December 1, 2023

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Scientists founds more side effects of pediatric drugs by new algorithm

Scientists founds more side effects of pediatric drugs by new algorithm


Scientists founds more side effects of pediatric drugs by new algorithm.

A new study identifies drug side effects throughout pediatric developmental stages.

Pediatric drug side effects account for approximately 10% of pediatric hospital admissions, and nearly 50% of these side effects are life-threatening.

Although more needs to be learned about these drugs and their negative effects on children, there is currently little evidence.


Scientists founds more side effects of pediatric drugs by new algorithm.



Although clinical trials remain the gold standard for detecting adverse drug events (ADEs) in adults, they raise ethical and methodological concerns when used in the pediatric population.

Understand the possible effects of various drug treatments at different times in childhood, issues that are clearly exacerbated by rapidly changing biological and physiological development.


Researchers at Columbia University Irving Medical Center have created a novel algorithm that identifies nearly 20,000 ADE signals (information about new or known side effects that may be brought about by a particular drug) across seven stages of pediatric development, and make them freely accessible.

This process is aided by a new approach that allows adjacent development stages to enhance signal detection capabilities, allowing it to overcome data limitations within a single stage.


This use of predictive models on real-world data may help address a major hole in healthcare research on understudied pediatric populations.


DBMI Associate Professor Nicholas Tatonetti and Columbia University’s systems biology PhD graduate Nick Giangreco recently published their findings in the journal Medicine.


“Children have historically not been included in clinical trials for a number of reasons,” Tatonetti said. “There are many ethical issues surrounding the inclusion of children in trials, and there are several limitations when children are included in trials that make it difficult to assess the efficacy and safety of drugs. becomes difficult.”


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


He added: “With no drugs being studied and approved directly in children, physicians must rely on adult guidelines. By its very nature, treating children as simple little adults is often an incorrect assumption. This study attempts to systematically elucidate what the potential side effects are when the drug is used off-label in children.”


This study goes beyond simply distinguishing side effects in children from those in adults. It focuses on ADEs at seven developmental stages, from term neonates through late adolescence, and it does so by sharing information about adjacent developmental stages.

For example, infants and toddlers develop close enough to share more characteristics than infants and children in early or late adolescence.


“Previously, children were basically grouped,” Tatonetti said. “There were only a handful of studies that looked at children only, and they basically grouped people 18 and under or 21 and under. The innovation here is to use what’s known developmental stages and our newly introduced DGAMs (disproportionate generalized additive models) to increase the power and enable this analysis.”


These signals are not validated and are primarily intended for researchers.

Parents should consult their pediatrician about specific drug side effects. Giangreco, now a quantitative translational scientist at Regeneron, said the model identified one of several side effects.


He said: “We confirmed an issue with the FDA that montelukast, an asthma drug, was found to cause psychiatric side effects. We also saw this in our database, But we were able to identify certain stages of development where the risk is more pronounced, particularly the second year of life.”


The study also integrated the expression data of paediatric enzymes and found that pharmacogenes with dynamic paediatric expression were associated with paediatric ADE.


“This is a biology-inspired modeling strategy,” Giangreco said. “We developed our modeling strategy using what we knew about biological processes that occurred in childhood. These safety signals came from this prior knowledge of what was going on. Our data-driven approach really tried to capture what we thought was happening in important biological and physiological dynamics that occur during childhood and use this to differentiate observations across developmental stages.”


The model was used in the FDA Adverse Event Reporting System (FAERS) database of 264,453 pediatric reports.

The output of the study is available through KidSIDES, a free, publicly available database of pediatric drug safety signals for use by the research community, and the Pediatric Drug Safety Portal (PDSportal), which will facilitate access to drug safety signals throughout the growth and development of children Evaluate.


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Scientists founds more side effects of pediatric drugs by new algorithm.

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