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Executive Summary

HRG's FELDENE "IMMINENT HAZARD" AGE RESTRICTION PETITION cites the reports of deaths among elderly users of Pfizer's nonsteroidal antiinflammatory agent as the basis for FDA action to ban use in patients over 60 years of age. The Health Research Group said in its Jan. 8 petition to HHS Secty. Otis Bowen that analysis of adverse reaction data shows that "virtually all (96) of the gastrointestinal deaths and 71% of the nonfatal reactions due to GI toxicity from Feldene which have been reported in this country occurred in persons ages 60 and older." The consumer group maintained that "because 55% of U.S. Feldene users are in this age group, we estimate that at least 1.75 mil. elderly American people now receiving this drug are at risk of developing life-threatening GI reactions." The petition states that according to a November printout from FDA's spontaneous reporting system, since the drug was introduced in 1982 "FDA has received a total of 2,621 nonfatal and 182 fatal adverse reaction reports associated with the drug's use. These figures include 687 nonfatal cases due to severe gastrointestinal toxicity and 99 deaths in which there was stomach and intestinal bleeding, ulcers, intestinal perforation, hematemesis (vomiting of blood), or melena (blood in the stool)." Feldene is particularly dangerous, HRG asserted, because it has a longer half-life than any other currently available NSAID. High levels of the drug may accumulate as it lingers in the body, presenting toxic threats to the elderly, whose kidney functions and drug clearance abilities have slowed with age, the group maintained. In addition to a label revision restricting the use of the drug to patients under 60, HRG asked FDA to require: a "Dear Dr." letter from Pfizer warning of dangers associated with use of Feldene in patients with a history of peptic ulcers or compromised kidney function; a patient package insert; and further investigation of reported adverse reactions, including phototoxicity and congestive hear failure. Current Feldene labeling includes the warning: "Peptic ulceration, perforation, and GI bleeding -- sometimes severe, and, in some instances fatal -- have been reported with patients receiving Feldene. If Feldene must be given to patients with a history of upper gastrointestinal tract disease, the patient should be under close supervision." In response to the petition, Pfizer declared that "the number of fatalities being publicized by Feldene's critics is misleading. It includes all reports of patients who died while taking the drug without any cause-and-effect relationship being established." The firm added that it is "confident that any further review will continue to support the safety of Feldene and the denial of the petition." Last week, Pfizer made a similar response to reports that the UK Cmte. of the Safety of Medicines was initiating a review of safety data for Feldene ("The Pink Sheet" Jan. 6 "In Brief"). Both HRG and Pfizer referred to NSAID adverse reaction data reveiwed last year by FDA's Arthritis Drugs Advisory Cmte. which was compiled by FDA Anti-Inflammatory Drugs Group Leader John Harter, MD ("The Pink Sheet" Oct. 29, p. 3 and May 6, P. 5). Pfizer noted that the cmte. "concluded that there was no basis for a labeling change for Feldene."

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