Adel Mahmoud, Sadia Tabassum, Shoaa Al Enazi, Nahed Lubbad, Ali Al Wadei, Ali Al Otaibi, Lamya Jad and Ruba Benini. Amelioration of Levetiracetam- induced behavioral side effects by Pyridoxine-Randomized double blinded controlled study. Article in Press: Pediatric Neurology.
Levetiracetam is a relatively new generation antiseizure drug approved for the treatment of focal and generalized seizures. Despite its favorable side effect profile and minimal drug-drug interactions, neuropsychiatric side effects are reported in up to 13% of children. A few case series have suggested that supplementation of pyridoxine may mitigate these side effects, but controlled trials are lacking. To address this issue, a randomized interventional study was carried out in a pediatric tertiary hospital to qualify and quantify the potential beneficial effect of pyridoxine in attenuating the neuropsychiatric side effects of Levetiracetam in children.
A total of 105 children with epilepsy on levetiracetam (as a monotherapy or an adjunct) who showed behavioral symptoms coinciding with the start of levetiracetam, were included. Patients randomly and blindly received either a therapeutic (pyridoxine group, 46/105, 44%) or a homeopathic dose of pyridoxine (placebo, 59/105, 56%). A 30-item behavioral checklist was used to qualify and quantify the behavioral side effects at baseline and at different time points following initiation of treatment.
Both Placebo and pyridoxine groups experienced a statistical reduction in behavioral scores as compared to baseline. Our study indicated that although there was a placebo effect, the improvement in neuropsychiatric symptoms was more prominent in children who received therapeutic doses of pyridoxine.
This data provides clinicians with pertinent evidence-based information that suggests that a trial of pyridoxine in patients who experience behavioral side effects due to the use of levetiracetam may avoid unnecessary change of antiseizure medications.
• Epilepsy is a common neurological disorder in children in pediatrics worldwide.
• Levetiracetam is an antiseizure drug that has broad spectrum of action with good efficacy, low side effect profile and minimal drug-drug interactions.
• Behavioral side effects are the commonest with the use of levetiracetam.
• Pyridoxine is claimed to ameliorate behavioral side effects due to levetiracetam.
• This prospective randomized controlled trial provides evidence for the efficacy of pyridoxine in mitigating the behavioral side effects of levetiracetam.
• No adverse side effects were reported with pyridoxine use in the recommended doses.