U.K.: Arthritis Drug Lumiracoxib Suspended By Regulators

HARROGATE (Legal & Medical Magazine), November 21, 2007: Arthritis drug Prexige has had its licence suspended by UK regulators over fears it may cause serious liver damage. The Medicines and Healthcare Products Regulatory Agency (MHRA) ordered that Prexige (also known as lumiracoxib) be withdrawn from the market, after analysis of the latest data by the Commission on Human Medicines (CHM) confirmed there had been ‘an increase in the number of cases of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 drug – used to treat painful symptoms of osteoarthritis – had been placed under prescribing restrictions for patients with current or previous liver problems since August 2007, with all other patients required to take blood tests before and during lumiracoxib treatment. Dr June Raine, the director of vigilance and risk management of medicines at the MHRA, said: “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.” The MHRA estimate 8.5 million prescriptions have been written worldwide since July 2005 – the drug has only been available in the UK since January 2005 – and around 5,000 of these were for UK patients between October 2006 and September 2007. There have been 23 reports of adverse reactions to lumiracoxib in the UK since March 2006, three of which were related to liver problems. Patients currently taking Prexige are advised to make an appointment to see their doctor at the next convenient opportunity. Prexige becomes the third COX-2 inhibitor to be withdrawn from the market in just over three years, after Vioxx and Bextra were withdrawn in September 2004 and April 2007, respectively, when they were found to pose serious health risks to patients. In addition to this, other arthritis pain relief drugs Celebrex and Arcoxia are recognised to have serious side effects for users. A spokesman for medical charity Arthritis Research Campaign said the suspension of Prexige was a big blow for the osteoarthritis sufferers. “This was the newest drug in the class of COX-2 painkillers and touted as the one that did not have side effects…of other, similar drugs. But it’s now been shown to have different but equally undesirable side effects of its own. “This means there is even less choice available for people with osteoarthritis,” added the spokesman. A spokesman for patient advice organisation, Arthritis Care, said: “We know this announcement may cause concern to people with arthritis. Copyright © 2007 Barker Brooks Media Ltd