Horsham, PAAs concern over Actos bladder cancer mounts, an independent drug watchdog reports that Takeda's Actos is among four drugs that have incurred sharp increases in adverse reactions.
The time frame scrutinized by the Institute for Safe Medications Practices (ISMP) covers the first quarter (Q1) of 2012 as compared with the same period a year earlier.
And while reports of Actos side effects were not the highest of the four, the result is significant nonetheless.
According to Lawyers Weekly USA (10/25/12), there were no fewer than 235 reports of Actos side effects in Q1 for 2012. Of those adverse reactions, the report did not break down which reports related to Actos and bladder cancer.
That said, the ISMP report nonetheless referenced the widely held observation that patients talking Actos for longer than two years are threatened with an increased risk of Actos bladder cancer.
Many Actos patients have filed an Actos bladder cancer lawsuit, and remain disgruntled that Actos (pioglitazone) has allegedly put them in such a position given the belief that Actos was a safer alternative for Type 2 diabetes control than the vilified Avandia. The latter drug, manufactured by GlaxoSmithKline, came under fire a few years ago for presenting increased risk for heart attack.
While Actos heart failure is also possible, the risk was thought to be lower with Actos than Avandia.
Overall, according to ISMP's Quarter Watch report, the four drugs combined represented a 30 percent increase in adverse reactions in Q1 of 2012 when compared against the same period a year ago. The drug watchdog sources statistical data used for compiling its report from the US Food and Drug Administration (FDA).
The other three drugs were Cymbalta, Tekturna, and Xarelto.
Plaintiffs in many an Actos bladder cancer lawsuit claim they were not told about the risks associated with Actos and bladder cancer. Those who were switched in droves from Avandia to Actos were assured there was less risk with Actos, especially with regard to Actos and heart failure.
Sales of Actos skyrocketed, raking in substantial profits for Japan's Takeda Pharmaceuticals Inc. As an example of how important Actos is to Takeda—in spite of the lawsuits—is a court case Takeda brought against eight competing manufacturers now making generic versions of Actos (Takeda's patent protection for pioglitazone expired this past summer).
Takeda had argued that use of Actos in combination with other diabetes treatments such as alpha glucoside inhibitors, sulphonylureas, and biguanides was covered by a combination patent until 2017, but Global Insight (10/15/12) reports the argument was rejected by the Osaka District Court.
There are various other adverse reactions tied to Actos, including Actos congestive heart failure, Actos liver problems and Actos macular edema, which affects vision. As with many other manufacturers in the pharmaceutical world, the cost of defending an Actos lawsuit—even hundreds or more—is often dwarfed by revenue derived from a drug used by a growing number of Americans for a common disease.
According to the American Diabetes Association, a staggering 25.8 million Americans suffer from diabetes in some form.
Those who have filed an Actos lawsuit are of the opinion that Actos bladder cancer, congestive heart failure or Actos edema is far more serious a health issue than the Type 2 diabetes Actos was meant to control.
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