FDA approves meropenem for infants with abdominal infections
The FDA today approved the antibiotic meropenem for the treatment of abdominal infections in neonates and infants aged younger than 3 months, according to a press release from the NIH.
Previously approved to treat complicated intra-abdominal infections and complicated skin infections in adults and older children, meropenem has been prescribed “off-label” for preterm infants with serious abdominal infections due to a lack of an effective alternative.
In response to a written request from the FDA to evaluate the appropriate dosing and safety of meropenem for complicated intra-abdominal infections in infants, the NIH initiated a study to investigate its use in infants aged younger than 3 months, including premature infants. The FDA based its approval of meropenem on results of the open-label, multicenter, prospective, multiple pharmacokinetic and safety study that included 200 infants (median postnatal age, 21 days; median gestation age, 27.8 weeks).
Based on study results, meropenem was well-tolerated in this cohort of critically ill infants and was not associated with an increased risk for serious side effects. The most commonly reported adverse events included sepsis (6%), seizures (5%), elevated conjugated bilirubin (5%) and hypokalemia (5%). Only two of the serious adverse events were considered to be possibly related to meropenem.
Effectiveness was measurable in 96% of patients, with an overall treatment success rate of 84.4% (95% CI, 78.5%-89.2%).
“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, said in the release. “In addition, we now have dosing guidelines for various age groups of premature infants.”
The FDA-requested labeling changes — including dosing recommendations for the use of meropenem in neonates and infants aged younger than 3 months for complicated intra-abdominal infections — are on the FDA website.