Safety of ibuprofen in infants younger than six months: A retrospective cohort study

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.

A randomized controlled trial of a combination of antiviral and nonsteroidal anti-inflammatory treatment in a bovine model of respiratory syncytial virus infection

“…[16,17] Ibuprofen is an NSAID that is widely used and generally safe in pediatrics. [18][19][20] Although rarely used in agriculture, where long-acting parenteral agents are preferred, 10-day courses of oral ibuprofen appear reasonably well-tolerated in pre-ruminant calves, although abomasal ulcers and interstitial nephritis have been reported. [21] We have previously shown improved clinical score but also increased viral shedding in bovine calves when ibuprofen rather than placebo was initiated on the day following experimental bovine RSV infection.…”

Comparison of Acetaminophen (Paracetamol) With Ibuprofen for Treatment of Fever or Pain in Children Younger Than 2 Years

“…Of 3933 records identified, 3633 were excluded following title and abstract screening, 276 were excluded following full-text screening, and 4 were ongoing studies. Thus, 19 studies (20 publications 12 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 ) were included ( Figure 1 ).…”

“…Of these, 2 reported fever outcomes, 42 , 43 0 reported pain outcomes, and 8 reported safety outcomes. 12 , 41 , 42 , 43 , 44 , 45 , 46 , 47 Data from 1 study 45 could not be included in the quantitative synthesis. Overall, 6 of 8 nonrandomized studies 12 , 41 , 44 , 45 , 46 , 47 had author adjustment for potential confounding, but only the outcomes of asthma and/or wheeze were extractable; all other extracted effect estimates were unadjusted.…”

Valid P -Values Behave Exactly as They Should: Some Misleading Criticisms of P -Values and Their Resolution With S -Values

“…Concepts will be illustrated with a cohort study which compared adverse event rates among infants receiving ibuprofen (Advil™, Motrin™), alone or in addition to other drugs, to rates among those receiving only acetaminophen (paracetamol, Tylenol™) (Walsh et al 2018). A highlighted result for renal (kidney) adverse events was an adjusted estimated rate ratio (RR) of 1.84 with 95% confidence limits of 0.66, 5.19, which correspond to an event-rate increase of 84% for ibuprofen compared to acetaminophen alone, an interval ranging from a 34% decrease to a 419% increase, and a P-value of 0.25 for testing the null hypothesis of no association (rate ratio of 1, a 0% difference).…”