Pfizer Inc has agreed to suspend sales and marketing of Bextra in the US following FDA's order to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavourable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label.
A Pfizer release says, regarding Bextra, Pfizer's oral Cox-2 inhibitor, the FDA informed Pfizer that, in the agency's view, Bextra's cardiovascular risk could not be differentiated from other NSAIDs. However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market.
Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label. Pfizer has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40,000 patients. Pfizer also reaffirmed its commitment to conduct additional long-term clinical studies evaluating the benefits and risks of Celebrex.
Pfizer said it would work closely with the FDA to develop a guide to assist patients and their healthcare professionals in making the best decisions for treating their arthritis pain.
In addition, at the request of European regulators, Pfizer will also suspend sales of Bextra in the European Union. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions, the release added.
Meanwhile, FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labelling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.
In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labelling of the prescription NSAIDs already addresses potential skin reactions.
This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx, an FDA release said.