New contraindications and monitoring advice for Prexige

New restrictions on the prescribing of Prexige (lumiracoxib) have been enforced following consultation between the manufacturer, the MHRA and other European regulators.

This follows concern raised worldwide after rare reports of serious liver reactions mostly relating to daily doses higher than the licensed daily dose of 100mg in the EU.

The new prescribing advice states that lumiracoxib is now contraindicated in patients with:

  • Current hepatic disease.
  • Prior drug-induced significant (>3xULN) elevations of transaminases.
  • Liver transaminases >1.5xULN before treatment, or >3xULN during treatment (see below).
  • Taking other medicines associated with clinically significant hepatotoxicity.

    New liver function test (LFT) monitoring advice states:
  • Perform baseline LFTs before starting treatment (lumiracoxib is contraindicated if transaminases >1.5xULN).
  • Where treatment is needed for longer than one month, repeat LFTs on monthly basis.
  • Stop treatment if transaminases >3xULN, repeat in seven days if transaminases >2xULN.
  • Conduct LFTs for patients reporting any systemic illness whilst taking lumiracoxib.

Patients already taking 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 performed.

The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis is currently being evaluated by european regulatory authorities and any updated advice will be issued following the evaluation.

Further information: www.mhra.gov.co.uk.

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