NPC Archive Item: Prexige® (Lumiracoxib) marketing authorisation suspended

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.

merec_stop_press NPC Logo

Update (14/12/07):
The withdrawal of lumiracoxib has been recommended across all EU Member States after a Europe-wide review, the MHRA has anounced.

The Medicines and Healthcare products Regulatory Agency has suspended the marketing authorisation for lumiracoxib (Prexige®) with immediate effect, according to a press release. UK pharmacists and distributors are being asked to return the product to the company.

This follows interim advice restricting its use earlier this year following safety concerns about possible liver damage. A review of the most recent worldwide data has shown that liver reactions have occurred in patients taking low doses and for short periods.

Patients who are taking lumiracoxib and who feel well may continue with treatment but are advised to book a non urgent appointment to discuss alternative treatments. Patients taking the drug who feel unwell (particularly nausea, vomiting, loss of appetite, tiredness, stomach pains, dark urine, or itching or yellowing of the skin [jaundice]) are advised to stop treatment and arrange to see their doctor immediately.

Bottom line: Clinicians should be aware of this suspension. Patients will need their treatment reviewed and a suitable alternative should be prescribed.

This article is based on a blog by Matt Robinson and can be accessed at

Please comment on this blog in the NPC discussion rooms, or using our feedback form.