Pfizer chief executive, Hank McKinnell, believes the firm’s suspended arthritis agent Bextra (valdecoxib) could return to the market. In an interview with Reuters, Mr McKinnell said its drug was needed, adding: “For many patients it is the best choice or the only choice.”
Bextra was withdrawn from the market in April after regulators deemed the compound’s side effects to outweigh its benefits [[08/04/05a]]. Despite adding a warning to the label in 2004 [[10/12/04c]], the US Food and Drug Administration asked the drug behemoth to suspend sales of Bextra after evaluating the risk of developing rare but potentially fatal skin reactions. At the time, Pfizer said that it “respectfully disagreed” with the FDA’s conclusion, but that it would comply with the request and would explore its options with a view to returning the product to market. However, reports Reuters, an FDA spokesperson has rebuffed the idea, saying that although the agency “is open to discussions,” it continues “to believe Bextra’s risks outweigh its benefits.”
Bextra is a member of the same class of compounds as Merck & Co’s now-withdrawn Vioxx (rofecoxib), which was pulled last year after evidence pointed to an increased risk of heart attack and stroke [[01/10/04a]]. It reaped sales of $1.3 billion dollars in 2004.
In response to the reports, Pfizer yesterday issued a statement saying: “As previously communicated, Pfizer has suspended sales of Bextra pending further discussions with the US Food and Drug Administration. Pfizer continues to believe that Bextra could be an important treatment option for certain patient populations. In the future, the company plans to discuss options with the FDA under which Bextra might be made available to those patients.”