McKinnell: Bextra return likely

Share this article:
Pfizer 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.
Share this article:

Email Newsletters

More in News

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.