Study: Ibuprofen Safe for Infants Under 6 Months
SACRAMENTO, Calif. – Ibuprofen is as safe for children under 6 months old as it is for those over that age, according to a recently published study on PLOS ONE by Dr. Paul Walsh, the medical director of Sutter Medical Center, Sacramento’s Pediatric Emergency Department.
The U.S. Food and Drug Administration does not allow ibuprofen to be sold over-the-counter for parents to treat their sick children under the age of 6 months. This has led to some pediatricians and family physicians to avoid ibuprofen in these infants. While there is significant information on ibuprofen’s safety for children over 6 months old, there was much less research on its use for infants under 6 months. Some community physicians and most hospital-based pediatric emergency departments as well as neonatal and pediatric intensive care units traditionally have used ibuprofen in these younger infants, said Dr. Walsh, the principal investigator of the study.
“While fever of itself is unlikely to be harmful, it can lead to fussiness and feeding refusal. This can lead to dehydration and an ill appearance,” Dr. Walsh said. “In this scenario, if acetaminophen alone isn’t bringing down the fever, an appropriate dose of Ibuprofen should be prescribed to reduce the fever, allow re-establishment of feeding and, in some cases, prevent unnecessary lab testing.”
The study used data from the California Department of Public Health on 180,000 infants 6 months or younger who received prescriptions for medicine to reduce fever. It looked for adverse events from the primary safety concerns about using ibuprofen in infants younger than 6 months of age, which include gastrointestinal (GI) effects, risk of renal failure and Reye’s Syndrome. The study concluded that ibuprofen is not inherently associated with more side effects in children younger than 6 months compared with those older than 6 months. However, compared to acetaminophen alone, ibuprofen is associated with more adverse GI effects in infants younger than 6 months just as it is with children over 6 months.
“What we found is that using ibuprofen for infants may cause a slight increase in some GI issues – an upset tummy (1.7 versus 1.5 events per 10,000 infant days exposure to ibuprofen versus acetaminophen alone) – but in many cases this trade-off will be well worthwhile,” Dr. Walsh said. “My hope is that our data will allow doctors who care for children to be more comfortable in prescribing ibuprofen to those under the age of 6 months.”
Assisting Dr. Walsh in analyzing the data for the study were Stephen J. Rothenberg, an epidemiologist with the National Institute of Public Health in Mexico, and Heejung Bang, a biostatistician with the UC Davis Department of Public Health Services.
For the entire study, go to http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0199493.