Prexige, Anti-inflammatory Drug, Withdrawn In Canada

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Main Category: Arthritis / Rheumatology
Also Included In: Pain / Anesthetics;  Bones / Orthopedics
Article Date: 06 Oct 2007 - 10:00 PDT

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The sale of Prexige (lumiracoxib) has been stopped in Canada. Health Canada advises that it will cancel the medication's market authorization because of potential for serious liver-related adverse events.

Prexige is a Cox-2 selective inhibitor non-steroidal anti-inflammatory drug. It has been on the market in Canada since November 2006. The drug is used for treating adult patients with the signs and symptoms of osteoarthritis - maximum dose 100 mg (daily).

After Canadian authorities reviewed additional safety information submitted by Novartis Pharmaceuticals Canada, Inc., it was decided to withdraw authorization for Prexige. The additional information was sought soon after the same drug was pulled from the Australian market this year, due to reports of serious liver adverse events that were associated with the drug at doses of 200mg and 400mg per day.

Health Canada concluded, after reviewing the additional safety information, that it is not possible to safely manage the risk of liver-related adverse events with daily doses of 100mg.

Two cases of liver-related adverse events linked to Prexige use have been reported to Canadian authorities since the drug's approval. Four cases have been reported worldwide for daily doses of 100mg.

Health Canada urges patients who are currently taking Prexige to contact their health care provider and discuss other treatment options. Do not dispose of the product yourself, asks Health Canada - return it to your pharmacy to ensure appropriate disposal.

-- Health Canada
-- www.prexige.com

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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