New Zealand Regulatory Authority, Medsafe, Revokes Consents for Prexige® 200 mg and 400 mg Tablets; Novartis Issues Recall Notice

The Medicines and Medical Devices Safety Authority, Medsafe, has revoked the consents allowing the supply in New Zealand of the COX-2 anti-inflammatory medicine Prexige (lumiracoxib) 200 mg and 400 mg tablets on the grounds that the tablets can no longer be administered or used safely for the purposes indicated in the regulatory application for consent. Novartis has issued a recall notice to suppliers of the tablets. Only Prexige 400 mg will be recalled, affecting about 1000 patients, as there are no products containing 200 mg of lumiracoxib marketed in New Zealand.

The revocation by Medsafe was reached after it reviewed local and international reports of severe hepatic injury in patients using the medication at doses >e;200 mg. In making the decision, Medsafe consulted with regulators in Australia, Singapore, and the UK. Medsafe and the Medicines Adverse Reactions Committee (MARC) concluded that the data for higher doses of lumiracoxib supported an association with liver damage that was greater than that seen for other anti-inflammatory medicines.

Medsafe also reviewed data from clinical trials and reported side effects on the safety of Prexige 100 mg daily indicated for use in osteoarthritis (OA). The data showed that severe hepatic injury was rare, and that the frequency with which liver damage is reported for Prexige 100 mg does not appear to be significantly different from that seen for other anti-inflammatory medicines. Medsafe has accepted the interim advice of the MARC that the drug should remain on the market and its safety be closely monitored.

Medsafe has decreased the maximum daily dose of Prexige to 100 mg, limited the approved indication to the treatment of OA, and added warning statements to the prescriber and patient information sheets for the agent advising that patients should have blood tests to check and monitor their liver function before starting treatment and every month thereafter.

Prexige had consent in New Zealand as 100 mg, 200 mg, and 400 mg tablets and was approved for use in Australia and New Zealand for the short-term treatment of acute pain at doses up to 400 mg per day, and for the management of OA at doses of 100 mg per day.

The Therapeutic Goods Administration of Australia recently revoked the registration of Prexige owing to increasing reports of severe hepatic injury in an estimated 60,000 patients taking this medication at doses of >e;200 mg. The eight cases reported in Australia associated with use of Prexige included two cases of death from liver failure and two patients requiring liver transplants. The Centre for Adverse Reactions in Dunedin, New Zealand, has received a total of 15 case reports of adverse reactions to lumiracoxib in the 2 years since it was approved. There are no reports of hepatic injury with this product in New Zealand.