Diabetes Drug Actos Linked to Bladder Cancer

Actos is a prescription diabetes drug (generically known as pioglitazone) linked to bladder cancer by both the FDA as well as the European Medicines Agency (EMA). Actos is manufactured by Takeda Pharmaceuticals, Inc. in Japan and was approved by the FDA in 1999 to control blood sugar in adults with Type II diabetes.

Type II diabetes is the most common form of diabetes, affecting over 25 million Americans. Type II diabetes can lead to heart disease, stroke, high blood pressure, kidney disease, blindness or amputation. Actos is a pill that allows diabetic patients to improve control over blood sugar levels by making the body more sensitive to insulin.

The recent FDA Actos announcement referenced a 5-year study to further understand the increased risk of bladder cancer as well as the results of a recent Actos safety study in France.

In 2010, more than two million patients were taking Actos, according to the FDA.  The FDA reported that in one study of 193,000 patients with diabetes, the patients were on Actos for an average of two years.  Compared to never being exposed to pioglitzone, the patients who were on Actos longer than 12 months had a 40% increase in risk.

The FDA issued a safety announcement in June 2011 that there may be a connection between using Actos for more than a year and the risk of bladder cancer.  France conducted a 3-year study of Actos as a result of findings of Actos’ side effects and has banned Actos on June 10, 2011.  Germany has recommended not to start pioglitazone in new patients.  According to data from the FDA study, patients taking Actos the longest and having the highest cumulative exposure were at an increased risk of having bladder cancer, the FDA said.  “The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer,” the FDA reported in a safety announcement. The finding has prompted the FDA to add a warning to the medication label.

Sales of Actos have risen recently because it has been deemed a safer alternative to GlaxoSmithKline’s diabetes drug Avandia, which was pulled off the shelves because of potential heart risks. Because of this, last year, Actos generated $4.3 billion in sales for Takeda Pharmaceuticals, Inc. as compared to $2.9 billion in 2006.

It seems you need to choose the lesser of two evils:  one diabetes drug is known to cause serious heart risks, and the supposedly safer alternative diabetes drug is now alleged to cause bladder cancer.  Maybe one should consider following a strict, healthy diet and a good exercise regimen and stay away from these drugs all together?  Or maybe that can kill us, too?

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