Tuesday, November 07, 2006

Canada OKs limited use of Novartis arthritis drug

Prexige was officially introduced today as the first COX-2 inhibitor to be approved in Canada since the withdrawals of Bextra and Vioxx.

The articles mention that Prexige was approved with restrictions. As far as I can see, it has been only given an indication to treat arthritis in the knee, even though the anti-inflamatory effect likely extends to other body parts as well. I suspect that this limited indication won't stop the product from being prescribed "off label" for other body parts such as the hip (which Prexige is approved for in the European Union).

From Reuters:
Canada has approved the limited use of Novartis's arthritis drug Prexige, the first new medication to be allowed in a class of drugs that had come under question because of possible heart problems.

The Swiss drugmaker announced the Canadian approval on Tuesday for treating arthritis in the knee, hours after it said the European Union approved the same drug for knees and hips.

From the Canadian Press:
Health Canada has approved a new COX-2 inhibitor which has been shown to offer relief from arthritis symptoms without the same heart problems associated with other drugs in its class, such as Vioxx and Bextra.

Novartis Canada announced the approval of Prexige in a news release Tuesday. The medication is the first new COX-2 drug to be approved for use in Canada after the drugs came under fire for raising the risk of heart problems. ...more

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