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Published on 21 November 2007

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MHRA withdraws licence for Prexige


The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the licence for the arthritis drug Prexige (lumiracoxib) over fears it may cause liver damage.

Prexige has been available in the UK since December 2005, but will now be withdrawn from the market.

Prescribing restrictions had previously been put on the drug for patients with liver problems.

The drug was used to treat symptoms of osteoarthritis of the knee and hip, and around 8.5 million prescriptions for the treatment have been issued worldwide since its launch in July 2005, including to around 5,000 British patients in the past year.

In Britain, there have been 23 reports of suspected adverse reactions to lumiracoxib since March 2006, three of which were related to liver problems.

Dr June Raine, director of vigilance and risk management of medicines at the MHRA, said: “The MHRA carefully reviewed the latest evidence, and sought independent expert advice from the Commission on Human Medicines (CHM).

“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.”

Copyright © PA Business 2007


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