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Novartis pulls painkiller from Australian market after deaths

BASEL, Switzerland: Novartis AG said it has removed its pain relief drug Prexige from the Australian market, which the national drug regulator called for after two patients died and two others had to undergo liver transplants.

Patients in Australia should stop taking the medication immediately, return any remaining tablets to their pharmacist and seek medical advice on alternative treatment, Novartis said in a statement posted on its Web site.

Australia’s Therapeutic Goods Administration said it had received eight reports of serious adverse liver reactions in patients taking the drug.

“It seems that the longer people are on the medicine, the greater the chance of liver injury,” its principal medical adviser, Dr. Rohan Hammett, said in a statement.

The Swiss company said the drug — which is not sold in the United States — is still available in about 50 countries. Australia is the only country where Prexige is available in a 200 milligram dose, as opposed to the standard 100 milligram dose sold elsewhere.
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Novartis said the company was already reducing the dosage of the drug in Australia when national regulators requested its withdrawal.

“Although we’re working with (the regulators), we still believe in the risk-benefit profile of the drug,” said spokesman John Gilardi.

Novartis said serious side effects were rare for non-steroid anti-inflammatory drugs such as Prexige.

It said an estimated 60,000 patients have used Prexige in Australia since November 2005, mostly for pain relief in connection with osteoarthritis.

Sales of the drug reached US$52 million in the first half of the year, said Gilardi.

Novartis shares rose 0.3 percent to close at 65.15 Swiss francs (US$54.04; €39.59) on the Zurich exchange.

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