Arthritis drug withdrawn

12 April 2012

British regulators have suspended the licence of an arthritis drug amid concerns that it may cause liver damage, it has emerged..

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products Regulatory Agency (MHRA) ordered Prexige, which has been available in the UK since December 2005, to be withdrawn from the market.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 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: "The MHRA carefully reviewed the latest evidence, and sought independent expert advice from the Commission on Human Medicines.

"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 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.

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