Other Arthritis Drugs Questioned
The arthritis drug Vioxx may not be the only medication of its type that raises the risk of heart attack and stroke, scientists suggest in two reports released Wednesday by the New England Journal of Medicine.
That is contrary to what federal regulators said when the blockbuster pain reliever was pulled from the market last week.
Studies done five years ago when Pfizer’s 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 who led the studies, which were designed by him but funded by the drug companies.
“I believe this is a class effect,” meaning that the problem also applies to Celebrex and Pfizer’s newer, similar drug, Bextra, which remain on the market.
He called on the federal Food and Drug Administration to change its advice to patients and doctors to reflect the new safety concerns.
In a separate report also released by the medical journal, Dr. Eric Topol of the Cleveland Clinic chastises the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when hints of them first appeared years ago.
Pfizer’s medical director, Dr. Gail Cawkwell, insisted that its drugs were safe.
She called FitzGerald’s contention “an interesting theory” but said there was 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, according to IMS Health, a company that tracks drug industry trends.
Vioxx was the largest prescription drug withdrawal in history, “but had the many warning signs along the way been heeded, such a debacle could have been prevented,” Topol wrote. “Neither Merck nor the FDA fulfilled its responsibilities to the public.... I believe there should be a full congressional review.”
