Arthritis drug withdrawn due to links with liver problems
Publication Date:21/11/2007
Lumiracoxib, a drug used to treat arthritis, has been withdrawn in the UK because of safety concerns.
What do we know already?
Lumiracoxib is a painkiller that also reduces inflammation. The brand name is Prexige. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It hasn't been a particularly common treatment in the UK, but some people have taken it for osteoarthritis of the knee or hip.
In August 2007, concerns were raised about lumiracoxib after rare reports of severe liver reactions in people taking it, mostly at doses higher than those used in the UK. Doctors in the UK were warned about the risk of side effects and given new advice about prescribing it to reduce the risk to patients, but the drug was allowed to stay on the market.
What does the new report say?
The UK drug safety watchdog has now decided that lumiracoxib should be withdrawn completely. Experts have looked at the most recent research, and said that the risks are big enough to justify banning the drug.
Worldwide, there have been 159 reports of people getting liver problems while taking lumiracoxib. These problems were severe for 20 people, and there were two deaths. Most worryingly, several people got serious side effects while taking a dose normally prescribed in the UK, and within a short time of starting the drug.
Where does the report come from?
The alert comes from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is a government agency that checks the safety of medicines.
What does this mean for me?
The report only affects people taking lumiracoxib. If you take this drug, you'll need to see your doctor and switch to another treatment. There are several similar drugs that your doctor will be able to recommend instead.
It's hard to say how big the risk is for any one person taking lumiracoxib. There have been 159 reports of people getting liver problems around the world, and three in the UK. That's out of more than 8 million prescriptions worldwide, and about 5,000 people taking the drug in the UK. This suggests that liver damage isn't a common side effect, but there's no way of knowing how many people had problems that didn't get reported.
What should I do now?
If you're taking lumiracoxib, you need to make an appointment with your doctor as soon as is convenient, so that you can be switched to another treatment.
If you are feeling unwell, for example, if you feel sick or vomit, get itchy or yellow skin, lose your appetite, feel tired, get stomach pains or have dark urine, you should stop taking lumiracoxib and see your doctor immediately.
However, if you're generally well and your arthritis pain is not too bad, the best thing to do is to stop taking lumiracoxib straight away, and see your doctor within the next few days. Perhaps you can use paracetamol to help ease your arthritis in the meantime. If the pain from your arthritis is severe, and lumiracoxib has been working for you, you can keep taking it until your doctor switches you to a new drug.
If you've taken lumiracoxib in the past, but don't take it now, it's unlikely that you're at risk. But if you're worried for any reason, make an appointment to see your doctor. He or she can arrange a blood test to make sure your liver is working properly.
From:
Medicines and Healthcare products Regulatory Agency (MHRA). Lumiracoxib (Prexige): suspension of marketing authorisations. Available at http://www.mhra.gov.uk (accessed on 19 November 2007).
To read about alternative treatments, see our information on osteoarthritis.
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© BMJ Publishing Group Limited ("BMJ Group") 2007. All rights reserved
This information does not replace medical advice. If you are concerned you might have a medical problem please ask your Boots pharmacy team in your local Boots store, or see your doctor.
