Joint Pain Forum – News you can use!
Prexige,
Anti-inflammatory Drug, Withdrawn In Canada
06
Oct 2007
As
edited by Joint-Pain-Forum.com
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.
----------------------------
Article
adapted by
www.Joint-Pain-Forum.com from original press release.
----------------------------
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
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