Prexige is a selective COX-2 inhibitor in the class of drugs called NSAIDs ( non-steroidal anti-inflammatory drugs ).
In New Zealand, Novartis has informed Health Care Professionals of important new safety information about serious liver side effects mainly observed with chronic use of doses higher than 100 mg of Prexige ( Lumiracoxib ) tablets:

• In a recent review of international spontaneous post-marketing reports, eight cases of serious liver side effects have been reported, including two deaths, in patients on chronic treatment primarily at doses higher than Prexige 100 mg.
Liver failure is a known rare but serious side effect of all COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs ( NSAIDs ).

• The 100 mg dose of Prexige, which is the recommended dose worldwide for treatment of osteoarthritis, has not been associated with an unexpected increase in incidence of liver-related side effects for an osteoarthritis population treated with NSAIDs.

In order to manage the risk of liver toxicity with Prexige, Novartis has advised Health Care Professionals of the following:

• Prexige is now only available in the 100 mg tablets dosage form. Prexige is now only indicated for the symptomatic treatment of osteoarthritis ( OA ).
The indications for primary dysmenorrhoea, acute pain and acute gout have been removed.

• Prexige 400 mg tablets are being recalled from pharmacies and must not be prescribed for any new patients. Prescribers should contact those existing patients taking the 400mg tablets and consider the use of other analgesics.

• The recommended dose of Prexige for osteoarthritis is 100 mg once daily, with or without food, for the shortest duration consistent with individual patient treatment goals. The 100 mg dose should not be exceeded as this does not provide any additional benefit and may increase the risk of adverse events. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.

• Liver function monitoring is recommended at baseline and monthly thereafter while on therapy. Patients with a baseline AST/ALT > 1.5xULN should not be commenced on Prexige. Patient taking lumiracoxib who develop signs and/or symptoms suggestive of liver dysfunction should be investigated promptly.
Prexige should be discontinued if elevations of AST/ALT > 3xULN occur.

• Patients who continue on Prexige100 mg should return to their prescribing doctor as soon as possible for liver function monitoring, to be repeated at monthly intervals.

• Patients using Prexige 100mg tablets should be informed about the signs and symptoms of liver disease ( i.e. nausea, vomiting, tiredness, weakness, loss of appetite, jaundice, easy bruising ) and should be instructed to return to their doctor immediately if they have any of these signs and symptoms, rather than waiting until their next follow-up visit.

The clinical trial database for Prexige comprises approximately 40,000 patients from randomized, placebo and active controlled trials of up to one year duration, making it one of the largest bodies of evidence for any drug in its class. This includes the TARGET study involving more than 18,000 patients, which showed that Prexige significantly reduced serious gastrointestinal events without compromising cardiovascular safety compared to the NSAIDs Naproxen and Ibuprofen. In this study 6 cases ( 0.07% ) of serious liver abnormalities were observed with Prexige. The abnormalities resolved on cessation of Prexige and no cases of liver failure, transplantation or death attributable to drug induced hepatitis were reported.

Source: MedSafe, 2007

XagenaMedicine2007



Link: Xapedia - Medical Encyclopedia