Withdrawal of Market authorization for Prexige 100 mg (Lumiracoxib) tablets
Health Canada requested “Novartis Pharmaceuticals Canada Inc” (Novartis) to cease the sales and marketing of Prexige tablets. Prexige, a selective Cox-2 inhibitor (class of drug called NSAID), was approved for sale in Canada almost a year ago for the symptomatic treatment of Osteoarthritis at a dose of 100 mg once daily. As there were 2 cases of serious adverse events to the liver reported in Canada, Health Canada reviewed the safety and efficacy data for this and concluded that the risk of serious hepatotoxicity associated with the use of Prexige cannot be safely managed. Hence, Helath Canada requested Novartis to stop sales of Prexige in Canada.
Health Canada advised all prescribers not to start treatment for new patient and to advise patients to discontinue Prexige and Pharmacists not to dispense further prescriptions for Prexige.