide has occasionally been implicated in atrial fibrillation and atrial flutter, again predominantly in older people.2Surges R Shmuely S Dietze C Ryvlin P Thijs RD Identify patients with epilepsy at high risk of cardiac death: recognise signs, risk factors and initial management of high risk of cardiac death.Epileptic Disord. 2021; 23: 17-39Crossref PubMed Scopus (7) Google Scholar In individuals with sodium channel mutations, sodium channel blockers should be avoided. For example, in people with Dravet syndrome (associated with SCN1A mutations), sodium channel blockers are often ineffective as a treatment for epilepsy. The use of sodium channel blockers can also lead to poor cognitive outcomes, particularly in children.5de Lange IM Gunning B Sonsma AC et al.Influence of contraindicated medication use on cognitive outcome in Dravet syndrome and age at first afebrile seizure as a clinical predictor in SCN 1A-related seizure phenotypes.Epilepsia. 2018; 59: 1154-1165Crossref PubMed Scopus (44) Google Scholar Following the FDA's update, an ad-hoc joint task force of the International League against Epilepsy and the American Epilepsy Society extensively reviewed the available evidence to advise health-care professionals on minimising cardiac safety risks that are associated with lamotrigine use (panel). Given the importance of lamotrigine in the management of epilepsy, its use in people with low to no risk of structural heart disease should not be discouraged. Clinical data and experience with lamotrigine accumulated over more than three decades have left clinicians confident in its safety and efficacy. We are heartened by a new FDA communication that was released on March 31, 2021, after the joint task force's review.1French JA Perucca E Sander JW et al.FDA safety warning on the cardiac effects of lamotrigine: an advisory from the Ad Hoc ILAE/AES Task Force.Epilepsia Open. 2021; 6: 45-48Crossref PubMed Scopus (6) Google Scholar This new advisory removes the recommendation to avoid lamotrigine for people with some underlying cardiac disorders or arrhythmias, and emphasises the risk of stopping the drug abruptly and the need to weigh potential lamotrigine risks against its well established benefits (eg, low teratogenic potential in women of child-bearing age, high tolerability, and modest drug–drug interactions in older adults). Further studies are needed to establish whether the preclinical findings that resulted in this label update translate to an increased risk of cardiological side-effects in people with structural heart disease.PanelAdvisory in response to the US Food and Drug Administration safety warning on the cardiac effects of lamotrigineThe International League Against Epilepsy and the American Epilepsy Society Task Force has published its recommendations regarding which measures to take when prescribing lamotrigine.6Ad Hoc International League Against Epilepsy and the American Epilepsy Society Task ForceFDA safety warning on the cardiac effects of lamotrigine: an advisory from the Ad Hoc ILAE/AES Task Force.https://www.ilae.org/files/ilaeGuideline/ILAE_AES_Lamotrigine-advisory-FINAL-2021-0126.pdfDate: Jan 26, 2021Date accessed: April 12, 2021Google Scholar The task force emphasised that the likelihood of asymptomatic cardiac disease is low among individuals younger than 60 years without cardiovascular risk factors or symptoms. Therefore, no additional precautions were recommended with the initiation of lamotrigine. The task force recommended that a cardiologist's opinion should be considered before starting lamotrigine in people with comorbid cardiac conditions. In people older than 60 years, an electrocardiogram should be done on lamotrigine initiation. Members of the task force argued that it is unnecessary to delay lamotrigine initiation but that the electrocardiogram should be requested as lamotrigine is initiated. A driver for this assertion is that any lamotrigine effect on cardiac conduction is dose-dependent, and the generally slow initiation strategy that is used with lamotrigine is a mitigating factor. The International League Against Epilepsy and the American Epilepsy Society Task Force has published its recommendations regarding which measures to take when prescribing lamotrigine.6Ad Hoc International League Against Epilepsy and the American Epilepsy Society Task ForceFDA safety warning on the cardiac effects of lamotrigine: an advisory from the Ad Hoc ILAE/AES Task Force.https://www.ilae.org/files/ilaeGuideline/ILAE_AES_Lamotrigine-advisory-FINAL-2021-0126.pdfDate: Jan 26, 2021Date accessed: April 12, 2021Google Scholar The task force emphasised that the likelihood of asymptomatic cardiac disease is low among individuals younger than 60 years without cardiovascular risk factors or symptoms. Therefore, no additional precautions were recommended with the initiation of lamotrigine. The task force recommended that a cardiologist's opinion should be considered before starting lamotrigine in people with comorbid cardiac conditions. In people older than 60 years, an electrocardiogram should be done on lamotrigine initiation. Members of the task force argued that it is unnecessary to delay lamotrigine initiation but that the electrocardiogram should be requested as lamotrigine is initiated. A driver for this assertion is that any lamotrigine effect on cardiac conduction is dose-dependent, and the generally slow initiation strategy that is used with lamotrigine is a mitigating factor. NH and JWB declare no competing interests. RDT receives research support from Medtronic; fees as speaker or consultant from Theravance Biopharma and Arvelle Therapeutics; and lecture fees from Medtronic, UCB, and Novartis. MRK reports unrestricted educational grants and research grants for investigator-initiated studies from UCB and Eisai. JWS reports fees as speaker or consultant from Eisai, UCB, GW Pharmaceuticals, Arvelle, and Zogenix. RDT received research support from the Dutch Epilepsy Foundation, De Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie, and the Netherlands Organization for Health Research and Development. JWS is based at University College London Hospital and University College London Comprehensive Biomedical Research Centre, which receives a proportion of funding from the UK Department of Health's National Institute for Health Research Biomedical Research Centres funding scheme. JWS receives support from the Dr Marvin Weil Epilepsy Research Fund, the Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie, and the UK Epilepsy Society." @default.
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• W3163268700 title "Concerns about lamotrigine" @default.
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