U.S. Food and Drug Administration updates label on children’s seizure medication after UNC, Duke study provides pharmacokinetic, dosing data

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Brittany Jennings
February 18, 2022

A Pediatric Trials Network pharmacokinetics study led by researchers at the UNC Eshelman School of Pharmacy and Duke University recently contributed to a medication label change for the drug diazepam, commonly used to treat seizures in children.

This research effort, Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status Epilepticus, contributed pharmacokinetic and dosing data for the intravenous administration of diazepam, a benzodiazepine typically used in children for the management of status epilepticus and severe recurrent seizures.

UNC Eshelman School of Pharmacy’s Daniel Gonzalez, Pharm.D., Ph.D., associate professor in the Division of Pharmacotherapy and Experimental Therapeutics, helped lead the effort.

“These seizure episodes are medical emergencies and can result in long-term adverse consequences and even mortality in children, so diazepam is key in preventing these severe episodes,” Gonzalez said. “However, prior to the study, there was limited data characterizing its disposition in pediatric patients. Our goal was to better equip health care professionals with proper dosing data for their young patients.”

Pharmacokinetic and dosing data for the usage of diazepam in children 3 months of age up to 17 years of age has now been incorporated into the FDA drug label because of data analyzed in the study.

This isn’t the first time Gonzalez has helped improve medication labels for children. During his first year on faculty, he worked to support a Pediatric Trials Network study that led to a label change for the drug clindamycin. The label change included pharmacokinetic data for children with obesity.

“Pediatric patients undergo age-dependent changes that can alter the relationships between a medication’s dose and exposure, and between the exposure and response. We can optimize medication dosing to ensure safe and effective use in pediatric patients by characterizing these relationships.” Gonzalez said.

Additional researchers on the Pediatric Trials Network study include: Lawrence C Ku, Christoph P Hornik, Ryan J Beechinor, James M Chamberlain, Jeffrey T Guptill, Barrie Harper, Edmund V Capparelli, Karen Martz, Ravinder Anand, and Michael Cohen-Wolkowiez.