In a recent turn of events, Takeda Pharmaceuticals Europe Ltd. has informed the public of important safety information concerning recent allegations against their most profitable medication. Actos (pioglitazone), is an orally administered medication intended to assist in the treatment of type 2 diabetes. Despite demonstrating a significant ability to control insulin levels, recent evidence lends weight to the long-suspected link between Actos and urinary bladder cancer. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has acknowledged that Actos remains a valid treatment option for certain patients with type 2 diabetes, but there remains a small increased risk of bladder cancer in patients taking the popular medicine.
Actos, the world’s best-selling diabetes drug, gained the approval of the FDA in 1999, where it was to be sold as a medication intended for the treatment of symptoms associated with type 2 diabetes. Pioglitazone, the active ingredient found in Actos, resides in a group of popular drugs known as thiazolidinediones. It is because of pioglitazone that Actos demonstrates the ability to regulate blood sugar levels. This particular ingredient initiates a process that increases the body’s sensitivity to insulin, a natural occurring substance that assists in the regulation of blood sugar levels. In doing so, Actos may assist in the treatment of symptoms associated with type 2 diabetes.
However, recent evidence suggests that the mechanism regarding the association between Actos and urinary bladder cancer may be directly related to the pharmacodynamics of pioglitazone. After reviewing numerous sources of data, the European Medicines Agency’s Committee for Medicinal Products for Human Use has acknowledged that pioglitazone may significantly increase the risk of a patient developing urinary bladder cancer. Data collected from the Kaiser Permanente Northern California cohort study, the French CNAMTS cohort study, and a GPRD case control study indicates an increased risk of urinary bladder cancer in diabetic patients treated with pioglitazone. Subsequently, each of these clinical trials suggest that longer durations and higher cumulative doses of pioglitazone may coincide with the increased risk.
Furthermore, in a meta-analysis of these controlled clinical studies, 19 out of 12,506 patients taking pioglitazone had bladder cancer (0.15%) compared with 7 out of 10,212 patients not taking pioglitazone (0.07%). A possible risk after short term treatment cannot be excluded.
In response to these findings, Takeda Pharmaceuticals has issued a warning, informing the healthcare community of the dangers associate with taking Actos. In a letter to healthcare professionals, Dr. Charles Baum MD, the European Medical Director for Takeda Pharmaceuticals Europe Limited, issued a statement acknowledging that “new epidemiological data and a meta-analysis of randomised clinical trials have become available which indicate a small increased risk of urinary bladder cancer with pioglitazone containing products”. Due to the severity of Actos bladder cancer, patients may contact an Actos lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential lawsuit.
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