According to the Canadian health ministry, sale of Novartis's anti-inflammatory drug Prexige was halted on Thursday due to high risk of internal laceration to the liver, mainly hepatitis.

Health Canada also stated that the drugs market authorization will be canceled.

Prexige, a non-steroidal anti-inflammatory drug, has been marketed in Canada since November 2006 for the treatment of osteoarthritis symptoms in adults at a maximum daily dose of 100 milligrams (mg

A report put toghteher by Health Canada there have been four cases internationally, including two in Canada, of hepatitis associated with the 100-milligram dose. Last month, the U.S. Food and Drug Administration rejected Prexige. At the time, Novartis said it would continue talks with the FDA. The drug is still available in Europe. Novartis Pharmaceuticals Canada is a unit of Switzerland's Novartis AG.

The drug manufacturer, however, noted there were "no cases of jaundice or hepatic failure" in clinical trials of Prexige at 100 mg once-daily dosing.

As well, only 0.85 percent of patients had elevations of the liver enzymes aspartate aminotransferase and alanine aminotransferase -- liver damage markers -- similar to levels observed with other currently available non-steroidal anti-inflammatory drugs, Novartis said.

Australia's drug regulatory agency, the Therapeutic Goods Administration, removed Prexige from its market in August after eight reports of side effects involving serious liver problems when people took Prexige in 200 milligram and 400 mg doses daily. Two of the people involved died and two required liver transplants.

Following the Australian decision, Health Canada undertook a review of the drug's safety data. In its statement Thursday the drug regulator said it had reached the conclusion the risk of serious liver-related adverse events cannot be safely managed at the 100 mg daily dose, which Canada had set as the drug's daily maximum dose.