Prexige Associated With Reports Of Liver Damage, Liver Transplants, And Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

An August 11, 2007 Bloomberg article, "Novartis’ Prexige Painkiller Drug Pulled by Australia", let us know about the latest prescription drug recall.

According to this Bloomberg article, eight serious adverse reaction reports about the use of the painkiller Prexige being associated with liver damage have been made to Australia’s drugs regulator, the Therapeutic Goods Administration, "including two deaths and two liver transplants".  These adverse reaction reports apparently formed the basis for this Prexige recall in Australia. 

In more detail, from this August 11 article:

"It seems that the longer people are on the medicine, the greater the chance of liver injury," the [Therapeutic Goods Administration (TGA)] said. Prexige, which is used to treat osteoarthritis as well, is also known as lumiracoxib. "The TGA is, therefore, advising people to stop taking the lumiracoxib immediately." …

John Gilardi, a spokesman for Novartis, declined to comment today on whether the company plans to withdraw Prexige from other markets.

Novartis said most of the cases in Australia were for 200mg doses of Prexige while one was for 400mg, higher than recommended.

"The 100mg dose of Prexige, which is the recommended dose worldwide for treatment of osteoarthritis, has not been associated with an unexpected incidence of liver-related side effects," the company said in a statement.

According to Novartis, more than 7 million prescriptions for Prexige have been written worldwide since this painkiller drug was first approved for use in July 2005. Further, Novartis said that the drug regulators or other health authorities in the 50 countries where Prexige is sold had been notified about the this drug being withdrawn from the market in Australia.

For various reasons, Novartis has not yet sought FDA-approval for Prexige in the U.S.  If and when it does so, however, the drug company may have an uphill battle given this action taken by Australia’s TGA.

P.S.  Health Canada is currently requesting and reviewing new safety information regarding Prexige as concerns these reports of serious liver adverse events in patients using this Cox-2 inhibitor non-steroidal anti-inflammatory drug (NSAID), it was announced on August 16, 2007.  (8/16/07)

P.S.  In an August 23, 2007 Drug Safety Message from the MHRA entitled "New (interim) restrictions on prescription of lumiracoxib, following concerns over liver safety" we learned that Novartis has sent a "Dear Doctor" letter about Prexige (lumiracoxib) to health professionals in the UK and other European countries in order to inform them of new restrictions on the prescribing of Prexige.  (8/23/07)