DANBURY IS DISCONTINUING PHENYLBUTAZONE AND OXYPHENBUTAZONE
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."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth