It sticks in our throats too
BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.a3178 (Published 05 January 2009) Cite this as: BMJ 2009;338:a3178- Sean Ainsworth, consultant neonatologist, Forth Park Hospital, Kirkcaldy, Fife ,
- Wendy Jones, prescribing support pharmacist, The Breastfeeding Network, Paisley, Renfrewshire
- Correspondence to: S Ainsworth sean.ainsworth{at}nhs.net
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 …
Log in
Log in using your username and password
Log in through your institution
Subscribe from £173 *
Subscribe and get access to all BMJ articles, and much more.
* For online subscription
Access this article for 1 day for:
£38 / $45 / €42 (excludes VAT)
You can download a PDF version for your personal record.