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Antibiotic Gets FDA Nod for Treatment of Infant Abdominal Infections

NIH-funded study evaluated meropenem in children under 3 months of age

The antibiotic meropenem has been approved by the FDA for treating abdominal infections in children less than 3 months of age. The approval came after a study by a National Institutes of Health (NIH) research network evaluated the drug in treating children in this age group.

The May 28 issue of the Federal Register described the study, which supported the approval of meropenem for “complicated intra-abdominal infections” in children under 3 months of age. Among preterm infants, intestinal perforation or leakage –– a part of complicated intra-abdominal infections –– may be life- threatening.

The study was conducted under the terms of the Best Pharmaceuticals for Children Act (BPCA), which directed the NIH to conduct studies on drugs used in children but not previously tested in children or in specific pediatric age groups.

Meropenem is a broad-spectrum antibiotic that is effective against a wide variety of bacteria, according to the NIH. The drug has 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.

During the last several years, physicians have begun prescribing meropenem for preterm infants with serious abdominal infections –– an unapproved use. The NIH study was undertaken in response to a written request from the FDA to evaluate the dosing and safety of meropenem in the treatment of complicated intra-abdominal infections in infants under 3 months of age.

“This study shows that meropenem is appropriate for treating complicated intra-abdominal infections in very young infants. In addition, we now have dosing guidelines for various age groups of premature infants,” said Anne Zajicek, MD, PharmD, chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study.

Zajicek explained that physicians often need to extrapolate from studies of adults when prescribing for pediatric patients because many drugs have never been tested specifically for use in children. However, because of their smaller size, differences in metabolism, and other physical differences from adults, children may show different responses to many drugs. Under the BPCA, the NICHD works with the FDA to identify drugs not tested in children to determine whether they are appropriate for use in children.

Source: NIH; May 29, 2015.

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