Pyridoxine and Magnesium Administration-Induced Hyperactivity in Two Children With Autism Spectrum Disorder: Case Reports From a Clinical Trial.

PURPOSE: Pyridoxine hydrochloride and magnesium sulfate (pyridoxine-Mg) have been used for the management of autism spectrum disorder (ASD). We present a case report of 2 children with ASD who were administered pyridoxine-Mg for 2 months.

METHODS

The Childhood Autism Rating Scale, Second Edition, was used to confirm the adverse reaction. The Naranjo Adverse Drug Reaction Probability Scale was used to assess causality.

RESULTS

Children were reported by their parents as being hyperactive. Evaluation by the psychologist using the Childhood Autism Rating Scale, Second Edition, also confirmed the reaction. According to the Naranjo scale, hyperactivity had a possible and probable association with pyridoxine-Mg for child 1 and 2, respectively.

IMPLICATIONS: A probable to possible association exists between hyperactivity and pyridoxine-Mg. Clinical Trial Registry-India identifier: CTRI/2019/07/020102.