In June 2011, the U.S. Food and Drug Administration issued a drug safety alert warning that the use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.

Actos (pioglitazone) is a prescription tablet used  to treat type 2 diabetes. It works by making cells more sensitive to insulin, which is a hormone produced by the pancreas. The body uses insulin to regulate the level and use of sugar (glucose) in the body. Making cells more sensitive to insulin allows sugar in the blood to travel more easily into the cells, enabling the body to properly regulate sugar and glucose levels in the body.

Actos is used to improve blood sugar (glucose) control in adults with type 2 diabetes. It is prescribed to patients who have trouble regulating their blood sugar with diet and exercise alone. It may be used alone or with other medicines, including insulin and metformin.

Diabetes patients prescribed Actos for over a year had a double risk of bladder cancer compared to diabetes patients not taking Actos. Moreover, even the short-term use of Actos may increase the risk of bladder cancer as much as 47%.

Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility. It is not known whether Actos will harm an unborn baby. If you are pregnant or plan to become pregnant while using Actos. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby.

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