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Pioglitazone Products

Pioglitazone (Actos) was approved by the FDA in July 1999, and its combination products -- pioglitazone and metformin (Actoplus Met), pioglitazone and glimepiride (Duetact), and pioglitazone and metformin XR (Actoplus Met XR) -- were approved in 2005, 2006, and 2009, respectively.
The black box warning for pioglitazone products stated that these medications are not recommended for use in people with heart failure and that these drugs may cause or exacerbate heart failure symptoms. However, unlike rosiglitazone, pioglitazone is not known to cause heart attacks and has not been placed into a restricted usage program.
During studies in male rats, pioglitazone caused bladder tumors when given at normal doses. Takeda, the manufacturer of pioglitazone, is currently conducting a 10-year study to analyze the link between bladder cancer and pioglitazone use. So far, the FDA has approved a label change to pioglitazone products stating that these medications may be associated with an increased risk for bladder cancer when used for more than one year. It also states that pioglitazone should not be used in people with active bladder cancer and should be used with caution in those with a history of bladder cancer.
These warnings are based on preliminary data showing that although there is no overall additional risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer has been noted among people who were treated for the longest time and those exposed to the highest doses of the drug. The FDA is continuing their analysis of clinical trial results and has promised to update the public as more information becomes available.

Final Thoughts

Although thiazolidinediones are effective medications for lowering blood sugar levels, they have been associated with serious side effects. Pioglitazone is the thiazolidinedione that is currently considered to have the lowest risk for serious side effects. However, as more studies are completed, the risks associated with pioglitazone must be reassessed. It is important to talk to your healthcare provider about the potential risks associated with these drugs before beginning treatment.
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