In response to the recent criticism surrounding the world’s most popular diabetes medication, the U.S. Food and Drug Administration (FDA) has requested that Takeda Pharmaceuticals commission a study to determine the association between Actos and bladder cancer. Recent evidence suggests that the mechanism regarding the association between Actos and bladder cancer may be directly related to the pharmacodynamics of pioglitazone, the active ingredient in Actos.
As a product of Takeda Pharmaceuticals, Actos gained the approval of the FDA in 1999. After boasting the approval of the FDA, Actos quickly became a viable option for those seeking to regulate their type 2 diabetes. Upon being introduced to the U.S., Actos became the most popular diabetes medication in the world. In the last financial year alone, Actos generated $4.8 billion in sales for Takeda Pharmaceuticals.
Pioglitazone resides in a group of medications known as thiazolidinediones. As a thiazolidinediones, pioglitazone assists in increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels. Accordingly, Actos is able to utilize insulin in an efficient manor that assists in the regulation of blood sugar. In doing so, patients are able to combat the symptoms associated with type 2 diabetes.
Unfortunately, in vivo studies and numerous reports suggest a possible increased risk of Actos bladder cancer with prolonged pioglitazone therapy. Patients who implement a strict regiment of Actos for more than a year, may increase their risk of developing severe, life-threatening bladder cancer. However, the risks associated with Actos have compounded over recent years and caused healthcare officials to conduct a study to uncover the side effects of pioglitazone.
In their study, researchers included 193,099 individuals in the Kaiser Permanente Northern California diabetes registry who were 40 years of age between 1997 and 2002. Those who had already been diagnosed with bladder cancer were excluded. Patients who were administered two or more prescriptions within 6 months were treated as a time-dependent variable. Cox regression–generated hazard ratios (HRs) compared pioglitazone use with nonpioglitazone use adjusted for age, sex, race/ethnicity, diabetes medications, A1C, heart failure, household income, renal function, other bladder conditions, and smoking.
The group treated with pioglitazone comprised 30,173 patients. There were 90 cases of bladder cancer among pioglitazone users and 791 cases of bladder cancer among non-pioglitazone users. However, there was an increased risk of Actos bladder cancer in patients who used the medication for the duration of at least two years. 95 percent of the patients diagnosed with Actos bladder cancer, among the pioglitazone test subjects, were diagnosed at an early stage.
The study acknowledges a statistically significant association between Actos and bladder cancer after being exposed to pioglitazone for two more more years. Upon conclusion of their study, Takeda researchers witnessed an increased risk of bladder cancer among those with the longest periods of exposure to pioglitazone. A post hoc analysis suggests that the longer the duration of Actos treatment a patient receives, may result in an increased Actos bladder cancer risk. Due to the severity of bladder cancer, patients may contact an Actos lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Actos lawsuit.
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