Thursday, May 17, 2007

Irish regulatory authorities withdraw NSAID due to liver problems.

The Irish medicines regulatory authority, the Irish Medicines Board, have requested the immediate withdrawal from the market of nimesulide, a relatively COX-2 selective NSAID, due to reports of liver toxicity. The drug has been marketed in Ireland since 1995, but is not and has never been licensed in the UK.

According to the Board, there have been 53 liver-related adverse effect reports relating to nimesulide since it was launched in Ireland, including nine cases of liver failure - three fatal. Six patients have required liver transplant. [Editor's note: these figures relate to a population of about 4 million.]

Nimesulide is marketed in Ireland under the brand names Aulin, Mesulid, and Mesine; it is also marketed under a wide range of brand names in a number of other European countries and elsewhere in the world. UK patients will not have received the drug unless prescribed it abroad.

Announcement from the Irish Medicines Board (IMB home page).

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