Prexige withdrawn from market

Novartis' COX-2 inhibitor Prexige (lumiracoxib) has been withdrawn from the UK market on the advice of the Commission on Human Medicines (CHM).

The withdrawal follows new reports of serious hepatotoxicity associated with its use at the licensed dose (100mg daily) and after short duration of treatment (less than one month in some cases).

New prescribing restrictions for the drug were implemented in August 2007 after rare reports of severe liver reactions, mostly relating to daily doses higher than those licensed in the EU. However, in light of the new cases of serious hepatotoxicity associated with the 100mg dose, the CHM concluded that these measures could not be relied upon to guarantee patient safety and that further restrictions were unlikely to be practical.

No further prescriptions for lumiracoxib should be issued and patients currently taking the drug should be invited to make an appointment as soon as possible to discuss alternative treatments.

The CHM advises that ideally patients should stop taking the drug immediately but that it would be acceptable for them to continue taking it until the next convenient appointment if they are well and the drug is relieving their symptoms.


Further information: MHRA

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