A study pioneered by a Sutter Sacramento doctor has determined Ibuprofen is safe for children under 6 months old.
Ibuprofen is primarily used on infants to treat fever, but children 6 months old or younger need a prescription to be treated with ibuprofen. The federal Food and Drug Administration does not allow the drug to be sold over-the-counter to treat infants.
The study, published by PLOS One and approved by the California Committee for Protection of Human Subjects and the California Department of Health Care Services, aimed to determine whether these patients had developed the harmful side effects of Ibuprofen thought to pose a greater risk to infants.
Side effects of concern include gastrointestinal effects, ulcers, kidney failure and a rare condition known as Reye’s syndrome.
“There really was no difference in safety before and after 6 months,” said Dr. Paul Walsh, the medical director of Sutter Medical Center and a lead researcher on the study. “The other concern is kidney damage and … we found no difference there either.”
The study looked at the medical records of more than 180,000 infants on Medi-Cal who had been prescribed the drug. Medi-Cal keeps records on the Ibuprofen it pays for, Walsh explained.
“The same child could also have records of any visits they go to their doctor for and so we took a look at the records for every baby who got a prescription for Ibuprofen and filled it ... and then looked to see if they developed the side effects that people worry about,” he said.
Researchers received medical data on the approximately 180,000 infants from the California Department of Public Health after applying for access to the records.
Doctors can use a combination of ibuprofen and either acetaminophen or Tylenol to treat fevers. Walsh recognized that a child is at a greater risk for side effects with two drugs, but even then the difference in reported side effects with two drugs compared to one is minimal.
Although there was some grant support for a portion of the study, funding was provided primarily by Walsh himself. He refers to the work as “a labor of love.”
“Sutter … lets me do this kind of work because it recognizes the benefit to their patients and in truth, it benefits everybody else as well,” Walsh said.
And local providers do use ibuprofen to treat infants.
“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,” reports a Sutter press release.
Walsh recognized there is minimal motivation to conduct a study like this.
“The drug companies have no great incentive to do this kind of work because … ibuprofen is very cheap,” Walsh said. “The only way this kind of work is going to happen is if not-for-profit people or public agencies do it.”
Although the study deemed ibuprofen safe for infant use, it will be challenging to remove the prescription barrier in place because the study analyzed only patients who had used the drug with a prescription, Walsh explained.
Additionally, there is a high cost associated with an FDA approval process to change drug administration recommendations.