Drug regulators in Britain have ordered an arthritis drug to be withdrawn, after growing evidence that it can cause liver damage.

Prexige, made by Novartis, has been linked to 20 cases of severe liver damage worldwide since it was introduced in 2005, including two deaths and three cases where patients needed liver transplants.

In Britain there have been 23 reports of adverse liver reactions since March last year, according to the Medicines and Healthcare products Regulatory Agency. None has been severe and there have been no deaths or transplants.

But, combined with growing international evidence, the data prompted the agency to suspend the licence for the drug yesterday. Novartis asked patients taking Prexige – about 5,000 in Britain – to contact their GP to discuss alternative drugs.

The downfall of Prexige (lumiracoxib) is the latest problem to hit a group of drugs once thought to provide the answer to controlling pain in arthritis without dangerous side-effects. The most prominent casualty was Vioxx, made by Merck, which the company withdrew after it was linked to heart problems.

Last week Merck agreed to pay $4.85 billion (£2.4 billion) to settle the bulk of lawsuits arising from injuries claimed to have been caused by Vioxx.

Prexige, another member of the group of drugs known as coxibs or COX2 inhibitors, is estimated to have been used by 8.5 million people in 30 countries since it was first used in Brazil in July 2005. It has since been withdrawn there and in Australia, Canada and Turkey after reports of liver damage.

It never won a licence in America, where the Food and Drug Administration took the view that Novartis needed to provide more data to show that it was better than drugs already on the market.

Worldwide there have been 159 reports of Prexige causing liver reactions, of which 91 were considered serious. Although the rate of reported adverse reactions is low compared with the number of prescriptions issued, Prexige appears to be doomed.

The agency said yesterday that there would be a Europe-wide review of the risks and benefits of the drug. Its action was prompted by evidence that even at the lower dose approved in Europe (100mg), Prexige can cause reactions, sometimes within a month of a patient starting to take it.

The demise of Vioxx and the likely disappearance of Prexige leaves Pfizer’s Celebrex and Merck’s Arcoxia as the only COX2 inhibitors still on the British market.

The class of drugs was designed to improve on older nonsteroidal antiinflammatory drugs (NSAIDs), such as ibuprofen and diclofenac, which can cause ulcers and bleeding in some patients. By selectively inhibiting only one enzyme and not two, the COX2 inhibitors ought to have been safer and equally effective.

Many patients are now back on NSAIDs, because of the disappointments of COX2 inhibitors. Both groups of drugs essentially are pain-killers, used to control the discomfort of arthritis.

Germany and Austria also suspended Prexige’s licence yesterday, dealing a blow to hopes that it would become a big seller. Its sales in Europe were modest, however, amounting to only $8 million in the first nine months of this year.

Novartis said in a statement that the latest analysis of patients taking the 100 milligram, once-daily form of Prexige showed that there had been nine severe cases of liver damage reported worldwide.

That is equivalent to 5.19 events per 100,000 patient-years, which Novartis argued was within the rate to be expected for NSAIDs.

Millions touched by painful disease

9m people in Britain suffer from arthritis
400,000 have rheumatoid arthritis, in which the body attacks itself, causing painful inflammation
200 types of rheumatic diseases, the most common being osteoarthritis

Source: Times Database, Arthritis Care

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