DALLAS (CNN/Money) - Merck's Vioxx, Pfizer's Celebrex and similar painkillers increase the risk of death among patients who have already survived a previous heart attack, especially when taken in high doses, according to data released Sunday at the American Heart Association conference here.
Pfizer chief executive officer Henry McKinnell said that Celebrex, an arthritis painkiller that has seen plunging sales, does not cause heart attacks and strokes and this will be reflected in its new FDA label.
The health risks surrounding arthritis painkillers have caused physicians to back away from prescribing Celebrex, rather than propping up sales for the sole remaining cox-2 inhibitor on the market, according to an analyst report.
The Food and Drug Administration asked Pfizer and other manufacturers to revise their labels to include boxed warnings of potential cardiovascular risks and gastrointestinal bleeding from certain arthritis drugs. The FDA also asked Pfizer to withdraw Bextra from the market. Following is the FDA's statement:
Pfizer Inc. agreed Thursday to change the warning labels on its arthritis drug Celebrex and pull Bextra off the market after regulators expressed concerns about the arthritis medicines' safety. Following is Pfizer's statement:
Like any government agency that has been around for almost a century, the U.S. Food and Drug Administration (FDA) has endured its share of rough patches. But "rough patch" hardly begins to describe all the bad news that has battered the agency over the past few months, from the possible suicide risks with antidepressants like Prozac, Paxil and Zoloft to the cardiac risks of pain-killers like Vioxx, Celebrex and Bextra.
While the painkillers Celebrex, Bextra, and Vioxx significantly increase the risk of cardiovascular problems, the danger is not great enough to justify taking the drugs off the market, according to an advisory committee of the Food and Drug Administration.
Pfizer Inc.'s pain drug Celebrex has a "probable increased risk" of heart attacks in higher doses but "no apparent effect" in 200 milligram doses or less, a veteran Food and Drug Administration scientist said Thursday in a written presentation.
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The Food and Drug Administration issued a warning to users of the over-the-counter pain reliever naproxen Monday after federal researchers found an increased number of heart attacks and strokes among users.
Pfizer Inc. said Friday it had no plans to pull the popular painkiller Celebrex off the market despite data showing that patients using the drug in a long-term cancer study had more than double the risk of a heart attack.