FDA investigates diabetes drug's safety
Another widely used diabetes drug is under investigation for possible safety concerns.
The Food and Drug Administration announced Friday that it was reviewing data about the diabetes drug Actos because of concerns that it may increase the risk for bladder cancer.
The FDA stressed that at the moment there is no clear evidence that the drug increases the risk. But the agency said it was reviewing the situation.
Ironically, sales of Actos increased because of concerns about the safety of another similar drug, known as Avandia. In Avandia's case, the concern is that the drug may increase the risk for heart attacks. In July, a panel of FDA advisers issued a mixed verdict about whether Avandia should stay on the market.
Here's the FDA's statement:
The U.S. Food and Drug Administration today announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.
The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. These early results showed no overall association between Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.
At this time, the FDA's review is ongoing. The agency has not concluded that Actos increases the risk of bladder cancer.
Actos (pioglitazone) is used to control blood sugar in patients with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone). The FDA has no clinical information associating Avandia with bladder cancer in patients receiving that drug.
Patients should talk to their health care professional if they have concerns about Actos. They should not stop taking the drug unless told to do so by their health care professional.
| September 17, 2010; 2:10 PM ET
Categories: Diabetes, FDA
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