Prexige : nouvelles restrictions en UK

Title New (interim) restrictions on prescribing of lumiracoxib (Prexige) in UK following concerns over liver safety
Date Published 23/08/2007
Reporter initials Yuet
Reporter surname Wan
Reporter affiliation Hospital Pharmacist
Source MHRA

Abstract After consultation with the MHRA and other European regulators, Novartis, the manufacturer of lumiracoxib (Prexige®), is writing to health professionals to inform them of new restrictions on the prescribing of lumiracoxib. This follows concerns raised worldwide after rare reports of serious liver reactions; mostly relating to daily doses that are higher than licensed in the EU (see link to previous NeLM reports). The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis will be further evaluated by European Regulatory Authorities in September. Any updated advice will be issued following that evaluation. The letter from Novartis is being sent to GPs and hospital doctors who treat osteoarthritis patients, informing them that lumiracoxib is now contraindicated in patients:

• with any current hepatic disease
• with prior drug-induced significant (> 3 x ULN) elevations of transaminases.
• with liver transaminases > 1.5 x ULN before treatment, or > 3 x ULN during treatment.
• taking other medicines associated with clinically significant hepatotoxicity.

The new Liver Function Test (LFT) monitoring advice is:

• Perform baseline LFTs before starting treatment (lumiracoxib is contraindicated if transaminases > 1.5 x ULN).
• Where treatment is needed for longer than 1 month, repeat LFTs (monthly).
• Stop treatment if transaminases > 3 x ULN, repeat in 7 days if transaminases > 2 x ULN.
• Conduct LFTs for patients reporting any systemic illness whilst taking lumiracoxib.
• Patients already on lumiracoxib should be reviewed at their next routine appointment; if continued treatment is considered appropriate (after consideration of overall benefit and risks, and after taking new contraindications into account), then LFTs should be taken.

The letter also stresses that treatment should be limited to the shortest duration necessary and should not exceed the recommended 100mg daily. The need for continued treatment should be frequently reassessed. In addition, doctors should counsel their patients for possible signs and symptoms of hepatic injury such as nausea, vomiting, anorexia, malaise, fatigue, dark urine and right upper abdominal discomfort, as well as specific symptoms such as itching or jaundice. Patients should be advised to stop treatment in the event of any symptoms and seek urgent advice from their doctor.

A series of Questions and answers are also available on the MHRA website at the above link.

http://www.nelm.nhs.uk/Record%20Viewing/viewRecord.aspx?id=584528