The Department of Health and Human Services was urged yesterday to ban the use of Feldene, Pfizer Inc.'s anti-arthritis drug, by persons 60 and older.
The Public Citizen Health Research Group (HRG) petitioned HHS Secretary Otis R. Bowen to declare Feldene an imminent hazard to the public health of the elderly and cited 2,803 adverse reactions -- including 182 deaths -- associated with its use in the United States. The reactions included 687 nonfatal cases of severe gastrointestinal (GI) toxicity and 99 deaths in which there was stomach and intestinal bleeding, ulcers, intestinal perforation and other disorders.
Dr. Roger Sachs, a vice president of Pfizer Pharmaceuticals, said Pfizer gave "all data on Feldene" to the Food and Drug Administration. "A comprehensive review" completed by the the FDA and its arthritis advisory committee last April "confirmed that Feldene is a safe and effective medication for all arthritis patients, including the elderly," he said.
Sachs said the adverse reactions, viewed in the context of 2.5 million patient-days of global usage, "occur at the same rate or a lower rate than with other nonsteroidal agents. The number of fatalities being publicized . . . is misleading. It includes all reports of patients who died while taking the drug without any cause-and-effect relationship being established. We are confident that any further review will continue to support the safety of Feldene and the denial of the petition."
Pfizer introduced piroxicam, the drug's generic version, in several countries in 1979 and in the United States in April 1982. Eli Lilly & Co. launched Oraflex, a rival once-a-day anti-inflammatory drug, at about the same time in this country, but withdrew it in August 1982 after numerous elderly users died.
U.S. sales of Feldene reached $226 million in 1984. About 3.2 million Americans -- at least 1.75 million of them elderly -- had a Feldene prescription filled for the first time in 1984, HRG said. In addition, pharmacists refilled about 4.8 million refill prescriptions. Worldwide, Feldene is the most widely sold drug of its type, with sales reportedly exceeding $400 million.
Among the nonsteroidal anti-inflammatory drugs (NSAIDs) most often prescribed in this country -- Upjohn's Motrin, Syntex's Naprosyn, Merck's Indomethacin and aspirin -- Feldene alone features once-a-day dosage. But this convenience is double-edged, said HRG, a nonprofit group directed by Dr. Sidney M. Wolfe and founded by Ralph Nader.
Surveys conducted by the FDA and drug regulatory agencies elsewhere "indicate that GI toxicity is more common and severe with Feldene than with similar arthritis drugs -- particularly in elderly patients," Wolfe and science researcher Pauline Sobel told Bowen.
HRG's explanation is "that Feldene lingers in the body several times longer than comparable drugs" and that this is a particular hazard for geriatric patients, in whom kidney efficiency commonly declines.
The petition cited Canadian studies showing that the elderly excrete piroxicam more slowly than do the young, whether the drug is taken only once or every day for six weeks. This correlation is "a cause for great concern" because, with advancing age, "High levels of the drug may accumulate and predispose [elderly users] to potentially fatal adverse reactions," HRG said.