Lumiracoxib, marketed under the brand name of Prexige, is a COX-2 inhibitor belonging to the non-steroidal anti-inflammatory drugs (NSAID) group.

PSA director Debbie Rigby said pharmacists should advise consumers to stop taking lumiracoxib immediately.

Ms Rigby said liver damage had been found only in people who used the drug long-term.

She said pharmacists should advise all patients to take the lowest dose of any NSAID – including COX-2 inhibitors – over the shortest time possible to minimise the risk of side effects.

She said concerned patients should talk with their GPs and have liver function tests (LFTs) to detect abnormal serum transaminases (ALT & AST). The hepatic dysfunction appeared to be dose-related. In the TARGET study1 of more than 18,000 patients aged 50 years and older with osteoarthritis, the incidence of lumiracoxib-induced (400mg daily) serious liver abnormalities was non-significant compared with use of naproxen (500mg twice daily) or ibuprofen (800mg three times daily). The proportion of patients with serum transaminases (ALT/AST) concentrations more than three times the upper limit of normal differed significantly between lumiracoxib and the other NSAIDs. However, all cases of possible or probable lumiracoxib-induced clinical hepatitis resolved on cessation of treatment.

Pharmacists should be particularly alert to the symptoms of hepatic impairment in patients who have been taking lumiracoxib. Signs to look for include: jaundice – yellow staining of the skin and the sclerae (the whites of the eyes); loss of appetite; nausea or vomiting; and dark urine. Any consumer showing such signs should be advised to seek urgent medical treatment.

There may be instances where a consumer has trouble making a timely appointment and needs to use an over-the-counter NSAID in the interim. In such cases pharmacists should take a thorough medication history – in addition to discussing the reasons for the consumer taking lumiracoxib. With this information it may be possible to suggest a short-term over-the-counter substitute.

Prexige’s sponsor – Novartis Pharmaceuticals – issued a statement regarding the medicine’s withdrawal.

The company advised consumers to return unused medicines to pharmacies for a full refund. Pharmacists would be compensated for all returned stock.

Pfizer Australia has released a statement for doctors and pharmacists regarding its COX-2 inhibitor celecoxib (Celebrex) in which it reassures health professionals of that medicine’s hepatic safety profile.