PTN’s Clindamycin research informs FDA label change

RX Drugs The U.S. Food and Drug Administration (FDA) has updated the prescribing information, or drug label, of Clindamycin, based on data provided by the Pediatric Trials Network (PTN). The updated label now includes dosing guidelines for children with obesity.

“Sometimes in children with obesity, the way the body absorbs and processes drugs is different than in other children because of the way their weight is distributed throughout their bodies. This means that it is important to study drugs in children with and without obesity, to make sure we are prescribing doses that are safe and effective for all children,” said Dr. Kanecia Zimmerman, from the PTN Steering Committee.

This study, which completed in 2016, determined the PK of intravenous and oral Clindamycin in pediatric patients with obesity and characterized the safety profile of Clindamycin in children and adolescents with obesity.

“Updating labels for commonly used pediatric drugs, such as Clindamycin, is an excellent way to ensure that children with obesity receive the best possible pharmacologic care. While many drugs remain to be studied in this population, seeing this updated Clindamycin label should certainly be encouraging for all PTN members and sites involved in these studies,” said Dr. Christoph Hornik, from the Duke Department of Pediatrics and one of the PTN investigators involved in the study.

Stay data may be viewed on NICHD’s Data and Specimen Hub (DASH).



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