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Table 1 Effects of drug warnings on the utilisation of rosiglitazone and pioglitazone in Australia

From: Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings

Drug authorities Time Warnings Adjusted for Coefficienta       95% CIb pvalue
Rosiglitazone: ARIMA (1,0,2) model
EMA1_FDA1 May 2007 Ischemic heart - −15.04 [−21.86, −8.22] <0.001 c
FDA2 Aug 2007 Label update heart related EMA1_FDA1 −2.61 [−40.41, 35.20] 0.893
EMA2 Oct 2007 Ischemic heart EMA1_FDA1, FDA2 1.94 [−95.49, 99.36] 0.969
TGA1 Dec 2007 Ischemic heart EMA1_FDA1, FDA2, EMA2 −5.25 [−38.01, 27.51] 0.837
EMA3 Jan 2008 Ischemic heart EMA1_FDA1, FDA2, EMA2, TGA1 −0.39 [−80.06, 79.28] 0.992
FDA3, TGA2, EMA4 Sep 2010 EU suspended, EMA1_FDA1, FDA2, EMA2, TGA1, EMA3 1.25 [−8.99, 11.49] 0.811
US restriction
Pioglitazone: ARIMA (1,0,1) model
FDA June 2011 Bladder cancer - −5.76 [−13.91, 2.39] 0.166
EMA, TGA July 2011 Bladder cancer - −6.57 [−14.80, 1.65] 0.117
  1. aCoefficient = Percentage change in magnitude and direction after the intervention.
  2. bCI = confidence interval.
  3. cStatistical significance at p value <0.05.
  4. TGA = Therapeutic Good Administration; EMA = European Medicines Agency; FDA = U.S. Food and Drug Administration; EU = European Union; US = United States of America.