WEDNESDAY, March 30, 2016 (HealthDay News) — More evidence linking the diabetes drug Actos to an increased risk of bladder cancer has surfaced in a new study that also finds the risk rises with increased use. The PROspective pioglitAzone Clinical Trial In macroVascular Events trial showed an imbalance in bladder cancer between users of pioglitazone and placebo (14 versus six cases, p = 0.069). Pioglitazone and rosiglitazone belong to a class of drugs called thiazolidinediones that help to control blood sugar levels in patients with type 2 diabetes. Or is the link related to the medications used to treat diabetes, including insulin? (2011) Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. This first-year increased bladder cancer risk was limited to those with the fewest physician visits 2 years before the index date (≤12 visits, aHR 2.14 [1.29–3.55], P = 0.003).
Lawsuits filed by Kelley & Ferraro allege, among other things, that Actos was defectively designed and unreasonably dangerous and that the manufacturers and distributors of Actos failed to adequately warn the public of these known dangers. Increasing duration of pioglitazone use and increasing cumulative dose were not associated with risk of bladder cancer (>48 months of pioglitazone use, adjusted hazard ratio 0.86 (0.44 to 1.66); >40 000 mg cumulative dose, 0.65 (0.33 to 1.26) in the nearest match cohort). FDA initially declined dapagliflozin approval in 2012.