Prexige 200mg and 400mg tablets to be withdrawn in New Zealand

Consents allowing the supply of 200mg and 400mg tablets of the COX-2 anti-inflammatory medicine Prexige have been revoked in New Zealand by the Medicines and Medical Devices Safety Authority, Medsafe.

Novartis, the pharmaceutical company sponsoring the medicine, is issuing a recall notice to suppliers of the tablets today.

The decision has been reached by Medsafe after it reviewed local and international safety data for Prexige relating to reports of severe liver damage in patients using this medication at doses of 200mg and above. In making the decision, Medsafe discussed the overall risks and benefits of the use of Prexige with medicines regulators in Australia, Singapore and the United Kingdom.

Medsafe also reviewed the safety of Prexige 100mg the product indicated for use in osteoarthritis.

Medsafe has accepted the interim advice of the Medicines Adverse Reactions Committee (MARC) that Prexige 100mg should remain on the market and its safety be closely monitored.

To bring this into effect Medsafe has: decreased the maximum daily dose of Prexige to 100mg; limited the approved indication to the treatment of osteoarthritis; and added warning statements to the prescriber and patient information sheets for Prexige advising that patients should have blood tests to assess their liver function before starting treatment and every month thereafter.

Medsafe and the Medicines Adverse Reactions Committee (MARC) will continue to closely monitor the safety of Prexige 100mg tablets, and will review its ongoing availability in light of any new data that emerges.

In addition to the recall of Prexige 400mg, Novartis will provide written advice on the safety issues associated with Prexige to pharmacists and doctors. This advice will include the need to conduct monthly monitoring of patients’ liver function and to report any abnormalities to the Centre for Adverse Reactions Monitoring in Dunedin.

The sale of this product in the Kingdom of Saudi Arabia is not authorized, is not legally available on the Saudi market. But it is possible that this product is available to some frequent international travelers, internet buyers and through special purchase requests made by Saudi residents. Accordingly, the Saudi Food and Drug Authority encourages consumers to avoid using this medication (product).

Source : Medsafe 21 August 2007