MHRA suspends COX-2 licence

GPs must stop prescribing the painkiller lumiracoxib (Prexige) and switch patients to an alternative drug, says the Medicines and Healthcare products Regulatory Agency (MHRA).

Concerns over liver damage caused by the COX-2 inhibitor has led to suspension of the drug's UK licence by the MHRA.

It follows similar moves by Australia, New Zealand, the US and Canada earlier this year.

Data has shown an increase in the number of serious liver reactions with the licensed 100mg dose, some of which occurred within one month of use.

The drug was licensed for pain relief in osteoarthritis of the knee and hip and has been available in the UK since December 2005.

Between October 2006 and September 2007 around 5,000 UK patients were given one or more scrips for the drug.

Up to 13 November, the MHRA received 23 reports of severe adverse reactions, three of which were liver reactions.

In August, the MHRA said the drug must be contraindicated in patients with a history of liver problems.

But after closer examination, the MHRA's Committee on the Safety of Human Medicines ruled that 'previous measures could not be relied upon to guarantee patient safety'.

The finding adds to concerns about COX-2 inhibitors.

A spokeswoman for manufacturer Novartis advised GPs to make appointments for patients as soon as convenient to discuss switching to an alternative drug.

'Novartis continues to believe Prexige is an important treatment option,' she added.

Dr Bill Beeby, chairman of the GPC prescribing sub-committee, said: 'No single drug can be recommended as a substitution.'

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins


Already registered?

Sign in

Follow Us: