Antibiotic Approved for Infant Abdominal Infections
WASHINGTON, June 1 (UPI) — The FDA has approved the antibiotic meropenem for treating intestinal perforation, or leakage, in children less than three months old, offering doctors guidelines for using the drug with preterm infants.
The National Institutes of Health funded two studies to explicitly use meropenem with infants, which previously had been approved only for intra-abdominal and skin infections in older children and adults.
“This study shows that meropenem is appropriate for treating complicated intra-abdominal infections in very young infants,” said Anne Zajicek, M.D., Pharm.D., chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a press release. “In addition, we now have dosing guidelines for various age groups of premature infants.”
The study included 200 infants with a median age of 21 days and who were born between four and zero months early. Meropenem was used in patients with bacterial infections as a result of intestinal perforation.
The study was meant to establish guidelines for use rather than efficacy because doctors have been using it with infants already for several years based on studies and guidelines for adults and older children. Before approving the guidelines, the FDA also conducted a separate study using data gathered on 5,566 patients between 1997 and 2010. It showed that adverse effects from meropenem were equal to or less than the similarly used treatments imipenem and cilastatin.
The FDA approval is published in The Federal Register.
