Cardiovascular problems have been noted with this class of drugs along with canagliflozin. During one trial with canagliflozin there was an increased risk of stroke the individual MACE-plus component of stroke, the hazard ratio was non-significantly elevated, at 1.5 (95% CI, 0.8 - 2.6). Also the CANVAS trial, also with canagliflozin, showed some concern about cardiovascular events. Although final results from the CANVAS trial are not expected until 2015, during the first 30 days after randomization in CANVAS, there were 13 cardiovascular events in the patients receiving canagliflozin (0.45%) vs 1 in patients receiving placebo (0.07%). The hazard ratio of 6.5 was not significant because of the small number of events (95% confidence interval, 0.85 - 49.66).  Furthermore Johnson and Johnson also reported to investors that canagliflozin increased LDL cholesterol, urinary tract infections, genital mycotic infections, and was associated increased urination and episodes of hypotension and hypoglycemia. The same report did show that the drug decreased weight by a 1.9 - 3% (using the confidence intervals of the two studies sited) as well as decreased hemoglobin AIC by 0.57-0.70%, reduced both systolic and diastolic blood pressures and raised HDL cholesterol.
On July 4, 2011, the European Medicines Agency approved a paediatric investigation plan and granted both a deferral and a waiver for canagliflozin (EMEA-001030-PIP01-10) in accordance with EC Regulation No.1901/2006 of the European Parliament and of the Council.