Side Effects of rufinamide: A Synthesis of Findings from 23 Studies

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Original Abstract of the Article

Major Research Findings

Rufinamide has been shown to be effective in reducing seizures in patients with Lennox-Gastaut syndrome (LGS) in several studies. 23 、 19 、 18 、 17 、 6 、 7 It is particularly effective in reducing the frequency of drop seizures, a common and severe seizure type in LGS. 23 、 6 However, it has been found to be less effective in Dravet syndrome, another severe epilepsy syndrome in children. 14

Reason for Side Effects

Rufinamide is thought to work by prolonging the inactivation phase of voltage-gated sodium channels, which are involved in the transmission of nerve impulses in the brain. 6 This mechanism of action may also contribute to some of the side effects observed with rufinamide.

Common Side Effects

Somnolence

Somnolence (sleepiness) is a common side effect of rufinamide, reported in several studies. 21 、 18 、 17 、 6 It is thought to be related to the drug's effect on the central nervous system. 6

Headache

Headache is another common side effect of rufinamide. 21 、 18 、 6 The cause of headache is not fully understood, but it may be related to the drug's effect on the central nervous system. 6

Nausea

Nausea is also a common side effect of rufinamide. 21 、 18 、 17 、 6 It may be related to the drug's effect on the digestive system. 6

Vomiting

Vomiting is another common side effect of rufinamide. 21 、 18 、 17 、 6 It may be related to the drug's effect on the digestive system. 6

Fatigue

Fatigue is also reported as a side effect of rufinamide. 6 This may be related to the drug's effect on the central nervous system. 6

Countermeasures for Side Effects

Somnolence

Somnolence due to rufinamide can often be managed by adjusting the timing of medication administration. For instance, taking it at bedtime may minimize daytime drowsiness. 6 If side effects are persistent, discussing a change in medication with your doctor may be beneficial. 6

Headache

Over-the-counter painkillers can often effectively address headaches caused by rufinamide. However, it is crucial to consult with your doctor before taking any new medications. 6 If headaches are severe or persistent, discussing a change in medication with your doctor is recommended. 6

Nausea

Nausea associated with rufinamide can often be mitigated through dietary adjustments, such as eating smaller, more frequent meals. Anti-nausea medications may also provide relief. 6 As always, consulting with your doctor about persistent nausea is advised. 6

Vomiting

Similar to nausea, vomiting can often be managed through dietary changes and anti-nausea medications. If vomiting persists, your doctor can explore alternative medications or treatment options. 6

Fatigue

Ensuring adequate rest can help manage fatigue associated with rufinamide. If fatigue persists, consulting with your doctor to discuss potential alternative treatments is advised. 6

Comparison between studies

Common Points

Across numerous studies, rufinamide has consistently shown effectiveness in reducing seizure frequency in patients with LGS. 23 、 19 、 18 、 17 、 6 、 7 Furthermore, these studies generally indicate that rufinamide has a favorable safety profile, with most side effects being mild and transient. 21 、 18 、 17 、 6 、 7

Differences

The efficacy of rufinamide appears to vary depending on the specific epilepsy syndrome and the age of the patient. While showing effectiveness in LGS, its efficacy in Dravet syndrome is less pronounced. 14 Additionally, side effects can vary from person to person, highlighting the importance of individualizing treatment and monitoring. 21 、 18 、 17 、 6 、 7

Points to note for real-life application

Rufinamide, while offering potential benefit for epilepsy, is not universally effective, and side effects can occur. It is crucial to follow your doctor's instructions carefully and to report any new or worsening symptoms immediately. 6 Open communication with your doctor is key to ensure you receive the best possible care.

Limitations of current research

Research on the long-term effects of rufinamide, particularly regarding its potential side effects, is still limited. 6 Further research is needed to understand the full spectrum of long-term safety and efficacy of rufinamide.

Future research directions

Future research should focus on evaluating the long-term safety and efficacy of rufinamide, including its impact on various epilepsy syndromes and patient populations. 6 Investigation into combination therapies involving rufinamide and other antiepileptic drugs is also crucial.

Conclusion

Rufinamide presents a potentially effective treatment option for epilepsy, particularly LGS, but its effectiveness can vary. Side effects, while generally mild and transient, can occur. It is imperative to follow your doctor's instructions closely and report any concerns or side effects promptly. 6 Further research is necessary to better understand the long-term implications and optimize its use in various epilepsy contexts.

Literature analysis of 23 papers
Positive Content
21
Neutral Content
0
Negative Content
2
Article Type
3
1
0
8
23
1.

Adverse effects of risperidone and haloperidol treatment in schizophrenia.

Author: YenYung-Chieh, LungFor-Wey, ChongMian-Yoon

Improved negative symptoms
Extrapyramidal side effects

Risperidone was more effective than haloperidol in improving negative symptoms in patients with schizophrenia. Risperidone was also better tolerated. Serum prolactin levels could predict the severity of parkinsonism and dyskinesia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Metabolic risk with second-generation antipsychotic treatment: a double-blind randomized 8-week trial of risperidone and olanzapine.

