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Prexige for arthritis withdrawn in UK, Germany and Austria

UK, German and Austrian drug regulators have suspended the licence of Novartis' arthritis drug Prexige due to concerns it may cause liver damage

UK, German and Austrian drug regulators have suspended the licence of Swiss-based pharmaceutical group Novartis' arthritis drug Prexige (lumiracoxib) due to concerns it may cause liver damage.

In UK Medicines and Healthcare products Regulatory Agency (MHRA) ordered Novartis to withdraw Prexige from the UK market on 19 November. The product has been available in the UK since December 2005 and was used to treat pain caused by osteoarthritis of the knee and hip.

Approximately 8.5 million prescriptions for the treatment have been written worldwide since its launch in July 2005, including approximately 5,000 British patients in the past year, according to the UK campaigning newspaper, The Guardian.

In the UK, there have been 23 reports of suspected adverse reactions to lumiracoxib since March 2006, three of which were related to liver problems, although none of the reactions were severe. The drug had previously been subjected to prescribing restrictions for patients with current or previous liver problems, as well as additional requirements for blood tests before and during treatment for other patients.

A spokesperson for the MHRA said the decision to suspend the drug's licence had been taken after the Commission on Human Medicines reviewed the latest worldwide data on the safety of Prexige, saying that an increase in the number of cases of serious liver reactions was observed with the licensed 100mg dose, and in some cases the reactions had been associated with short-term use.

The MHRA added that 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."

The agency advises patients who are feeling well and who are gaining benefit from Prexige could continue taking the drug, but should arrange an appointment with their doctor at the next convenient opportunity, to discuss an alternative treatment. Patients taking Prexige who feel unwell should stop taking it immediately and arrange to see their doctor as soon as possible, the MHRA added.

A EU review of the risks and benefits of treatment with Prexige will now be conducted and further advice will be issued.

A spokesperson for the Arthritis Research Campaign said the withdrawal of Prexige was a major blow for osteoarthritis sufferers and represented the end for COX-2 Inhibitors, the most infamous of which was Merck & Co's Vioxx (rofecoxib).

Prexige is available in some European countries as a 100 mg once-daily treatment for osteoarthritic pain following EU approval through the Mutual Recognition Procedure (MRP) in October 2006, with the UK as the reference member state. Prexige is also marketed and sold in Belgium, Cyprus, Hungary, Malta, Portugal and Sweden.

In the first nine months of 2007, Prexige had net sales of USD 8m in Europe.

In August 2007, PMLive reported that the Therapeutic Goods Administration regulatory body of Australia rejected the registration of Prexige also over liver-related toxicity.

30th September 2008

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