Retapamulin prescriptions and monitored off-label use.

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.