- Prescribing Advice for GPs - https://www.prescriber.org.uk -

MHRA issues lumiracoxib advice

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued interim advice restricting the use of lumiracoxib following concerns over liver safety.

A letter will be sent from the manufacturer to healthcare professionals advising that lumiracoxib is now contraindicated in patients:

In addition, monitoring of liver function (LTFs) is advised as follows:

There have been no reported fatalities in the UK linked to lumiracoxib perhaps because this drug has not been widely used; the MHRA estimate some 5,400 patients have been prescribed lumiracoxib in the last year in the UK compared to over 7 million patients globally since launch in July 2005. European Regulatory Authorities may amend this advice following a full review of risks and benefits of lumiracoxib in September.

Action: Previous advice suggested that it was difficult to foresee a place in therapy for lumiracoxib. Clinicians should be aware of this new advice. Monitoring should be conducted as specified and treatment changed to safer alternatives where possible.