Prexige 200mg and 400mg tablets to be withdrawn in New Zealand

Consents allowing the supply of 200mg and 400mg tablets of the COX-2 anti-inflammatory medicine Prexige have been revoked in New Zealand by the Medicines and Medical Devices Safety Authority, Medsafe.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's interim manager, Dr Stewart Jessamine, says Medsafe and the Medicines Adverse Reactions Committee (MARC) concluded that the data for higher doses of lumiracoxib, the active ingredient in Prexige, support an association with liver damage that was greater than that seen for other anti-inflammatory medicines.

"This increased risk of liver damage for Prexige outweighs any of the potential benefits claimed for the 200mg and 400mg dose," Dr Jessamine says.

"We, therefore, have revoked the consent of these doses. However, as there are no products containing 200mg of lumiracoxib marketed in New Zealand only the Prexige 400mg product will be recalled. We believe the recall will affect around 1000 patients who take Prexige 400mg tablets in New Zealand. Anyone who has general concerns should contact their doctor for advice in the first instance."

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

"The data available from clinical trials and reported side effects in the United Kingdom, Europe, Canada or South America indicate that severe liver damage with Prexige 100mg/day is rare. The frequency with which liver damage is reported for Prexige 100mg does not appear to be significantly different from that seen for other anti-inflammatory medicines," Dr Jessamine says.

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.

"When taking a medicine you must take into consideration both the possible benefits and the potential risks as all medicines can cause severe side effects. Patients taking Prexige 100mg tablets for osteoarthritis should contact their doctor about having blood tests to check and monitor their liver function. I also encourage GPs to report any abnormalities found in these tests to the Centre for Adverse Reactions Monitoring at the University of Otago. Patients taking Prexige for acute pain should contact their general practitioner to discuss other analgesics that may be suitable," Dr Jessamine says.

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.

Further information is available on the Medsafe website: http://www.medsafe.govt.nz/hot/alerts.asp