Up to 182 Deaths Attributed to Feldene : Ban on Arthritis Drug Urged for Those Over 60

A Washington consumer group, citing reports of as many as 182 deaths among patients taking Feldene, the nation’s fourth most popular arthritis drug, called Wednesday for an immediate ban on its use by people over 60.

A petition filed with the secretary of health and human services by the Public Citizen Health Research Group said there had been 2,621 reported adverse reactions to Feldene. Of those, 687 involved serious gastrointestinal complications such as ulcers, intestinal perforation, bleeding and vomiting blood. The petition contended that Feldene has been responsible for at least 99 fatalities from gastrointestinal bleeding alone.

The health research group complaint said Feldene is used by 3.2 million Americans, of whom 1.75 million are over 60. The complaint said 96% of the gastrointestinal deaths related to Feldene and 71% of the non-fatal side effects were in patients over 60.

‘Imminent Hazard’

The petition urged use of special provisions in federal drug laws that permit the Food and Drug Administration to make a declaration that a drug is an “imminent hazard” and immediately restrict its use.

The FDA said it “welcomes” the petition by Dr. Sidney Wolfe, director of the consumer group. However, the FDA said its most recent official advisory committee recommendation was that Feldene may be used in all age categories, even though it carries some risk of gastrointestinal bleeding and death.

In New York, Pfizer Inc., Feldene’s manufacturer, said “any further review will continue to support the safety of Feldene and denial of this petition.”

No Final Proof

Dr. Roger Sachs, Pfizer’s vice president for regulatory affairs and clinical safety, said the proportion of gastrointestinal problems is no higher for Feldene than it is for similar drugs in its class. Sachs also contended there was no final proof that Feldene itself--as opposed to some unrelated complication--had caused the deaths attributed to it.

The complaint made Feldene the fourth arthritis drug in a group called non-steroidal anti-inflammatories to have safety questions raised about it. Two of the drugs--Zomax and Oraflex--have been withdrawn or banned from sale in the U.S. Another drug, Butazoladin, has been subjected to major restrictions in its use.