Lumiracoxib (Prexige) withdrawal
admin November 20th, 2007
Lumiracoxib has been withdrawn from the UK market after a series of spontaneous reports of liver toxicity collected worldwide. Lumiracoxib was withdrawn in Canada last month, and in August of this year the MHRA imposed some restrictions on the use of lumiracoxib. Further cases have undermined the usefulness of that advice:
Recently, several new cases of serious hepatotoxicity have been identified following exposure to the licensed 100mg dose, and after short duration of treatment (less than one month in some cases). CHM concluded that recently introduced risk minimisation measures (baseline and monthly liver function test monitoring, and contraindications for patients with current or previous hepatic dysfunction) cannot be relied upon to guarantee patient safety, and further restrictions are unlikely to be practical. CHM considered that urgent action was required in order to protect public health, and that suspension of Marketing Authorisation for lumiracoxib was warranted.
A further press release and advice is available at the MHRA website.
Bottom line: Patients who are obtaining benefit from lumiracoxib may continue treatment until they have arranged an appointment with their doctor at the next convenient opportunity, at which alternative treatment can be discussed. Patients who are taking lumiracoxib and who feel unwell should stop taking lumiracoxib immediately seek medical attention. Any adverse effects to lumiracoxib should be reported at yellowcard.gov.uk.