Lumiracoxib (PREXIGE)
Urgent medicine recall
| Level: | Consumer | Class: | I |
|---|---|---|---|
| Reference: | RN-2007-0571 | Date agreed: | 10 August 2007 |
| Product: |
Lumiracoxib (PREXIGE)
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| Sponsor: | Novartis Pharmaceuticals Pty Ltd | ||
| Phone: | 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. | ||
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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. |
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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.