Author: KellyDeanna L, ConleyRobert R, LoveRaymond C, MorrisonJohn A, McMahonRobert P

Psychotic treatment
Metabolic disturbances
Weight gain

This study examined weight and metabolic changes in patients treated with risperidone and olanzapine, two widely used second-generation antipsychotics. The study addressed the importance of early monitoring for metabolic side effects associated with these medications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

A double-blind placebo-controlled discontinuation study of zuclopenthixol for the treatment of aggressive disruptive behaviours in adults with mental retardation - secondary parameter analyses.

Author: HässlerF, GlaserT, PapA F, BenekeM, DiefenbacherA, ReisO,

Reduced aggression
Mild side effects

Zuclopenthixol proved to be safe and effective to keep a low rate of aggressive behaviour in adults with mental retardation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Efficacy of rufinamide in childhood refractory epilepsy.

Author: YıldızEdibe Pembegül, HızlıZeynep, BektaşGonca, Ulak-ÖzkanMelis, TatlıBurak, AydınlıNur, ÇalışkanMine, ÖzmenMeral

Refractory epilepsy treatment

This study evaluated the reliability of rufinamide and its impact on seizure frequency in patients diagnosed with drug-resistant epilepsy. The results showed that rufinamide was effective in patients with Lennox-Gestaut syndrome (LGS) and drop/attacks types of seizures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Stevens-Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: An analysis of the US Food and Drug Administration Adverse Event Reporting System.

Author: BorrelliEric P, LeeErica Y, DescoteauxAndrew M, KogutStephen J, CaffreyAisling R

AEDs risk
SJS/TEN

This study quantified the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) associated with antiepileptic drugs (AEDs) in the United States.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

6.

Rufinamide for the treatment of Lennox-Gastaut syndrome: evidence from clinical trials and clinical practice.

Author: StrianoPasquale, McMurrayRob, SantamarinaEstevo, FalipMercè

Lennox-Gastaut treatment
Dizziness risk
Fatigue risk
Headache risk
Nausea risk
Somnolence risk
Vomiting risk

This study examined the effectiveness and safety of rufinamide for the treatment of seizures associated with Lennox-Gastaut syndrome. Rufinamide has been shown to be effective in reducing the frequency of drop attacks and total seizures, with a favorable tolerability profile.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Cognitive and behavioral effects of new antiepileptic drugs in pediatric epilepsy.

Author: MoaveroRomina, SantaroneMarta Elena, GalassoCinzia, CuratoloPaolo

Improved behavior
Improved cognition

This paper discusses the impact of new and newest antiepileptic drugs on cognition and behavior in children with epilepsy. It aims to guide clinicians in choosing the most appropriate medication for epilepsy associated with specific neurodevelopmental disorders.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Rufinamide in children and adults in routine clinical practice.

Author: JarabaS, SantamarinaE, MiróJ, ToledoM, MolinsA, BurcetJ, BecerraJ L, RaspallM, PicoG, MiravetE, CanoA, FossasP, FernándezS, FalipM

Seizure reduction
Nausea
Vomiting
Weight loss

Rufinamide is well tolerated and effective in reducing the frequency of generalized tonic-clonic, tonic/atonic, and focal seizures in children and adults with severe refractory epilepsies, primarily Lennox-Gastaut Syndrome.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

10.

Safety and retention rate of rufinamide in 300 patients: a single pediatric epilepsy center experience.

Author: Thome-SouzaSigride, KadishNavah E, RamgopalSriram, Sánchez FernándezIván, BerginAnn M, BoltonJeffrey, HariniChellamani, LibensonMark, OlsonHeather, PetersJurriaan, PoduriAnnapurna, RotenbergAlexander, TakeokaMasanori, KothareSanjeev V, KapurKush, BourgeoisBlaise F D, LoddenkemperTobias

Epilepsy treatment

This study evaluated the use of rufinamide in a single pediatric center with a large cohort and long-term follow-up period, providing valuable insights into its use as an add-on therapy in children and adolescents with refractory epilepsy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

The long-term safety of antiepileptic drugs.

Author: GaitatzisAthanasios, SanderJosemir W

Epilepsy treatment
Adverse effects
Neurodevelopmental effects
Teratogenic effects

Antiepileptic drugs (AEDs) are associated with adverse effects that can impact treatment tolerability and success. Physicians should be aware of the late and chronic AEs of AEDs and systematically screen for them.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

Cognitive side-effects of antiepileptic drugs in children.

Author: IjffDominique M, AldenkampAlbert P

Cognitive enhancement
Epilepsy treatment
Attention impairment
Cognitive impairment
Language function impairment
Memory impairment

This article explores the impact of antiepileptic drugs (AEDs) on cognitive function in patients with epilepsy. It highlights the varying cognitive effects of different AEDs, emphasizing the importance of selecting appropriate AEDs to minimize cognitive impairment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

First long-term experience with the orphan drug rufinamide in children with myoclonic-astatic epilepsy (Doose syndrome).

