Drug withdrawn over health concerns

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The Medicines and Healthcare products Regulatory Agency (MHRA) ordered Prexige, which has been available in the UK since December 2005, to be withdrawn from the market.

The Agency is now informing healthcare professionals about the suspension of the drug's licence and has advised them not to prescribe it.

A spokesman for the MHRA said the decision had been taken after the Commission on Human Medicines (CHM) reviewed the latest worldwide data on the safety of Prexige, which is also known as lumiracoxib.

"Importantly, the latest data shows an increase in the number of cases of serious liver reactions that have occurred with the licensed 100mg dose, and in some cases the reactions have been associated with short term use," the spokesman said.

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."

Prexige had previously been subjected to prescribing restrictions for patients with current or previous liver problems, and additional requirements for blood tests before and during treatment for other patients.

The drug was used to treat painful symptoms of osteoarthritis of the knee and hip and approximately 8.5 million prescriptions for the treatment have been written 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 related to liver problems, although none of the reactions were said to have been severe.

The MHRA spokesman added: "A report of a suspected adverse reaction does not necessarily mean that it was caused by the drug. Factors such as other medicines taken at the same time or the patient's underlying condition need to be taken into account when considering whether the drug caused the reaction."