The National Pharmacovigilance Advisory Committee (NPAC) is meeting on May 2 to discuss the future of Valdecoxib formulations in India in the wake of withdrawal of Bextra, the product of Pfizer in the US, recently.

Though the committee has taken a serious view of the US FDA observations on the risk benefit profile of Valdecoxib and the subsequent decision of the US agency to ask Pfizer to withdraw "Bextra", the NPAC may not impose any immediate ban on the drug, it is learnt. The NPAC is likely to consider the fact that US remains the only country that has withdrawn the drug and would study the decisions taken by other regulatory agencies also before arriving at a conclusion. Restricted use of Valdecoxib may also be considered as an option.

It should be noted that Ranbaxy Laboratories had voluntarily discontinued the marketing of Valdecoxib with immediate effect after it was known that US FDA asked Pfizer to suspend the sales of its arthritis drug, Bextra due to unfavourable risk benefit ratio. Valdecoxib formulations are manufactured in India by companies like Glenmark, Unichem, Nicholas Piramel, Alembic and Cipla among others.

According NPAC members, there are also attempts to generate some post- marketing surveillance data on the drug from within the country itself.

It was on April 7, the US FDA asked Pfizer to voluntarily withdraw Bextra 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 had asked manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling 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 had also asked the manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug.

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

While India was among the first to ban rofecoxib formulations after Merck, the Innovator Company announced the withdrawal of its Vioxx brand due to serious adverse reactions, a similar urgency is not seen in the case of valdecoxib.