DC Medical Malpractice & Patient Safety Blog

In 1999, the FDA approved the drug Actos for Type 2 diabetes. Its popularity grew substantially after its primary competitor, Avandia, was linked to increased risk of heart attack. In 2010, the drug generated $3.4 billion in sales for its manufacturer, Takeda Pharmaceuticals.

Now, Actos is under fire, too.

The drug was recalled this summer in France and Germany in the wake of increased incidents of bladder cancer among people who took Actos. Similar reports have occurred in the U.S., where the FDA has allowed the drug to remain on the market provided warning labels are added to the packaging.

Earlier this month, the first lawsuits over Actos’ alleged role in bladder cancer were filed in the U.S., and many more are expected to be forthcoming. The lawsuits charge that Takeda failed to disclose data showing an increased bladder cancer risk.

If you are a diabetic who takes this drug, notify your doctor immediately if you develop:

• blood in your urine;


• an urgent need to urinate;


• pain during urination; or


• pain in the back of lower abdomen.

In an AP story published by the Atlanta Constitution, Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, said it wasn’t clear if the bladder cancer risk is real, but that Actos and Avandia both are linked to heart risks, weight gain and possibly bone loss and fractures.

“The consensus,” he said, “already is that (Actos) should only be considered ... after patients have exhausted all other options."