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Diabetes Drug Actos May Raise Risk for Bladder Cancer: FDA
Date:6/16/2011

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Right now, the FDA is advising doctors not to use Actos in patients with bladder cancer and to use it with caution in patients who have had bladder cancer. In addition, the agency says that "the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence."

The agency said diabetes patients should also tell their doctor if they are having symptoms of bladder cancer such as blood or red color in urine, an urgent need to urinate or pain while urinating and pain in back or lower abdomen.

In addition, patients should talk to their doctor about any concerns they have about Actos, the FDA noted.

For his part, Giangola said he is cautious when prescribing Actos. "We try to select the most insulin-resistant people to give Actos to," he said. "Those people do well with Actos."

But if Actos was taken off the market, there would be nothing to replace it, Giangola said. With Avandia essentially gone, "there is no medicine that directly influences insulin resistance the way Actos does," he said.

Giangola added that patients should not be overly concerned right now. "To jump now when we have only one medication in this class would be rash," he said. "They really ought to wait until there is more definitive evidence."

"What's worse -- the theoretical risk [of cancer] or the well-known risk of letting your blood sugar remain high? I say it's clearly [the risk of] letting your blood sugar run higher," Giangola said.

In a statement, Takeda Pharmaceuticals North America Inc., the maker of Actos, said it remains positive about the drug.

The company said in a statement that it is "confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. The company remains committed to Actos and Actos-containing medications, and to the millions of people living with the disease."

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