The Food and Drug Administration (FDA) recently reviewed partial findings from a 10-year study by the manufacturer that determined Actos (pioglitazone hydrochloride), the prescription medication used to improve blood sugar level for those with type 2 diabetes, carries with it an increased risk of bladder cancer. The findings of the epidemiological study of 193,099 diabetic patients, which were released this past June, have created enough worry that Actos has already been banned in France and Germany because of its risk. The FDA is now advising doctors to warn patients of the risk when prescribing the medication. Further, the FDA noted in its June 15, 2011 Drug Safety Communication concerning risks of bladder cancer from use of pioglitazone:
"[c]ompared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk"
Actos belongs to a class of drug known as thiazolidinedione (TZD), which now has two popular drugs associated with severe harmful side effects. Last year, concerns that the other drug in the class, Avandia, may increase the risk of heart attack prompted the FDA to restrict use of the drug. Actos has in some cases been prescribed instead of Avandia because of these concerns. Unfortunately, a recent study published in the American Heart Association journal Circulation found that Actos may also increase the risk of heart disease by as much as 4 percent.
Pharmaceutical Class Action
Takeda Pharmaceuticals and Eli Lilly & Co., the manufacturers of Actos, are facing a class action lawsuit for a failure to warn consumers of the increased risks. In 2009, Eli Lilly & Co. pled guilty to illegally marketing Zyprexa, an anti-psychotic drug. Ultimately the company paid out $1.42 billion to settle the pharmaceutical class action.
Takeda Pharmaceuticals has been the sole marketer of Actos since 2006, when Eli Lilly lost its rights to the drug. Actos has been one of the most-prescribed drugs in the U.S., with sales in 2010 exceeding 2.6 billion dollars.
Take Action
Always speak to your prescribing physician before discontinuing the use of any medication. If you have symptoms of bladder cancer, such as blood in the urine, pain or burning during urination or a change in bladder habits, speak to a doctor immediately.
Actos is also marketed under the names "Actoplus Met", "Actoplus Met XR" and "Duetact". Anyone who took or is taking Actos or another of these drugs should contact a personal injury lawyer to discuss potential involvement in the class action suit, which may bring significant compensation for injuries and wrongful death.
email this page
print page