Concerns over liver damage caused by the cyclooxygenase (COX)-2 inhibitor has led to suspension of the drug’s UK licence by the MHRA.
It follows similar moves by Australia, New Zealand, Turkey, the US and Canada earlier this year.
Data has shown that an increase in the number of serious liver reactions that have occurred 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 alone, 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 of the evidence, the Committee on the Safety of Human Medicines, which is part of the MHRA, ruled that ‘previous measures could not be relied upon to guarantee patient safety’.
The latest finding adds to concerns about the side effects of COX-2 inhibitors after research linked them to an increased risk of cardiovascular event.
A spokeswoman for manufacturer Novartis advised GPs to make appointments for patients as soon as convenient to discuss switching to an alternative treatment.
‘Novartis continues to believe Prexige is an important treatment option,’ she added.
rachel.liddle@haymarket.com
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