The National Pharmacovigilance Advisory Committee (NPAC) has taken a serious view of the US FDA observations on the risk benefit profile of Valdecoxib and the subsequent decision of the US drug regulatory agency to ask Pfizer to voluntarily withdraw its Bextra from the market. The NPAC will invite comments from its members to decide whether a restricted use of Valdecoxib could be allowed in the country or not. Whatever be the decision, the Indian companies who are manufacturing the generic versions of the drug are sure to see sales volumes from Cox 2 drugs coming down considerably.

It was on April 7th, the US FDA asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. The reason sighted was reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra, lack of any demonstrated advantages for Bextra compared with other NSAIDs.

The US FDA has also asked manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labelling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well- described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. US FDA has also asked the manufacturers of non-prescription (OTC) NSAIDs to revise their labelling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug.

NPAC is likely to study the actions initiated by the US FDA and take an appropriate stand in the case of Cox 2 inhibitors that are available in the country.

It should be noted that India was among the first to ban roficoxib formulations after Merck, the Innovator Company, which announced the withdrawal of its Vioxx brand due to serious adverse reactions. The ban on the drug was the first decision taken by the newly constituted NPAC headed by the Director General of Health Services.

Generic versions of valdecoxib are manufactured in India by companies like Glenmark, Unichem, Nicholas Piramel, Alembic and Cipla.