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DANBURY IS DISCONTINUING PHENYLBUTAZONE AND OXYPHENBUTAZONE

Executive Summary

DANBURY IS DISCONTINUING PHENYLBUTAZONE AND OXYPHENBUTAZONE marketing as part of a settlement agreement of a product liability suit brought against the firm. Henry Schein Inc. stated in an Oct. 15 letter to plaintiff Alice Baisley that "Danbury does not intend to manufacture, market, or sell phenylbutazone or oxyphenbutazone for human use after November 1, 1986" except to fulfill existing contracts with government agencies. The company added that Henry Schein does not intend to manufacture, market or sell the products after April 1, 1987. Henry Schein is the parent company of Danbury. Hutchinson, Black, Hill & Cook, attorneys for the plaintiff, announced settlement of the suit in an Oct. 29 press release. The firm stated that Willard Baisley died Feb. 19, 1985 of toxic epidermal necrolysis, "a phenylbutazone reaction that caused him over the course of eleven days to cast off almost all his skin." In addition to a written agreement from Danbury and Schein to halt manufacture, sale and distribution of the two nonsteroidal anti-inflammatory drugs, the settlement includes payment of approximately $800,000 to Baisley's widow. In July 1985 Ciba-Geigy withdrew oxyphenbutazone (Tandearil) from the market and revised the indications for phenylbutazone (Butazolidin) to restrict its use to last resort therapy for four severe arthritic conditions ("The Pink Sheet" April 8, 1985, T&G-3). The Health Research Group petitioned FDA to remove both NSAIDs from the market under "imminent hazard" procedures in December 1983. The drugs were first marketed in 1952. Henry Schein said phenylbutazone and oxyphenbutazone represented an insignificant amount of the company's sales. The firm explained that it decided to discontinue the products because it "felt it would be wise not to present products that could give rise to significant liability."

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