Abstract
ObjectiveWe hypothesized (1) that gastrointestinal (GI) and renal adverse events (AE) would occur more often in infants first prescribed ibuprofen before rather than after six months of age and (2) that ibuprofen would be associated with more adverse effects than acetaminophen in infants younger than six months.MethodsWe created two partly overlapping retrospective cohorts of infants aged less than six months when California Medicaid first paid for ibuprofen or acetaminophen between 2004 and 2010. In the first cohort we compared the incidence rate ratio (RR) of GI and renal AE between those infants first prescribed ibuprofen before six months of age with those first prescribed ibuprofen after six months of age. In the second cohort we compared the RR of GI and renal AE between infants younger than six months prescribed ibuprofen (+/-acetaminophen) with those prescribed only acetaminophen.ResultsWe identified 41,669 prescriptions for ibuprofen and 176,991 prescriptions for acetaminophen in 180,333 eligible infants (median age 2.1 months). We did not observe higher RR of any AE in infants first prescribed ibuprofen before rather than after six months of age. Most infants prescribed ibuprofen were also prescribed acetaminophen. Any GI (adjusted (a)RR 1.25, 95% CI 1.13–1.38) and moderate or severe GI AE (aRR 1.24, 95% CI 1.09–1.40) were more common in infants younger than six months who were prescribed ibuprofen versus acetaminophen alone. Severe GI (aRR 0.63, 95% CI 0.27–1.45) and renal AE (aRR 1.84 95% CI 0.66–5.19) were not different between the ibuprofen (+/-acetaminophen) and acetaminophen-only groups.ConclusionsGI and renal AEs were not higher in infants younger than six months who were prescribed ibuprofen compared with those aged six to 12 months. AEs were increased in infants younger than six months who were prescribed ibuprofen compared with infants who were prescribed acetaminophen alone.
Highlights
Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is an effective antipyretic and analgesic in children
adverse events (AE) were increased in infants younger than six months who were prescribed ibuprofen compared with infants who were prescribed acetaminophen alone
In adjusted analysis we found a lower incidence rate of any GI adverse events and a similar incidence rate of severe GI events when ibuprofen was first prescribed before six months of age; see Tables 4 and 5
Summary
A nonsteroidal anti-inflammatory drug (NSAID), is an effective antipyretic and analgesic in children. Ibuprofen use in the United States is widely confined to infants over six months of age because of safety concerns. The primary safety concerns about using ibuprofen in infants younger than six months of age are: adverse gastrointestinal (GI) effects,[5] risk of renal failure (RF),[6,7,8] increased risk of necrotizing fasciitis,[9, 10] and Reye’s Syndrome.[11] These concerns persist despite ibuprofen use in the neonatal intensive care unit[12, 13] and reassuring data and clinical experience between six and 24 months of age.[14] There is a dearth of information demonstrating harm from using ibuprofen in infants under six months of age and little commercial incentive to gather such data. In sharp contrast the British National Formulary provides specific dosing guidance for infants aged 1 to 3 months.[16]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
