Consumer Reports Gives Generic Actos a Thumbs Down

Consumer Reports is warning type 2 diabetics to stay away from generic versions of Actos (pioglitazone) that were just approved by the U.S. Food & Drug Administration (FDA). According to the publication, other diabetes drugs like metformin are a better option for most people, as they don’t carry the same risks for bladder cancer and other serious side effects seen with Actos.

As we reported last week, the FDA granted clearance to Mylan Pharmaceuticals, based in Morgantown, West Virginia, to market 15, 30, and 45 milligram pioglitazone tablets.  According to the FDA, generic versions of Actos will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.

But according to Consumer Reports, generic pioglitazone is no bargain.  Citing its association with bladder cancer and other side effects, including an increased risk of heart failure and bone fracture, Consumer Reports advises patients to use pioglitazone only a last resort.  The publication also points out that the price of the generic pioglitazone versions will probably remain close to that of brand-name Actos until other manufacturers get clearance to sell their own versions.  That won’t happen for at least six months.

Actos is among the top-selling diabetes drugs in the world. Last June, however, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer.   By that time, the French and German governments had already suspended sales of Actos in those countries because of bladder cancer concerns.  Just a month later, Takeda Pharmaceuticals officially recalled Actos in France.

Since the FDA issued its warning last June, a number of studies have confirmed that Actos can increase the likelihood that a user will suffer bladder cancer.  The growing body of evidence includes studies published just this summer in the Journal of the National Cancer Institute and the Canadian Medical Association Journal (CMAJ).  The CMAJ study found a 22% increased risk of bladder cancer when taking Actos.  The Journal of the National Cancer Institute found a three-time higher risk.

Bladder cancer is not the only serious side effect associated with Actos.  The drug’s label bears a Black Box Warning, the FDA’s most urgent safety notice, stating that it may cause or worsen congestive heart failure in some patients.  Studies have also linked Actos to fractures, and an eye disorder called diabetic macular edema.

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