The Hindu Business Line : DCGI for caution label on Cox II drugs

AS more skeletons tumble out of the cupboard, globally, on the safety of the Cox II family of anti-inflammatory drugs, Indian regulatory authorities too are not taking a chance.

The office of the Drug Controller General of India (DCGI), the regulatory authority in the country, is planning to direct drug companies to put labels on Cox II drugs cautioning use in patients with heart-related problems.

"We are considering telling drug companies to label these drugs with a safety caution for patients with cardio-vascular problems. As for new permissions on similar products, we are insisting on caution label," a top-official with the DCGI's office told Business Line.

Valdecoxib, celecoxib and more recently etoricoxib are the alternative pain-killers that are being "aggressively promoted" by drug companies globally and in India, after rofecoxib was totally pulled off the shelf over safety concerns.

However, the risk of heart-attack and strokes that triggered the global recall of rofecoxib (sold under the Vioxx brandname by Merck) has stoked another controversy over the safety of the class of Cox II drugs.

Subsequently, Pfizer - the patent holder for Bextra (valdecoxib) and Celebrex (celecoxib) - announced plans to undertake long-term cardio-vascular safety studies on both its Cox II drugs. Significantly, last week a scientist with the US regulatory authority called for scrutiny on five drugs, including Pfizer's Bextra.

While these developments are unlikely to rock the boat immediately for domestic drug manufacturers producing clones of these drugs, safety concerns will hang like a sword over their heads, point out analysts.

"Doctors may not stop prescribing these drugs for short-term use. In fact, me-too versions of etoricoxib (also from the Merck-stable) are now being launched in India!

"Questions however remain on the long-term use of these drugs. For instance, rofecoxib was a long-term drug for arthritis patients. If rofecoxib's alternatives are also suspicious, there is a problem," he said.

Pharmaco-vigilance beef-up: The DCGI's office is kicking-off a pharmaco-vigilance programe this week. Five regional centers and several medical colleges are being roped-in to tighten the reporting of drug-related adverse events.

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DCGI for caution label on Cox II drugs