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Novartis AG has withdrawn a painkiller from the Australian market after two patients died and two others had to undergo liver transplants.
The drug company said patients in Australia should stop taking Prexige® (lumiracoxib) immediately, return any remaining tablets to their pharmacist and seek medical advice on alternative treatment.
Novartis issued the recall after Australia’s Therapeutic Goods Administration said it had received eight reports of serious adverse liver reactions in people taking the drug.
The company’s principal medical adviser, Dr Rohan Hammett, said: “It seems that the longer people are on the medicine, the greater the chance of liver injury.”
The drug was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in 2003 and this approval still stands, although Prexige is currently on the “black triangle” scheme.
Medicines on this list are intensely monitored to establish their risks and benefits and to identify any previously unknown side-effects as quickly as possible.
The Swiss firm said its drug is still available in about 50 countries, although it is not sold in the USA.
Novartis added that serious side-effects are rare for nonsteroidal anti-inflammatory drugs such as Prexige.
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