With rofecoxib ban turning official, all eyes are on the fate of other COX-2 drugs that are under the scanner of the National Pharmacovigilance Advisory Committee. The committee may have to reach at an early conclusion on the safety profile of these drugs as more and more reports are pouring in from various parts of the world on the risky nature of COX-2 drugs.
The latest move has come from National Institute of Health, USA that announced the halt of a large-scale cancer prevention clinical trial using Pfizer's COX-2 inhibitor celecoxib (celebrex). The reason given was predictably, heightened risk of cardiovascular events. This has also triggered debates over the safety profile of COX-2 inhibitors once again all over the world. In India too, tracking the safety profile of COX-2 inhibitors is the very first assignment taken up by the newly formed National Pharmacovigilance Advisory Committee. Though the decision to track COX-2 inhibitors in India was taken based on the rofecoxib ban and the media outcry that followed, the new findings will increase the pressure on the authorities to seriously pursue the ADR monitoring plans. Now that the committee's first recommendation on an "immediate ban of rofecoxib" has become official, pressure will be more for an aggressive ADR monitoring of other COX-2 drugs.
The available data on celecoxib is known to have suggested lot of similarities between the findings in the particular case and that of the results from a study of rofecoxib. The third drug in the category, valedecoxib has also shown increase cardiovascular risks.
While regulatory authorities like US FDA has started asking their physicians whether continued use of such drugs are appropriate, India is yet to come out with definite conclusions, medical experts complain. The ban on rofecoxib had resulted in the increase of the sales of other COX-2 drugs like etoricoxib, parecoxib and valdecoxib in India.