Pfizer this week says it has received a request from the US Securities and Exchange Commission to provide information on its once top-selling painkiller Celebrex (celecoxib) and its follow-up Bextra (valdecoxib). Sales of the former have plummeted in the wake of the global withdrawal of Merck & Co’s rival Vioxx (rofecoxib) [[02/08/05a]], [[01/10/04a]], [[21/07/05b]], while Bextra was withdrawn earlier this year [[08/04/05a]].
The disclosure was made in the US giant’s quarterly submission to the SEC: “As previously reported, we have received requests for information and documents from the US Department of Justice and a group of state attorneys general concerning our COX-2 medicines. We also are responding to a request for similar information and documents from the staff of the Securities and Exchange Commission.” In addition, Pfizer says it has also been named a defendant in a “number of product liability, consumer fraud [and] securities actions” and, in July, was hit by a suit from the State of Louisiana seeking to recover monies paid out from its Medicaid programme for Celebrex and Bextra, as well as patient damages and a bid to prevent Celebrex being marketed or resumption of the sale of Bextra in Louisiana. Bextra was withdrawn from the global market after a risk of rare but serious skin reactions were observed, pulling the plug on more than $1 billion dollars in revenue for the firm [[08/04/05a]].
Back in April, the US Food and Drug Administration said it would require boxed warnings on all painkillers, both COX-2s and non-specific anti-inflammatory agents. Cautions about the potential for serious cardiovascular and gastrointestinal risks, and recommendations that the drugs concerned be prescribed at the lowest effective dose for the shortest duration of time, were finalised in July [[08/04/05a]], [[21/07/05b]].
In December 2004, Pfizer submitted a New Drug Application to the FDA for another COX-2 inhibitor, Dynastat (parecoxib), and says, despite serious woes in the market place, it plans to continue the regulatory process for this medicine.