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:
- with any current hepatic disease
- with prior drug-induced significant (>3x Upper Limit of Normal) elevations of transaminases
- with liver transaminases >1.5xULN before treatment, or >3xULN during treatment
- taking other medicines associated with clinically significant hepatotoxicity
In addition, monitoring of liver function (LTFs) is advised as follows:
- Perform baseline LFTs before starting treatment (see third contraindication above)
- Repeat LFTs monthly during continued treatment
- Stop treatment if transaminases >3xULN, repeat in 7 days if transaminases >2xULN
- Conduct LFTs for patients reporting any systemic illness whilst taking lumiracoxib
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.