The antibiotic meropenem was approved by the U. S. Food and Drug Administration for treating abdominal infections in children less than 3 months of age. The approval came after a study by a National Institutes of Health research network evaluated the drug in treating children in this age group, according to a news release. Among preterm infants, intestinal perforation or leakage — which is part of complicated intra-abdominal infection — may be life threatening.
“This study shows that meropenem is appropriate for treating complicated intra-abdominal infections in very young infants,” Anne Zajicek, MD, PharmD, chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study, said in the release. “In addition, we now have dosing guidelines for various age groups of premature infants.”
The study was undertaken under the terms of the Best Pharmaceuticals for Children Act, which directed NIH to conduct studies on drugs used in children but not previously tested in children or in specific pediatric age groups. Under the act, NICHD works with FDA to identify drugs not tested in children to determine if they are appropriate for use in children, according to the release.
The NICHD commissioned the study to investigate meropenem use in 200 infants under 3 months of age, including premature infants. Researchers examined how the drug was absorbed and distributed throughout the body, and used that information to develop dosing recommendations for different age groups of infants. In addition, the study evaluated side effects. Based on this study, treatment of infants with meropenem was safe and was not associated with increased risk for serious side effects.
Meropenem is a broad spectrum antibiotic that had been approved to treat complicated intra-abdominal infections and complicated skin infections in adults and older children, and for treating children 3 months of age and older with bacterial meningitis.