FDA Says Actos May Increase Risk of Bladder Cancer

The FDA says that the diabetes drug, Actos, may increase the risk of bladder cancer. Actos has already been pulled from French and German markets - and many predict that the FDA may follow suit.

What Is Actos?

Actos is pioglitazone sold as a single ingredient. However, pioglitazone is also sold in combination with metformin as Actoplus Met, Actoplus Met XR and with glimepiride as Duetact. Pioglitazone in general is used along with diet and exercise to improve control of blood sugar in adults with Type 2 diabetes mellitus. It is estimated that approximately 2.5 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.

Actos has been on the U.S. market since 1999 and is manufactured by the Takeda Pharmaceutical Company of Osaka Japan, although its U.S. offices are in Chicago, Illinois. Sales of Actos increased drastically after a 2007 study was released showing that GlaxoSmithKline's Avandia - then the highest selling diabetes Type 2 drug - increased the risk of heart attacks and other cardiovascular diseases. Once doctors started prescribing Actos instead of Avandia, the company's profits soared. In fact, Takeda reported $4.8 billion in Actos sales last year - approximately 27 percent of its entire revenue. However, that may soon change.

Actos Bladder Cancer Injuries

The FDA has issued several warnings about pioglitazone-containing medicines - such as Actos - in the past year. In June of 2011, Actos was taken off the market in France and Germany due to a French study involving over one million participants that showed that there was a higher incidence of Actos bladder cancer injuries with people who were taking the drug for more than a year.

As a result, the U.S. Food & Drug Administration (FDA) made the drug's label stronger; however, it didn't withdraw Actos from the U.S. market. It provided a similar warning in August 2011 in which it recommended that patients seek medical attention if they experience any sign of blood or red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination as these may be due to bladder cancer.

In addition, the FDA has said that it has received numerous adverse event reports (AER) over the past several years in which patients reported urinary tract problems or had developed bladder cancer after taking Actos.

A ten-year study, which will provide additional information on whether Actos is a defective drug, is underway; however, it is only in its fifth year. Yet, the mid-point results were enough to prompt the FDA to issue a warning and state that it intends to monitor the results of that study on an ongoing basis to determine whether or not there needs to be a black box warning - the most stringent available to the FDA - or if the drug should be withdrawn from the U.S. market altogether. Until that happens, Actos injury lawyers say that numerous Actos injury lawsuits have already been filed and that many more are expected in the near future.