Health Canada stopped the sale of Novartis's anti-inflammatory drug Prexige Thursday and revoked its market authorization in this country because it may cause "serious" liver damage, the ministry said.
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).
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"The decision to withdraw market authorization for Prexige follows a review of additional safety information submitted by the drug manufacturer," Health Canada said in a statement.
It asked Swiss giant Novartis Pharmaceuticals for the data after Prexige was removed from the Australian market in August, following reports of "serious liver adverse events" linked to the drug at doses of 200 mg and 400 mg daily.
"As a result of its review, Health Canada has concluded that the risk of serious liver-related adverse events with Prexige cannot be safely and effectively managed at the 100 mg daily dose," the ministry said.
There have been four cases internationally, including two in Canada, of hepatitis associated with the use of Prexige at the 100 mg dose, it said.
In a statement, Novartis urged patients in Canada to "stop taking this treatment immediately and contact their doctor to seek advice on other treatment options," in compliance with Health Canada's decision.
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.
Source: AFP
LIN/C
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"As a result of its review, Health Canada has concluded that the risk of serious liver-related adverse events with Prexige cannot be safely and effectively managed at the 100 mg daily dose," the ministry said.
There have been four cases internationally, including two in Canada, of hepatitis associated with the use of Prexige at the 100 mg dose, it said.
In a statement, Novartis urged patients in Canada to "stop taking this treatment immediately and contact their doctor to seek advice on other treatment options," in compliance with Health Canada's decision.
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.
Source: AFP
LIN/C
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