McKinnell: Bextra return likelyPfizer chief Hank McKinnell told Reuters that the company would likely reintroduce Bextra, "because for many patients it is the best choice or the only choice." McKinnell, speaking in Atlanta at an HIV/AIDS prevention meeting, declined to offer a time frame for the drug's return to market.
Bextra was pulled April 7 at the urging of the FDA, which has questioned the Cox-2 inhibitor's efficacy relative to other painkillers and expressed concern about possible side effects, particularly the skin disease Stevens-Johnson. An FDA spokeswoman told Reuters the agency was "open to discussions" with Pfizer, but reiterated the agency's belief that the risks of the drug outweigh the benefits.
Merck has flirted with the notion of reintroducing Vioxx – most recently last week, when Merck vice president for regulatory affairs Dennis Erb told a congressional committee that the company is in talks with the FDA about a possible Vioxx return. In February, an FDA advisory committee voted 17-15 in favor of allowing Vioxx back on the market. The same panel voted 17-13, with two votes abstaining, to allow a reintroduction of Bextra, and 31-1 to allow Pfizer to continue marketing Celebrex.