Potential Peril in Arthritis Drug Feldene Cited

The National Council of Senior Citizens, a major lobbying group for the elderly, Friday labeled Feldene, the most widely prescribed arthritis medication, “a potentially dangerous drug” and urged the government to ban it nationwide.

At the same time, Public Citizen, the Ralph Nader consumer group, presented the Food and Drug Administration with evidence that the drug could be used safely only by patients under 60.

But the National Alliance of Senior Citizens, in a statement in support of Feldene, called the complaints “ill-advised and meritless.” And Pfizer Pharmaceutical, the drug’s manufacturer, told the FDA that “Feldene is not an ‘imminent hazard’ to older patients or to any patient group.”

Adverse Reactions Unexplained

The National Council, in a letter to Health and Human Services Secretary Otis R. Bowen, said that clinical studies had failed to explain “a high incidence of adverse reactions,” including gastrointestinal bleeding and ulcers, among those using Feldene, which is known generically as piroxicam.

“In examining these records, we have concluded that this drug, used by millions of senior citizens, should not have been approved for marketing in the first place,” said National Council Director William Hutton.

Public Citizen, in arguing before the FDA that Feldene be used only by patients under 60, argued that the drug builds up in the blood and that elderly persons in particular have difficulty flushing it from their systems.

‘Double-Edged Sword’

“Piroxicam represents the classic double-edged sword of convenience versus unacceptable risk for older people,” said Dr. Sidney Wolfe, representing Public Citizen.

A Pfizer spokesman told the FDA that the petition to restrict use of the drug to patients under 60 is “without merit, as the arguments are based on inappropriate, inaccurate, incomplete and misleading interpretations of data.”

“Feldene is not causing an epidemic of death,” said Pfizer spokesman Joseph Curti.

Drug’s Convenience Welcomed

According to company literature, physicians initially welcomed the drug because it is usually prescribed in a single daily 20-milligram dose to achieve relief from pain and inflammation associated with chronic arthritis.

But Public Citizen provided the FDA with internal Pfizer correspondence showing the company’s concerns over daily doses exceeding 20 milligrams.

“The selection of 20 milligrams as the usual dose for analgesia with perhaps the option of a ‘loading dose’ of 40 milligrams . . . is contrary to our own dose response data on piroxicam,” a company researcher wrote in 1982. “There is a very good chance that we will come to regret--because of the (gastrointestinal) effects--the recommendation of high doses of piroxicam for general analgesic purposes, higher than are necessary,” he added.

Company Defends Drug’s Use

Company spokesman Paul Miller told a reporter: “The recommendations made in the memo were under study and the research completed. The drug was appropriately tested and it’s properly labeled.”

The FDA will collect evidence until April 17 on Public Citizen’s petition that the drug be restricted to patients under 60 and it hopes to issue a ruling a few weeks after that.

Two related anti-inflammatory drugs, Oraflex and Maxicam, are now banned worldwide because they have been associated with gastrointestinal disorders and death.

About 4 million Americans are now taking Feldene, more than 55% of them 60 or older. The drug is marketed in 106 countries and netted Pfizer more than $4 billion in worldwide sales last year.