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Prexige - Drug ordered off the market

Drug regulators in Britain have ordered the withdrawal of a popular arthritis drug amid growing evidence that it can cause liver damage.

Prexige, made by Novartis, has been linked to 20 cases of severe liver damage worldwide since its introduction in 2005. This includes 2 deaths and 3 cases where patients needed liver transplants.

In the UK there have been 23 reports of adverse liver reactions since March 2006 according to the Medicines and Healthcare Products Regulatory Agency. None of these reactions have been severe and there have been no deaths or transplants.

Prexige (lumiracoxib) is the latest casualty in a group of medicines that were once hailed as providing the solution to controlling the pain of arthritis without any dangerous side-effects. These drugs are known as COX 2 inhibitors and they were designed to improve on older Non Steroidal Anti Inflammatory Drugs (NSAIDs) such as Ibuprofen and Difrene, which can cause ulcers in some patients. By selectively inhibiting only one enzyme (Cox 2), the inhibitors were thought to have been safer whilst remaining effective.

Prexige joins a number of COX 2 inhibitors that have been removed from the market. Vioxx is the most prominent casualty and was withdrawn from the market in 2004, after it emerged that the drug caused those taking it to suffer heart attacks and strokes. A number of cases have been taken against the manufacturers of the drug, Merck, and last week the company agreed to settle the bulk of lawsuits arising from injuries claimed to have been caused by Vioxx. The settlement will be in the region of $4.85 billion.

Another drug, Nimesulide, was withdrawn from the Irish market in May 2007, following reports that it caused liver damage. Malcomson Law are currently investigating the possibility of litigating on behalf of persons who have suffered as a result of taking Nimesulide, which was sold in Ireland under the brand names Aulin, Mesine and Mesulid.

Prexige is estimated to have been used by 8.5 million people in 30 countries since it was first introduced in Brazil in 2005. it has since been withdrawn there and in Australia, Canada and Turkey following reports that it caused liver damage.

It never won a license in America, where the Food and Drug Administration (FDA) 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.

Whilst Prexige was never available in Ireland, this latest blow casts further shadows on the safety of Cox 2 inhibitors and their future on the worldwide market. The demise of Vioxx and the likely disappearance of Prexige leaves Pfizer's Celebrex and Bextra, along with Merck's Arcoxia as the only Cox 2 inhibitors on both the British and the Irish market.

If you have suffered an adverse reaction to any drug, please contact Malcomson Law by calling 01 8744422 or complete an Online Enquiry Form. A solicitor who specialises in the area of drug and pharmaceutical litigation will contact you to advise you of your legal rights and entitlements.

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