The UK Medicines and Healthcare Products Regulatory Agency (MHRA) claims to “enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.”1 Why is it then that instead of changing advice in the summary of product characteristics for the most effective treatment for oral thrush2 to minimise the potential for harm they instead make it an “off licence” product for the very group most in need of it?3

Miconazole oral gel was launched in 1978 and has been used to treat countless infants with symptoms of oral thrush. After more than 30 years of unchanged use the manufacturer, Janssen-Cilag, with the support of the MHRA, chose to change its licensed use in May 2008 such that it is no longer recommended in infants aged under 4 months.3 You might assume that this action was taken in the light of serious adverse events, possibly even a fatality. But no, the reason for the change is the potential …