Actos Risks Cause Consumer Reports To Urge Diabetics to Avoid Drug

A consumer watchdog group is urging diabetics to avoid using either Actos or the new generic equivalent that was recently approved, saying that the health risks associated with side effects of Actos may not be worth the benefits when compared to other drugs available.  

On August 21, Consumer Reports wrote that Actos should be considered a “last resort” diabetes drug only.

The announcement came right after Mylan Pharmaceuticals received permission from the FDA last week to market generic Actos tablets in 15, 20 and 45 mg strength.

Increased risks of bladder cancer, heart failure and bone fractures all make Actos and its generic versions a drug to avoid, the report stated. The group recommended metformin as a front-line diabetes drug, to be taken either alone or with glipizide or glimepiride. Consumer Reports notes that a three month supply of those three drugs costs as little as $10.

Actos Risks Outweigh Benefits

Actos (pioglitazone) was developed by Takeda Pharmaceuticals and approved in the United States for treatment of type 2 diabetes in July 1999.  It is a once-daily pill that increases the body’s sensitivity to insulin.  Related medications that also contain the same active pharmaceutical ingredient include ActoPlus Met and Duetact.

Concerns about potential Actos risks have increased in recent years, after the related diabetes drug Avandia was heavily restricted amid concerns about heart problems and concerns surfaced about a potential link between Actos and bladder cancer.

In September 2010, the FDA reported that they were investigating the potential Actos bladder cancer risk, after interim data from an on-going study found an increased incidence of bladder tumors among users of the diabetes drug.

Last summer, a French study also identified an increased incidence of bladder cancer among users of Actos, resulting in a recall in France and Germany.

In the United States, increased Actos warnings were provided in August 2010, indicating that use of the medication for more than one year may increase the risk of bladder cancer.

Takeda Pharmaceuticals currently faces several hundred Actos product liability lawsuits filed on behalf of individuals throughout the United States who were diagnosed with bladder cancer after using Actos, alleging that the drug maker failed to provide adequate warnings about the risks associated with long-term use of the medication.  Many complaints allege that the current Actos warnings remain insufficient.

The medication also carries a black box warning about the risk of congestive heart failure, which is the strongest warning that can be placed on a prescription medication.