Effectiveness and adverse drug reactions between generic and original risperidone solution in patients with autism spectrum disorder
Keywords:
adverse drug reaction, autism spectrum disorder, effectiveness, risperidone solutionAbstract
Objectives: To evaluate and compare the effectiveness and adverse drug reactions (ADRs) between generic and original risperidone solution in patients with autism spectrum disorder (ASD).
Methods: This study was an open-label randomized controlled trial. Sixty ASD patients aged 3-12 who first prescribed antipsychotic drug were randomly assigned to generic or original risperidone solution. The effectiveness of treatment were assessed by aberrant behavior checklist- community (ABC-C) at baseline, week 4, week 8, and week 24. ADRs were measured at week 4, week 8, and week 24.
Results: At week 4, the mean score of the irritability subscale in ABC-C showed a significant decrease for both groups (14.7 + 10.7 scores for the generic group and 16.5 + 8.6 scores for the original group). The average doses and frequented ADRs, such as increased appetite, dry mouth, constipation, and drooling, were not statistically different between these two groups. However, the original risperidone solution had a more significant rate of somnolence.
Conclusion: There were no differences in the effectiveness and adverse drug reactions between generic and original risperidone solution in patients with autism spectrum disorder (ASD), except for more somnolence from the original one.
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