Arthritis drug withdrawn over safety concernsMove follows fears about harm to liver
20 November 2007
The UK’s medicines watchdog has suspended the licence of a drug used to treat arthritis over concerns it may cause liver damage.
The Medicines and Healthcare products Regulatory Agency (MHRA) says patients using Prexige (lumiracoxib) should contact their doctor ‘at the next convenient opportunity’.
The agency is now informing healthcare professionals about the suspension of the drug's licence and has advised them not to prescribe it.
The move comes after the Commission on Human Medicines (CHM) reviewed the latest worldwide data on the safety of the drug.
Threat to liver
Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said: ‘In light of the latest data on liver toxicity associated with lumiracoxib, CHM advised that previous measures could not be relied upon to guarantee patient safety.
‘Patients taking Prexige should make an appointment to see their doctor at the next convenient opportunity.’
Prexige is used to treat painful symptoms of osteoarthritis of the knee and hip and was first made available in the UK in December 2005.
In the UK, about 5,000 patients received one or more prescriptions for lumiracoxib between October 2006 and September 2007.
The MHRA said it had received 23 reports of suspected adverse reactions to lumiracoxib in the UK since March 2006.
Three of these were liver reactions and although none of these reactions was said to have been severe, one patient had to be hospitalised.
The MHRA says that patients who are feeling well and who are gaining benefit from Prexige may continue taking their treatment, but should arrange an appointment with their doctor to discuss alternative treatment.
Patients who are taking Prexige and who feel unwell - if they have nausea, vomiting, loss of appetite, tiredness, stomach pains, dark urine, or itching or yellowing of the skin - should stop taking Prexige immediately and arrange to see their doctor as soon as possible.
A Europe-wide review of the risks and benefits of treatment with Prexige will now be conducted and further advice will be issued when the review has concluded.