The Hindu Business Line : Doctors advise caution on arthritis drug

IF you are an arthritis patient taking a locally-made version of Pfizer's drug Celebrex or celecoxib - it is time to sit up and take notice of any "drug-related parallel reaction", say doctors who have administered the drug at some point in time.

In reports trickling in over the weekend from the US, Pfizer had put out data on celecoxib linking it to a risk of heart attacks. Although the risk surfaced as Pfizer investigated an alternative use to celecoxib, the data that emerged has been unsettling for Indian companies making similar versions of the drug.

Meanwhile, doctors prescribing the drug are also exercising caution. A Mumbai-based doctor told Business Line that he had reverted to the traditional and time-tested anti-inflammatory drugs, following news linking the Cox II family of drugs to heart ailments. He had prescribed rofecoxib in the past, but had not moved to another drug in the same family since he felt that the class of drugs was under a cloud.

Rofecoxib was the largest in the Cox II family with an estimated sales of Rs 85 crore in India, for 12 months ended October. But with rofecoxib, sold under the Vioxx brandname, being recently withdrawn by Merck (the company that developed the drug) - doctors shifted back to celecoxib and valdecoxib as alternates.

The Indian Medical Association's Dr Sanjiv Malik points out that there is no need to push the panic button. Patients should be aware of the heart-related risks associated with Cox II drugs. "One should be cautious and report any possible drug-related developments to the doctor, as is the case with any drug," he said.

In India, celecoxib is a market that is de-growing, as drug companies started coming out with improved versions of the drug molecule, such as rofecoxib, valdecoxib, parecoxib and etorecoxib.

Celecoxib is an estimated Rs 13 crore market in India and Zydus Cadila, Sun, Lupin, Unichem and Cipla are some of the companies that produced the drug locally.

A Cipla official observed that since Pfizer had not withdrawn the drug. Further action would be taken as more data comes out on the issue, he said. A similar reaction came from Sun Pharma too. The company said that it would wait for more details before it decides.

The Drug Controller's office has already told drug companies to have a caution label on Cox II drugs regarding side effects, an official with the regulatory authority said.

Meanwhile, US regulatory authorities have advised minimal use or alternate therapy in the celecoxib case. And as more data on Cox II drugs comes into public domain, doctor associations stress the need to make post-marketing surveillance mandatory to catch adverse drug reactions.

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