Arthritis drug banned from sale in UK and Germany


London: The drug Prexige (lumiracoxib), used to treat osteoarthritic pain has been suspended from sale by health regulators in the UK and Germany over liver damage fears.

Manufacturer, Novartis, is informing regulatory agencies around the world of these changes, which come after similar actions in other countries in recent months.

Novartis will also comply with a request from the Austrian health authority to suspend sales pending a final decision by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in the European Union.

Patients taking Prexige in the UK, Germany, and Austria are advised to consult their medical practitioner.

Prexige was precribed as 100 mg once-daily treatment for osteoarthritic pain following EU approval through the Mutual Recognition Procedure (MRP) in October 2006. Itis also marketed and sold in Belgium, Cyprus, Hungary, Malta, Portugal, and Sweden.

Other EU countries may decide to independently suspend the marketing authorization or sale of Prexige ahead of a decision by the CHMP, which is expected in December.

Prexige is part of a class of drugs known as a COX-2 inhibitors and liver enzyme changes are a known side effect of these and traditional non-steroidal anti-inflammatory drugs (NSAIDs).

The ban comes The actions in Europe come after an Urgent Safety Restriction was initiated in August 2007 for the Prexige 100 mg dose. Prexige was first withdrawn in August 2007 in Australia where a number of liver side effects were reported, including two deaths, associated with the use of Prexige at doses higher than 100 mg. No deaths have been reported worldwide with the 100 mg dose.

New arthritis drug fears

London: There are health concerns over a new arthritis drug which comes from the same drug family as Vioxx, which is at the heart of a US class action against the manufacturers.

The new drug Prexige, is a Cox-2 inhibitor, an anti-inflammatory, the best-known of which is Vioxx. A law suit against Vioxx manufacturer Merck Sharpe & Dohme, is currently ongoing in which 7,000 Americans claim they suffered heart attacks or strokes after taking it. The drug was removed from the market in 2004.

Prexige’s maker, Novartis, has carried out its biggest-ever trial involving 34,000 patients to prove that the drug is no more likely to cause heart attacks or strokes than standard painkillers such as ibuprofen or naproxen.

Prexige has now been licensed for use in the Britain by the Medicines and Healthcare products Regulatory Agency, the government agency responsible for making sure drugs are safe.

But following the scandal over Vioxx, many GPs are expected to be reluctant to prescribe it.

When Cox-2s became available in the late 1990s, they were seen to reduce the rate of stomach ulcers caused by existing painkillers such as aspirin. Thousands of patients end up in hospital each year because of ulcers linked to painkilling drugs and it is estimated up to 2,500 Britons a year die as a result.

Patients with heart disease or at high risk of a stroke have been advised not to take Cox-2s since Vioxx was taken off the market.

Trials on Prexige show it reduces pain as successfully as some other Cox-2s and nonsteroidal anti-inflammatory drugs. But it reduces the rate of stomach problems, including ulcers, by up to 79 per cent compared with two other commonly-used drugs.

There was no difference in the cardiovascular risk in patients taking the new drug compared with the painkillers ibuprofen or naproxen.