The Indian Government, which banned Rofecoxib formulations and initiated a scrutiny of other Cox 2 inhibitors, may now take a re-look into the whole episode as a US FDA advisory committee opined that the COX-2 inhibitors represent a significant therapeutic advance in the perioperative management of pain. With the US committee suggesting that the withdrawal of this class of NSAIDs represents a significant step backwards in the management of pain, Indian drug authorities are once again on alert, it is learnt.

According to members of the national pharmacovigilance advisory committee, Indian experts have been keenly observing the developments with regard to the COX-2 inhibitors for the last few days. They may call for new studies on the basis of the US FDA suggestions. Interestingly, Indian ban was not based on any major ADR reports from within the country, but was based on the available evidence against the drug in the developed world.

The decision of Merck, the patent holder of the drug, to voluntarily withdraw the drug from world market also influenced the decision to ban its copycat versions in the country.

Now that a US FDA committee has opined in favour of the drug, the government may drop other COX-2 drugs from its scanner and look into the possibilities of allowing rofecoxib also in the market. Merck has also come out with a statement that the effect of roficoxib on cardiovascular cases is a class effect and is not restricted to roficoxib alone. The company says that if the advisory committee and US FDA conclude that the benefits of this class outweigh the risks in some patient populations then Merck would have to consider the implications of these new data given the unique benefits Vioxx (rofecoxib) offers. The company has also clarified that it had "not altered its position on the voluntary withdrawal of Vioxx (rofecoxib)."

Whatever be the US FDA committee's final recommendations, re-introduction of roficoxib by Merck continues to be doubtful due to the large number of litigations surrounding the drug. About 300 US patients and 100 British have gone to US courts seeking compensation from Merck due to the adverse side effects of the drug.