SmithKline Beecham Avandia
Executive Summary
Two cases of jaundice in the trials of the diabetes drug rosiglitazone were not considered to be drug related. The May 3 issue of "The Pink Sheet" incorrectly suggested that the cases could be related to Avandia therapy (p. 15). At FDA's advisory committee review of Avandia, SB reported that one patient had cholestatic jaundice secondary to biliary obstruction and the other had enterococcal sepsis