Detecting Potential Adverse Drug Reactions of Preschool ADHD Treatment Using Health Consumer-Generated Content

Post-marketing surveillance of drugs is important because many adverse drug reactions (ADRs) cannot be detected in the pre-marketing clinical trials due to their limited scale and duration. This is especially true for pediatric patients who are often excluded from clinical trials out of ethical considerations. As a result, drug safety and efficacy data on children are largely missing, and pediatricians are compelled to prescribe in moderation based on adult data. Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders that affect children. Six million American children are diagnosed with ADHD, among whom one-third are toddlers and preschoolers aged 2-5 years. The medical community and the public are vigilant of the potential adverse drug reactions among the preschooler population due to their young age, although very few studies are available. At present, post-marketing pharmacovigilance relies heavily on spontaneous reporting systems, electronic health records (EHR), and other relevant databases. These approaches are robust but not without limitations. For instance, access to these datasets is limited to approved personnel, and secondary use of the data for pharmacovigilance research is usually lagged. Most data input to spontaneous reporting systems is from professionals, since patients may not be aware of or have the capacity to navigate those systems. Recently, researchers have started paying attention to health consumer-generated content from social media platforms for post-marketing surveillance due to their ease of use to consumers and abundance in data volume. In this study, we mined the signals of associations between drugs and adverse drug reactions for preschool-aged children with ADHD using health consumers-generated content and examined their clinical implications. We identified four drug-ADR associations supported by clinical trials or post-marketing evidence and three known but relatively rare associations that require further studies.