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.