Author: von StülpnagelC, CoppolaG, StrianoP, MüllerA, StaudtM, KlugerG

Myoclonic-astatic epilepsy treatment
Loss of efficacy
Side effects

Rufinamide (RUF) was an effective treatment option for children with myoclonic-astatic epilepsy (MAE), particularly for preventing myoclonic-astatic seizures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Low long-term efficacy and tolerability of add-on rufinamide in patients with Dravet syndrome.

Author: MuellerA, BoorR, CoppolaG, StrianoP, DahlinM, von StuelpnagelC, LotteJ, StaudtM, KlugerG

Seizure aggravation
Side effects

Rufinamide is not effective in treating Dravet syndrome, a rare genetic epilepsy. In a study of 20 patients, only 20% responded to the treatment after 6 months, and only 5% responded after 34 months. Moreover, 30% of patients experienced seizure aggravation, 45% experienced no effect, and 10% experienced side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

15.

[Lennox-Gastaut syndrome--course and treatment].

Author: LundCaroline, BrodtkorbEylert, NakkenKarl O

Clinical presentation
LGS description

Lennox-Gastaut syndrome (LGS) is a severe epileptic encephalopathy that starts in childhood with various seizure types. Children with LGS develop cognitive impairment and a typical EEG pattern. This article describes the clinical presentation of LGS, with a focus on its course in adulthood.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : Norwegian

16.

New drugs for pediatric epilepsy.

Author: Chu-ShoreCatherine J, ThieleElizabeth A

Epilepsy treatment

This article highlights six new antiepileptic medications recently approved or pending approval for use in the United States. For each medication, information is provided regarding its history, mechanism of action, pharmacokinetics, efficacy, tolerability, and unique features relevant for the pediatric population.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Rufinamide in children and adults with Lennox-Gastaut syndrome: first Italian multicenter experience.

Author: CoppolaGiangennaro, GrossoSalvatore, FranzoniEmilio, VeggiottiPierangelo, ZamponiNelia, ParisiPasquale, SpaliceAlberto, HabetswallnerFrancesco, FelsAntonio, CapovillaGiuseppe, VerrottiAlberto, ManganoSalvatore, BalestriAlberto, CuratoloPaolo, PascottoAntonio

Mild side effects
Reduced seizures
Drowsiness
Irritability
Loss of appetite
Vomiting

Rufinamide, an adjunctive therapy, reduced the number of drop attacks and major motor seizures in about 60% of patients with Lennox-Gastaut syndrome.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

18.

Experience with rufinamide in a pediatric population: a single center's experience.

Author: VendrameMartina, LoddenkemperTobias, GootyVasu D, TakeokaMasanori, RotenbergAlexander, BerginAnn M, EksiogluYaman Z, PoduriAnnapurna, DuffyFrank H, LibensonMark, BourgeoisBlaise F, KothareSanjeev V

Generalized seizure treatment
Side effects

Rufinamide is a new antiepileptic drug that is effective in treating various types of seizures, including tonic/atonic and partial seizures. It is well tolerated, with only 13% of patients experiencing side effects that required discontinuation of the drug.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Rufinamide in refractory childhood epileptic encephalopathies other than Lennox-Gastaut syndrome.

Author: CoppolaG, GrossoS, FranzoniE, VeggiottiP, ZamponiN, ParisiP, SpaliceA, HabetswallnerF, FelsA, VerrottiA, D'AnielloA, ManganoS, BalestriA, CuratoloP, PascottoA

Effective drug
Seizure reduction
Drowsiness
Vomiting

Rufenamide was an effective and well-tolerated adjunctive drug for treating refractory childhood-onset epileptic encephalopathies other than Lennox-Gastaut syndrome. It was particularly effective in patients with drop-attacks and (bi)frontal spike-wave discharges.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

20.

[Antiepileptic drugs in North America].

Author: AkiyamaTomoyuki, OtsuboHiroshi

Improved seizure control
Reduced adverse effects

This review compares second-generation antiepileptic drugs (AEDs) and injectable AEDs available in North America and Japan. The second-generation AEDs have improved efficacy and safety profiles compared to older AEDs. Levetiracetam is considered to be the closest to being the ideal AED because of its broad-spectrum activity, favorable pharmacokinetic profile, and safety profile.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : Japanese

21.

Safety and tolerability of rufinamide in children with epilepsy: a pooled analysis of 7 clinical studies.

Author: WhelessJames W, ConryJoan, KraussGregory, MannAllison, LoPrestiAntonia, NarurkarMilind

Safe for children
Headache
Somnolence
Vomiting

Rufinamide showed a favorable safety and tolerability profile in pediatric patients with Lennox-Gastaut syndrome.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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