New Zealand’s Medsafe Withdraws Prexige

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) announced that it has revoked consents allowing the supply of 200 and 400 mg tablets of Novartis’ Prexige, a COX-2 inhibitor.

Medsafe said it reached the decision after it reviewed safety data for Prexige relating to reports of severe liver damage in patients using this medication at these dosage levels.

In making the decision, Medsafe discussed the overall risks and benefits of the use of Prexige with medicine regulators in Australia, Singapore and the UK.

Medsafe also reviewed the safety of Prexige 100 mg. Stewart Jessamine, the agency’s interim manager, said frequency of liver damage at this dosage did not appear to be significantly different from that seen for other anti-inflammatory medicines.