Safety and Tolerability of Antiepileptic Drug Treatment in Children with Epilepsy (original) (raw)
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Antiepileptic drug-related adverse reactions and factors influencing these reactions
Iranian journal of child neurology, 2013
According to the basic role of drug side effects in selection of an appropriate drug, patient compliance and the quality of life in epileptic patients, and forasmuch as new drugs with unknown side effect have been introduced, necessity of this research is explained. This study was conducted to evaluate the incidence and clinical characteristics of anti epileptic drug (AED) related adverse reactions in children. In this descriptive study, children less than 14 years old with AED side effects referred to the Children's Medical Center and Mofid Childeren's Hospital (Tehran, Iran) were evaluated during 2010-2012. The informations were: sex, age, incriminating drug, type of drug side effect, incubation period, history of drug usage, and patient and family allergy history. Exclusive criterions were age more than 14 years old and reactions due to reasons other than AEDs. A total of 70 patients with AED reaction were enrolled in this study. They included 26 (37%) females and 44 (63%...
Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs
International Journal of Environmental Research and Public Health
Objective: To investigate the occurrence of adverse effects of antiepileptic drugs (AEDs) in pediatric epileptic patients on mono- or polytherapy. Method: We evaluated eighty consecutive patients that met the following inclusion criteria: aged ≤18 years; diagnosed with epilepsy for at least one year; a stable dose of AED for at least three months; verbal consent to participation in the study. Patients were asked if they had experienced any adverse drug reaction (ADR) related to the AED. Afterward, regardless of the answer, they were interviewed based on a detailed semi-structured questionnaire about the presence of ADRs associated with the AED. The data were analyzed regarding the use of monotherapy or polytherapy. Results: Ninety-seven percent of the patients reported having experienced ADRs related to AEDs. The greatest number of seizures affected the group of patients treated with monotherapy (both at baseline and at followup), but the greatest number of ADRs were observed among ...
A prospective study of adverse drug reactions to antiepileptic drugs in children
BMJ open, 2015
To prospectively determine the nature and rate of adverse drug reactions (ADRs) in children on antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour. A single centre prospective observational study. Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit. Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes. 180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue ...
Adverse Drug Reactions of Antiepileptic Drugs
Atlas of Epilepsies, 2010
Background: Adverse drug reactions (ADRs) due to antiepileptic drugs (AEDs) in children contribute to poorer patient outcomes. However, reliable data ragarding such ADRs is not available. Objectives: Thus, the aim of the present study was to determine the incidence and patterns of ADRs of antiepileptic drugs in children aged 2-17 years presenting to a tertiary care teaching hospital. Methods: An observational study was conducted in the Department of Pediatrics, Kalawati Saran Children's Hospital for a period of one year. Two hundred consecutive eligible patients (aged 2-17 yrs with epilepsy on AED) with consenting parents were enrolled. ADRs were noted using Paediatric Epilepsy Side Effect Questionnaire (PESQ) at clinic visits and any other ADRs reported by parents were also recorded. Causality, severity and avoidability assessments were done. Results: The mean age was 10.5 ± 3.6 years. A total of 139 ADRs occurred in 97 patients. One hundred and nine ADRs were reported by use of PESQ, in addition, 30 ADRs were reported by parents. Poor school result (33.8%) was the commonest ADR. Valproate (61.9%) was the main drug causing ADRs. Valproate, when used in polytherapy, was associated with more number of children experiencing ADRs (72.2%). The most common add on drug was clobazam (42.3%). Children with poorly controlled epilepsy were associated with more ADRs. Causality assessment revealed that 91.3% of the ADRs were probable. Most (94.9%) ADRs were of 'mild' category and 95.7% were probably preventable. Treatment was discontinued only in 6 patients of phenytoin toxicity. Conclusion: Cognitive and neurological problems were the most common ADRs seen in children with epilepsy. Polytherapy significantly increases the likelihood of ADRs in children.
Adverse Drug Reactions of Anti-Epileptic Drugs in Children with Epilepsy: A Cross-Sectional Study
Current Drug Safety, 2019
Background: Adverse drug reactions (ADRs) due to antiepileptic drugs (AEDs) in children contribute to poorer patient outcomes. However, reliable data ragarding such ADRs is not available. Objectives: Thus, the aim of the present study was to determine the incidence and patterns of ADRs of antiepileptic drugs in children aged 2-17 years presenting to a tertiary care teaching hospital. Methods: An observational study was conducted in the Department of Pediatrics, Kalawati Saran Children's Hospital for a period of one year. Two hundred consecutive eligible patients (aged 2-17 yrs with epilepsy on AED) with consenting parents were enrolled. ADRs were noted using Paediatric Epilepsy Side Effect Questionnaire (PESQ) at clinic visits and any other ADRs reported by parents were also recorded. Causality, severity and avoidability assessments were done. Results: The mean age was 10.5 ± 3.6 years. A total of 139 ADRs occurred in 97 patients. One hundred and nine ADRs were reported by use of PESQ, in addition, 30 ADRs were reported by parents. Poor school result (33.8%) was the commonest ADR. Valproate (61.9%) was the main drug causing ADRs. Valproate, when used in polytherapy, was associated with more number of children experiencing ADRs (72.2%). The most common add on drug was clobazam (42.3%). Children with poorly controlled epilepsy were associated with more ADRs. Causality assessment revealed that 91.3% of the ADRs were probable. Most (94.9%) ADRs were of 'mild' category and 95.7% were probably preventable. Treatment was discontinued only in 6 patients of phenytoin toxicity. Conclusion: Cognitive and neurological problems were the most common ADRs seen in children with epilepsy. Polytherapy significantly increases the likelihood of ADRs in children.
