Abstract
Purpose
An analysis of Italian spontaneous adverse drug reactions (ADR) reporting database highlighted a potential association between hypothermia and ibuprofen in children. Hypothermia is defined as a core body temperature of 35 °C (95 °F). Ibuprofen is the most prescribed NSAID for the treatment of fever and moderate pain in children. We aimed to analyze the cases of ibuprofen-associated hypothermia retrieved in the Italian database in order to contribute to the discussion on this potential association.
Methods
We extracted all suspected cases of ibuprofen-associated hypothermia from the Italian spontaneous reporting database and from VigiBase up to December 2015.
We considered the proportional reporting ratio (PRR) as a measure of disproportionality for the Italian cases and the information component (IC) for the reports from VigiBase. We performed a case-by-case analysis to exclude duplicates.
Results
Nineteen cases of hypothermia associated with ibuprofen use were retrieved from the Italian spontaneous reporting database (PRR 19.8, CI 95 %, 12.0–32.9). The reports concerned ten females and nine males with an average age of 2.5 years.
Up to 31 December 2015, 168 cases of hypothermia associated with ibuprofen were reported to VigiBase, with an IC of 2.05 (IC025, 1.82). Among these, 126 cases involved children (49 % males) with an average age of 4.4 years.
Conclusions
Although the risk of this ADR is unknown so far, the widespread use of this drug recommends the need for further studies to better characterize this possible association. Clinicians and pharmacists but also parents should be aware that this risk is theoretical as not yet been confirmed.
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Acknowledgments
L. S. is member of the Italian Medicines Agency (AIFA). The opinions expressed herein are those of the author and do not necessarily reflect the views of the AIFA.
Monia Donati, Chiara Biagi, Domenico Motola, and Alberto Vaccheri were involved in the study conception and planning. Mauro Melis, Luca Monaco, Laura Sottosanti Domenico Motola, Monia Donati, Chiara Biagi, and Alberto Vaccheri were involved in the acquisition, analysis, or interpretation of the data. Monia Donati, Luca Monaco, Mauro Melis, and Laura Sottosanti drafted the manuscript. Domenico Motola, Chiara Biagi and Alberto Vaccheri helped in the critical revision of the manuscript for important intellectual content. All authors approved the final version of the manuscript.
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Donati, M., Monaco, L., Melis, M. et al. Ibuprofen-associated hypothermia in children: analysis of the Italian spontaneous reporting database. Eur J Clin Pharmacol 72, 1239–1243 (2016). https://doi.org/10.1007/s00228-016-2088-z
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DOI: https://doi.org/10.1007/s00228-016-2088-z