Entire class of painkillers to be reviewed for dangers
Published 9:00 pm Wednesday, October 6, 2004
Momentum is growing for a fresh look at the safety of Celebrex and other pain relievers as key researchers, a congressman and European regulators said they feared such drugs might raise the risk of heart problems like those blamed on the arthritis medicine Vioxx.
Heavily advertised as an arthritis drug, Vioxx was pulled from the market last week after its maker said a study showed it doubled the risk of heart attack and stroke. But the U.S. Food and Drug Administration said similar prescription drugs were safe.
On Wednesday, the European Medicines Agency in London announced that it would review all drugs of this type. And researchers writing in the New England Journal of Medicine voiced their concerns as well with such drugs as Pfizer’s popular Celebrex.
The medical journal published two reports Wednesday on its Web site – more than two weeks ahead of their planned print publication – to help inform doctors and patients considering whether to stop using the drugs.
Studies done five years ago when Celebrex and Merck &Co.’s Vioxx were approved suggest that the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist. FitzGerald led the studies, which were designed by him but funded by the drug companies.
“I believe this is a class effect,” he said, meaning that the problem also applies to Celebrex and Pfizer’s newer, similar drug, Bextra, which remain on the market.
He called on the FDA to change its advice to patients and doctors to reflect the new safety concerns.
Pfizer’s medical director, Dr. Gail Cawkwell, insisted that its drugs are safe.
“The data for Celebrex is robust and exceeds, in the length of patients in studies and in the size of studies, the data Vioxx has,” she said.
She called FitzGerald’s contention “an interesting theory,” but said there is no evidence of increased risk of heart problems among the 75 million Americans who have taken Celebrex. Long-term studies are not yet available on Bextra, which was approved in 2001.
Celebrex is the 10th most popular drug in the United States, with annual sales of $2.7 billion, up 5 percent in a year, according to IMS Health, a company that tracks drug industry trends.
