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Related Experiment Video

Updated: Apr 28, 2026

Author Spotlight: Developing Tools to Tune the Activity of Tyrosine Phosphatases

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Published on: September 6, 2024

Retapamulin prescriptions and monitored off-label use.

Linda M Mundy¹, Tim Sampson, John W Logie

¹WorldWide Epidemiology, Quantitative Sciences, GlaxoSmithKline, LLC, Collegeville, PA, USA, linda.m.mundy@gsk.com.

Paediatric Drugs

|June 18, 2014

Summary

Retapamulin prescriptions in infants under 9 months were low. This study monitored off-label retapamulin (a topical antibiotic) use in young children, suggesting a need for improved pediatric drug safety reporting.

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Area of Science:

Pediatric Pharmacology
Infectious Disease Treatment

Background:

Retapamulin is a topical pleuromutilin antibiotic approved for impetigo and infected traumatic lesions.
Its use is indicated for adults and children over 9 months old.

Purpose of the Study:

To monitor retapamulin prescription patterns in children younger than 9 months.
To assess the frequency of off-label drug use in a vulnerable pediatric population.

Main Methods:

A 5-year observational study analyzed prescription data from the UK Clinical Practice Research Datalink (CPRD) and USA's Clinformatics™ DataMart Multiplan (IMPACT).
Prescription events in children under 9 months were identified and quantified.

Main Results:

In the UK CPRD (2008-2011), 2% of retapamulin prescriptions (3/148) were for infants under 9 months.
In USA's IMPACT (2007-2011), 3.3% of retapamulin claims (1,951/59,210) were for infants under 9 months.

Conclusions:

Off-label retapamulin use in infants under 9 months was found to be relatively low.
The study highlights the need for robust off-label drug reporting schemes to enhance pediatric drug safety.