Abstract
Introduction
Retapamulin, a topical pleuromutilin that selectively inhibits bacterial protein synthesis, is approved for treatment of impetigo and secondarily infected traumatic lesions in adults and in children older than 9 months of age.
Objective
A 5-year study was conducted to monitor prescription use in children younger than 9 months of age.
Methods
Annual prescription events were monitored in the UK Clinical Practice Research Datalink (CPRD) and the Clinformatics™ DataMart Multiplan (IMPACT), a product of OptumInsight Life Sciences, Inc. (Eden Prairie, MN, USA), from the USA.
Results
In the CPRD, of 148 prescriptions, three (2 %) were identified in children aged less than 9 months between years 2008 and 2011. In IMPACT, of 59,210 claims for retapamulin in children, 1,951 (3.3 %) were categorized as definitive, or uncertain for, less than 9 months of age between 2007 and 2011.
Conclusion
Retapamulin prescription events in children aged less than 9 months were relatively low compared with other recent estimations of off-label pediatric medicines. Our report provides a framework for future investigations and discussions that may facilitate off-label reporting schemes and promote pediatric drug safety.
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Acknowledgments
The authors thank Carlyne Averell, Fanny Mitrani-Gold, and James Lee for critical review of the manuscript.
Conflict of interest
L.M. Mundy, T Sampson, and J.W. Logie are GSK LLC employees and are eligible for stock ownership. The work was conducted as a Marketing Authorization of retapamulin by the European Medicines Agency (EMA) and funded by GSK.
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Mundy, L.M., Sampson, T. & Logie, J.W. Retapamulin Prescriptions and Monitored Off-Label Use. Pediatr Drugs 16, 331–336 (2014). https://doi.org/10.1007/s40272-014-0077-1
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DOI: https://doi.org/10.1007/s40272-014-0077-1