It must have been embarrassing to officials at the U.S. Food and Drug Administration when they recently issued a Drug Safety Communication in which they announced that the use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of Actos bladder cancer. The agency also announced that the warning labels on the medication would be updated to provide patients about the existence of this risk. Agency officials said that the safety alert came after they reviewed a medical research study that had been underway for five years was raising concerns about this type of long-term use and its ramifications.

The agency also said “The FDA is also aware of a recent epidemiological study conducted in France which suggest and increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not starting pioglitazone in new patients.”

For those of us whose health and choice of medications is strongly affected by what the FDA does and doesn’t do that quote raises a lot of questions. Why is the FDA lagging behind France and Germany in acting on behalf of consumer safety? Why did France and Germany have a study that the FDA didn’t have? How safe is Actos? If it has been banned in France, why not here? What did the drug’s manufacturer, Takeda Pharmaceutical Co. know about these studies and this dangerous side effect and why did they not take action to inform the consumer? The last question is one being asked in Actos lawsuits filed against Takeda by patients who have suffered these side effects.