How drug safety monitoring works when paediatric trials are small
Rare adverse events rarely show up in trials of a few hundred children. Post-marketing surveillance has to do the heavy lifting.
Pharmacovigilance, label changes and safety signals in children’s medicines.
Rare adverse events rarely show up in trials of a few hundred children. Post-marketing surveillance has to do the heavy lifting.
Safety
A painkiller given to children for decades turned out to be dangerous for a genetically identifiable minority. The response remains a model for pharmacogenomic safety.
Safety
A medicine given to a child can affect growth, development and fertility years after the last dose. Trials end long before those effects would show.
Safety
Weight-based dosing, liquid formulations and adult-sized products combine to make children unusually vulnerable to medication errors.
Safety
The label is where paediatric evidence becomes usable at the bedside. US and EU rules now require results to reach it, even when the studies fail.
Safety
Second-generation antipsychotics are increasingly prescribed to children and adolescents. Their effects on weight and metabolism appear to be greater than in adults.