Safety of antiepileptic drugs in children and young people: A prospective cohort study
Seizure, 2018
This study aims to describe the incidence of adverse drug reactions (ADRs) in children receiving antiepileptic drugs (AEDs) and compare ADRs to the individual drugs when given as monotherapy. Paediatric patients (≤18 years old) were enrolled for this prospective observational study over a 6-month period, between September 2015 and March 2016. Adverse reactions to antiepileptic drugs (AEDs) were elicited at the time of enrolment and after 3 months using the Paediatric Epilepsy Side Effects Questionnaire. A total of 1139 suspected ADRs were reported in 124 participants. Eighteen different AEDs were prescribed. Sixty-six children (53%) were receiving AED monotherapy at the time of recruitment; 34/66 (52%) of whom received new generation AEDs. Levetiracetam was the most frequently prescribed AED (62/124, 50%). When only children receiving AED monotherapy were considered, fatigue, drowsiness, weight gain, dizziness were less likely with levetiracetam (p < .01). Slow thinking and decre...
Using antiepileptic drugs in children : recent developments and recommendations
2017
Epilepsy is one of the most common neurological disorders, with approximately 45 per 100,000 children developing new-onset epilepsy every year. Children are a vulnerable population with unique health needs and a correct diagnosis and thus correct treatment of epilepsy in children, particularly a diagnosis of early onset epilepsy, is important in order to ensure better quality of life, neurodevelopmental outcomes, cognition, education, improved level of function and future employment. Therapy with antiepileptic drugs (AEDs) aims to minimize the frequency of epileptic seizures with minimal side effects. The first generation AEDs (such as phenytoin, carbamazepine and valproic acid) are still widely used, although they are associated with serious side effects and pharmacokinetic problems (narrow therapeutic indices, nonlinear kinetics, and drug-drug interactions due to enzyme inhibition and enzyme induction properties). The novel AEDs (such as lamotrigine, levetiracetam, rufinamide, and...
Antiepileptic Drug Treatment in Children with Epilepsy
CNS drugs, 2015
Most children with new-onset epilepsy achieve seizure freedom with appropriate antiepileptic drugs (AEDs). However, nearly 20 % will continue to have seizures despite AEDs, as either monotherapy or in combination. Despite the growing market of new molecules over the last 20 years, the proportion of drug-resistant epilepsies has not changed. In this review, we report the evidence of efficacy and safety based on phase III randomized controlled clinical trials (RCTs) of AEDs currently used in the paediatric population. We conducted a literature search using the PubMed database and the Cochrane Database of Systematic Reviews. We also analysed the RCTs of newer AEDs whose efficacy in adolescents and adults might suggest possible use in children. Most of the phase III trials on AEDs in children have major methodological limitations that considerably limit meaningful conclusions about comparative efficacy between old and new molecules. Since the efficacy of new drugs has only been reported...
Antiepileptic Drug-Induced Worsening of Seizures in Children
Epilepsia, 1998
Antiepileptic drugs (AEDs) may aggravate preexisting seizures and trigger new seizure types. However, the extent and mechanisms of this problem are unclear, for several reasons. AED trials are not designed to detect worsening of seizures, severe childhood epilepsies may fluctuate in severity, and worsening of seizures may be over-hastily ascribed to the introduction of a new AED. Moreover, the seizure and the epilepsy type may have been incorrectly diagnosed. The problem is identification of true aggravation of epilepsy in the absence of overdosage or toxicity. This is a common and clinically important problem that concerns both established and newer AEDs, but the biologic mechanisms involved are unknown. An increase in seizure frequency due to overdosage has been reported with phenytoin but is rare with other AEDs. Paradoxical reaction has been reported with carbamazepine (CBZ), benzodiazepines, and vigabatrin (VGB). Exacerbation of seizures may also occur during AED-induced encephalopathy or hepatopathy. An inappropriate choice of the AED (i.e., a purely pharmacodynamic mechanism) can induce worsening when CBZ or VGB is used in absence and myoclonic seizures. Further research should determine whether seizure exacerbation is associated with the type of epilepsy or with the type of EEG abnormality. Recent evidence indicates that lamotrigine i8 inappropriate in severe myoclonic epilepsy. Some childhood epileptic encephalopathies have been affected by certain seizure-worsening mechanisms. Whether this is due to a predisposition in specific syndromes or to an increased risk for adverse effects in patients undergoing multiple AED manipulations is unclear. Furthermore, some syndromes are not the sum of accompanying seizure types but have unique neurobiology.
Seizure, 2014
Epilepsy is the most common chronic neurologic disorder that requires long-term medication in children. Its prevalence has been estimated at 0.5-1% in children. 1,2 Prior to 1993, the choice of AEDs was limited to old antiepileptic drugs (AEDs) (phenobarbital, primidone, phenytoin, carbamazepine, valproate and ethosuximide). Among them, valproate, carbamazepine and phenobarbital are effective and more widely used medications for the treatment of many types of epilepsy. 3 Since 1993, 11 new AEDs (felbamate, oxcarbazepine, gabapentin, lamotrigine, topiramate, levetiracetam, tiagabine, vigabatrin,pregabalin, rufinamide, zonisamide, and lacosamide) have been introduced to the market. Because of the lack of data on the efficacy and safety of the new AEDs, their applications depend on the clinicians' own experiences. Levetiracetam and oxcarbazepine are the new generation AEDs, that are increasingly used as monotherapy as well as add-on therapy in children. 4,5 However, treatment failure due to lack of seizure control or intolerable adverse effects remains the major consequences in children suffering from epilepsy. The pharmacokinetics of AEDs in pediatric population differ considerably from those of adults. 6 Although it has been suggested that the efficacy of AEDs in adults could be used to predict the efficacy of AEDs in the pediatric population, 7 effectiveness of old and new AEDs in everyday child neurology practice has not been