Pfizer Inc., the world’s largest drug maker, has acknowledged that a 1999 study found that elderly patients taking the drug were up to four times more likely to suffer heart problems than patients taking a placebo. But the disclousre of the study contradicts earlier statements by Pfizer over the saftey of Celebrex.

Concerns about the safety of the class of drugs called COX-2 inhibitors, including Pfizer’s Celebrex and Bextra, have increased since Vioxx was pulled from the market by Merck & Company in Sept., after a study found that it increases a patients risk of heart attack and stroke.

Pfizer said, in a press release Tuesday, that it remains confident in Celebrex and Bextra as important treatment options for athritis patients and that it has acted responsibly in sharing all appropriate data with the U.S. Food and Drug Administration.

Public Citizen, a consumer advocacy group, petitioned the FDA last week to remove Celebrex and Bextra from the market.

“The Food and Drug Administration should immediately ban the sale of Celebrex and Bextra, which put millions of people, many of them elderly, at risk of heart attack,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract.”

Worldwide sales of Celebrex topped $3.3 billion and Bextra sales totaled nearly $1.3 billion in 2004. Fourth-quarter revenues for Celebrex ($1 billion, up 24 percent) and Bextra ($417 million, up 57 percent) were strong in absolute and growth terms.

In attempt to downplay the study, Pfizer said: “this single study is only one piece of information in the vast amount of clinical trial and other data supporting the safety of Celebrex in arthritis patients.”

On February 16, an FDA advisory committee will begin a rigorous scientific evaluation of the risks and benefits of all COX-2 medicines, including Celebrex and Bextra. Pfizer said it has provided the agency with an extensive analysis of all available safety data for its COX-2 medicines and continues to cooperate fully with worldwide regulatory authorities.

(via PR Newswire)