TITLE

COX 2 inhibitor rejected in North America but retained in Europe despite liver risk concerns

AUTHOR(S)
Burton, Bob
PUB. DATE
October 2007
SOURCE
BMJ: British Medical Journal (International Edition);10/20/2007, Vol. 335 Issue 7624, p791
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
This article reports that the cyclo-oxygenase-2 (COX 2) inhibitor Prexige or lumiracoxib has been taken off the market in the U.S., Canada and Australia but will remain on the market in Great Britain. The United States Food and Drug Administration (FDA) has refused to approve the drug due to adverse effects on the liver. Health Canada looked at the drug after Australia pulled the 100, 200 and 400 milligram doses from the market and found the danger to be more significant than the benefit. Canada found that even the 100 milligram dose caused hepatitis. The drug is still available in more than 50 countries in Europe and Latin America.
ACCESSION #
27371207

 

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