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Lumiracoxib (Prexige)

Medicine recall

10 August 2007
Level: Consumer
Class: I
Reference: RN-2007-0571
Date agreed: 10 August 2007
Product:

Lumiracoxib (PREXIGE)

100mg tablets (AUST R 128635)
200mg tablets (AUST R 104279)
400mg tablets (AUST R 104280)

Sponsor: Novartis Pharmaceuticals Pty Ltd
Contact: 1800 671 203
Reason: The Therapeutic Goods Administration has cancelled the registration of Lumiracoxib because of serious liver side effects associated with the use of the drug.

Patients taking Lumiracoxib should stop taking the medicine now and discuss alternative treatments with their doctor.

Recall letters are expected to be dispatched by the sponsor within the next week. Advertisements are also expected to be placed by the sponsor to advise on their returns policy.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.