The National Pharmacovigilance Advisory Committee (NPAC) has recommended a ban on valdecoxib formulations in the country. The NPAC meeting held here on May 2 took serious note of the US FDA observations on the risk benefit profile of valdecoxib and wanted the drug to be withdrawn from Indian markets. The central government is expected to accept the NPAC recommendation and notify a ban on the drug.
This is the second COX2 inhibitor to be withdrawn from Indian market, the first being rofecoxib formulations.
Currently, USA is the other country where "Bextra", the patented version of Valdecoxib manufactured by Pfizer, has been withdrawn due to official warning.
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 (valdecoxib), due to unfavourable risk benefit ratio. Valdecoxib formulations are manufactured in India by companies like Glenmark, Unichem, Nicholas Piramel, Alembic and Cipla among others.
It was on April 7th, the US FDA asked Pfizer, Inc. 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 (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 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.