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Tuesday, Oct 19, 2004

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Doubts over Cox-2 anti-inflammatory drugs loom large

P.T. Jyothi Datta

Mumbai , Oct. 18

IF you have been popping the painkiller and arthritis drug rofecoxib till it was recently withdrawn, do you have reasons to worry?

If your doctor has replaced the locally produced version of rofecoxib in your prescription with another medicine in the same family of Cox-2 anti-inflammatory medicines, does that make you any safer?

Consumers and doctors' worst fears seem to be coming true with no clarity emerging on the safety of next generation anti-inflammatory drugs such as valdecoxib and celecoxib, both from Pfizer.

The situation gets more worrisome in the Indian market as several Indian companies make copies of both these drugs. And in the wake of the recent withdrawal of Merck's Vioxx (rofecoxib) due to the risk of heart attack and strokes, doctors have been shifting to celecoxib and valdecoxib, according to a pharma industry analyst.

However, only late last week Pfizer Inc said that it planned to conduct long-term studies to examine the cardio-vascular safety of its Cox-2 inhibitor Bextra (valdecoxib).

And the situation gets more intriguing with agency reports on Monday stating that Pfizer was to fund a heart-related study on Celebrex, its brand of celecoxib. Pfizer will announce plans for a large-scale clinical trial on the ability of Celebrex to prevent heart attacks and strokes in patients with cardio-vascular disease, the reports said.

And though the study looks at the favourable aspect of Celebrex, as a blood-thinner, the report cautions that data to the contrary could result in Pfizer having to put the brakes on celecoxib as well.

Significantly, the United States Food and Drug Administration (USFDA) position on the issue is: "... FDA will closely monitor other drugs in this class for similar side effects."

Further, it states that all non-steroidal anti-inflammatory drugs (the above mentioned medicines) "have risks when taken chronically, especially of gastro-intestinal bleeding, but also liver and kidney toxicity."

And though Indian pharma companies that make similar versions of celecoxib and valdecoxib stand by their drugs, the shadow cast on the family of Cox-2 drugs only seems to get longer.

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