Public Citizen later made a FOIA request for complete, unredacted copies of the medical officers' reviews of the Bextra
NDA and in 2004 sued to obtain the information.
On its Web site, the FDA posted, "Pfizer has agreed to suspend sales and marketing of Bextra
in the US, pending further discussions with the agency.
In the wake of the Vioxx decision, prescription brands increased direct-to-consumer (DTC) advertising efforts, with Celebrex almost doubling its schedule and Mobic and Bextra
undertaking their first brand advertising efforts since the initial product launches.
In early April Pfizer pulled Bextra
from the market and the FDA announced that Celebrex and other Rx nonselective NSAIDs would carry black box health warnings on their labels.
Based on this, Vioxx and Bextra
may be associated with a higher risk of a heart attack because they are more potent inhibitors of COX-2 enzymes than Celebrex.
Many widely used drugs have been implicated, such as anti-inflammatory drugs Lodine, Voltaren, Motrin, Ibuprofen, Indocin, Advil, Naproxen, Daypro, Celebrex, Vioxx and Bextra
It's very difficult to be precise with the numbers, but we think it's clear that the reports [of skin reaction] with Bextra
are significantly higher than reports from other products," he said during the press conference.
In a surprise move, on April 7th, the Food and Drug Administration (FDA) announced it was withdrawing Bextra
(rofecoxib) from the market.
Known as a COX-2 inhibitor, Bextra
belongs to the same class of drugs as rofecoxib (Vioxx), which manufacturer Merck yanked from pharmacy shelves last September after safety risks appeared (SN: 10/30/04, p.
In April 2005, the FDA asked the manufacturer of Bextra
to withdraw this medication because the overall risk versus benefit profile for the drug was also found to be unfavorable.
The news that the FDA had withdrawn one of Pfizer's drugs, Bextra
, had adverse effects on Glaxo's share price which dropped 11p.
a dozen patients tell a different FDA advisory committee about the excruciating pain, stiffness and helplessness they had suffered until they started taking the Cox-2 pain relievers Vioxx, Celebrex and Bextra