FDA’s research guidance will help take guesswork out of drug dosing in newborns

When we need to give medicine to newborns in our hospital, we often have to guess at the correct dose to give them. That’s a problem: give too little and the medicine might not work; give too much and it might cause harm. Dosing newborn babies with greater precision has been a challenge because it is difficult to conduct studies in this population, many of whom are very small and often critically ill. For researchers trying to determine the appropriate dosing for a medicine for adults, the FDA has clear guidelines on how to give the medicine, collect blood samples, examine the drug level in the blood, apply math to analyze how the level changes over time, and make decisions based on these analyses. But these guidelines don’t necessarily work for studying drugs in full-term and premature babies, who could weigh as little as 1 pound. Not only are newborns smaller, but their organs aren’t yet fully developed, so it may take longer for them to process or excrete medicines compared to older children and adults. It is also harmful to take as many blood samples from a newborn as can be taken from an adult.