Health Canada (Santé Canada) has announced (4th October) that it has stopped the sale of the anti-inflammatory drug lumiracoxib▼ (Prexige®) in Canada and will cancel the drug’s market authorisation “due to the potential for serious liver-related adverse events”.
Health Canada requested information from the drug’s manufacturer, Novartis, after lumiracoxib▼ was removed from the Australian market on 10th August, also because of concerns about liver side-effects.
We noted a few days ago that the Food and Drugs Administration (FDA) has declined to approve lumiracoxib▼ for use in the USA, according to a press release from the manufacturer (which implies that liver side-effects were the chief concern of the FDA).
In the UK and Europe, Novartis sent a letter to healthcare professionals advising on revised contraindications and monitoring recommendations in patients prescribed lumiracoxib▼.
The concern about lumiracoxib’s▼ potential for rare but serious, even fatal liver reactions must feature in prescribing decisions about the drug, along with the increased risk of thrombotic events seen with all coxibs (note that all coxibs are now contraindicated for people with established ischaemic heart disease, cerebrovascular disease and peripheral artery disease, and individual risk assessment is appropriate for patients with risk factors for cardiovascular events)
Health professionals should be aware of the continuing concerns about lumiracoxib▼, and follow the manufacturer’s advice regarding measuring liver enzyme levels of patients currently prescribed it and for whom in might be started. Lumiracoxib is a “black triangle” drug (marked with ▼ in books such as the BNF and MIMS) because it is under intensive surveillance by the MHRA. All suspected reactions to black triangle drugs, whether serious or not, should be reported to the MHRA.