Pfizer suspended sales of Bextra in April after U.S. and European regulators said the risk of serious side effects from the drug, including a potentially fatal skin allergy, outweighed benefits.
The Food and Drug Administration asked Pfizer to pull Bextra from the U.S. market, claiming provided no added advantage as a painkiller and could cause a potentially life-threatening condition called Stevens-Johnson syndrome.
The allergic skin reaction usually begins as a blistering of the mouth and lips and can spread to the rest of the body.
The agency is open to discussions with Pfizer according to the FDA, but it has stated that it believes Bextra's risks outweigh its benefits.
In an April 6 memo outlining the FDA's views on COX-2 and other painkillers, agency officials said they were open to allowing "limited access" to Bextra in clinical trials if Pfizer proposed new studies.
The agency would reassess the drug if the studies showed an advantage over other arthritis medicines, the memo said.
Pfizer, which disagrees with the regulatory decisions on Bextra, has been exploring options with regulators under which it might be allowed to resume sales of the drug. Bextra had sales of $1.3 billion in 2004.
Analysts said Bextra would face an uphill battle even if it were cleared for a comeback.<>Eeven if it came back it would not be commercially successful because of its perceived risks, in my opinion.
This information is culled from various sources, including Reuters, AP, and yahoo.com.