Drug side effects across pediatric development stages identified

Side effects from pediatric drug treatment are responsible for nearly 10 percent of childhood hospitalizations, with nearly half of those being life-threatening. Despite the need to know more about these drugs and the adverse events they can have on children, little evidence is currently available.

Clinical trials remain the gold standard for identifying adverse drug events (ADEs) for adults, but these have both ethical and methodological concerns for the pediatric population. The rapidly changing biologic and physiologic developments only enhance the challenges of understanding the potential impacts of different drug treatments at various stages of childhood.

Researchers at the Columbia University Irving Medical Center developed a novel algorithm that identified nearly 20,000 ADEs signals (information on a new or known side effect that may be caused by a particular drug) across the seven pediatric development stages and made them freely available. This process is strengthened by a novel approach that allows neighboring development stages to enhance the signal detection power, which helps it overcome limited data within individual stages.

This use of predictive modeling on real-world data can help address a critical gap in healthcare research around the understudied pediatric community.

DBMI associate professor Nicholas Tatonetti and Nick Giangreco, a recent Systems Biology PhD graduate at Columbia University, shared these findings in the study A database of pediatric drug effects to evaluate ontogenic mechanisms from child growth and development, which was recently published in Med.

“For many reasons, children have historically not been included in clinical trials,” Tatonetti said. “There are many ethical issues around including children in trials, and there are several limitations when children are included that make it difficult to assess the effectiveness and safety of drugs.”

Because of these factors, few drugs are specifically approved for use in children, though once drugs are approved for adults, physicians can prescribe them “off-label” to children.

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