Wednesday, September 21, 2011

FDA Actos Warnings

The drug Actos (pioglitazone hydrochloride) is used in the treatment of diabetes. Actos is used to control blood sugar levels in patients with Type 2 diabetes, which keeps the body from producing enough insulin to properly use the sugar in the bloodstream.  Type 2 diabetes can also cause the patient to become resistant to insulin.  Actos remedies this problem by making cells more sensitive to insulin, thereby making it easier for sugar to pass through the body.

The Food and Drug Administration (FDA) mandated a “Black Box” warning be added to Actos packaging in 2007.  A second FDA warning in June 2011 contained specific details of the risk of bladder cancer associated with Actos.

A recent study of 193,099 patients over a five-year period found that people who took Actos for at least 12 months or longer were 40 percent more likely to develop bladder cancer. A subsequent FDA Adverse Event report found that Actos was involved in one-fifth of all reported diagnoses of bladder cancer in diabetes drug users. At this time, however, Actos is still on the market and being prescribed by physicians. 

If you represent a client who has been diagnosed with bladder cancer after using Actos, we would welcome the opportunity to work with you on these cases.  Please contact Booth Samuels at booths@pittmandutton.com or at 1-866-515-8880.