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Generic Actos Gets FDA OK, Despite Bladder Cancer Risk

Aug 20, 2012 | Parker Waichman LLP

The Food and Drug Administration has approved the first generic formulation of the type 2 diabetes drug Actos, making the popular and controversial drug available at a lower price and likely to be taken by more and more diabetics.

The approval of pioglitazone hydrochloride (marketed by Takeda Pharmaceuticals as Actos) comes at a time when the brand-name manufacturer is facing increased litigation over the drug’s link to bladder cancer. The first generic form of Actos will be manufactured by Mylan Pharmaceuticals and marketed in 15-, 30-, and 45-milligram doses.

Actos works by regulating blood sugar levels. It belongs to a class of drugs known as thiazolidinediones (TZDs), a class that has been marked by a checkered past, including two previous diabetes medications that have either been pulled from the market (Rezulin) or severely restricted (Avandia) because of links to life-threatening side effects.

As it approves a generic formulation of Actos, the FDA is also reissuing the safety guidelines for prescribing the drug as many more will likely turn to it that it’s available less expensively. The agency notes the drug’s common side effects: upper respiratory tract infection, headache, muscle pain, sore throat, and sinus infection. It also lists the Black Box warnings the drug has been labeled with since its initial approval, such as a link to heart failure, bone fractures, and liver disease.

Most recently, as use of Actos has risen in the virtual absence of a competitive TZD drug like Avandia, more attention has been given to the drug’s link to life-threatening bladder cancer. After months of speculation, the FDA recently warned last year that long-term or high-dosage use of Actos in the treatment of Type 2 diabetes could greatly increase a person’s risk of developing bladder cancer. Taking the drug for as long as five years could create a two- or three-fold increased risk of bladder cancer. There have also been cases of people taking Actos for less than a year, at high doses, who have developed bladder cancer.

Most at risk of developing bladder cancer while taking Actos, according to recent studies, are elderly men over the age of 60.

When the FDA released its own study that showed taking Actos caused an increased risk of bladder cancer, it caused two foreign governments, France and Germany, to ban the drug outright.

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