nsistent Labeling of Food Effect for Oral Agents across rapeutic Areas: Differences between Oncology

Download pose: Several recent oral oncology drugs were labeled for administration in fasted states despite the at food increases their bioavailability. Because this was inconsistent with the principles of oral drug ry, we hypothesized that there were inconsistencies across therapeutic areas. erimental Design: Oral agents approved by the U.S. Food and Drug Administration from January to May 2009 were included in our study. Comparison of the food labeling patterns between oncold non-oncology drugs was made using Fisher's exact test. ults: Of the 99 drugs evaluated, 34 showed significant food effects on bioavailability. When food dly enhanced bioavailability, eight out of nine non-oncology drugs were labeled “fed” to take ade of the food-drug interaction, whereas all oncology drugs (n = 3) were labeled to be administered sted” states (Fisher's exact test, P = 0.01). clusions: Drug labeling patterns with respect to food-drug interactions observed with oncology Con drugs are in contradiction with fundamental pharmacologic principles, as exemplified in the labeling of non-oncology drugs. Clin Cancer Res; 16(17); 4446–51. ©2010 AACR.