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Arthritis Drug's Side Effects Linked to 300 Deaths

Mar 10, 2005 | The Sydney Morning Herald

As many as 300 Australians may have died from the side-effects of the arthritis drug Vioxx before it was withdrawn from sale worldwide last October, according to medical estimates.

The drug, fast-tracked through clinical approvals in the United States and Australia, was subsequently found to cause dangerous blood clots, which contributed to an increased incidence of heart attacks and strokes.

Les Cleland, a leading rheumatologist at Royal Adelaide Hospital, told the ABC's Four Corners program, screening tonight, he and colleagues had implicated the drug in "certainly more than a thousand events", of which about 30 per cent resulted in deaths.

Before its recall, about 300,000 people in Australia used Vioxx.

In the US, where the drug was more widely prescribed, some experts claim up to 40,000 deaths, the program reported.

Vioxx, made by Merck, was one of the most powerful of a new class of anti-arthritis drugs, called Cox 2 inhibitors, which change the production of certain body enzymes which cause joint inflammation. But the same enzymes, it later emerged, also affect clotting of the blood.

The first of the Cox 2 inhibitors, Celebrex, received fast-track approval from the Australian Therapeutic Goods Administration in mid-1999. A year later it was listed on the pharmaceutical benefits scheme.

In the wake of the Vioxx debacle, the administration is seeking the power to insist on clinical trials even after a drug has won approval. Its principal medical adviser, John McEwen, said the body was seeking the power to put conditions on licences.

At the moment, the administration lacks the power to order large clinical trials of a drug if concerns come to light after it has been approved.

Dr McEwen said he hoped the new powers to force drug makers to be more responsive to concerns about drugs' side effects would be legislated as part of the formation of the new trans-Tasman regulatory agency.

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