Serious concerns about the safety of the diabetes drug Actos have led medical researchers and government regulators to raise warnings about a possible life-threatening link between the medication and bladder cancer. In addition, so many Actos lawsuits have been filed over this dangerous side effect that many are being consolidated in what is called a multi-district litigation presided over by a federal judge in preparation for possible settlements and jury trials.
Joining the list of critics of the medication’s safety is the nationwide consumer advocacy group Public Citizen, which has a large, well-respected medical staff which conducts independent research and testing of drugs on behalf of consumers. Public Citizen maintains a “Worst Pills, Best Pills” catalog in which it evaluates medications and Actos is listed with a “Do not Use” categorization. Here’s what Public Citizen has to say about Actos and bladder cancer:
The Food and Drug Administration (FDA) announced on Aug. 4, 2011, that the product label and Medication Guide for the type 2 diabetes drug pioglitazone (ACTOS) has been revised to warn that use of the drug for more than one year may be associated with an increased risk of bladder cancer. Pioglitazone is also available in combination with metformin (ACTOPLUS MET, ACTOPLUS MET XR) and with glimepiride (DUETACT).
Pioglitazone was approved for sale in the U.S. in July 1999 and belongs to the troubled family of antidiabetic drugs known as thiazolidinediones, or glitazones. The first member of this family, troglitazone (REZULIN), was removed from the market in 2000 because of liver toxicity. Use of the other approved glitazone, rosiglitazone (AVANDIA), has recently been severely restricted because patients treated with the drug experience an elevated risk of cardiovascular events, such as heart attack and heart failure, as well as bone fractures and visual abnormalities. None of the diabetes drugs approved by the FDA has been documented to reduce the risk of heart attack or heart failure, which are major concerns for type 2 diabetes patients.
Even before the more recent evidence of bladder cancer, Worst Pills, Best Pills News listed pioglitazone as a “Do Not Use” drug because its many risks do not outweigh its benefits, and safer drugs, such as metformin (GLUCOPHAGE) and other older diabetes drugs like glipizide (GLUCOTROL), are available. Learn more about Actos Bladder Cancer Lawsuits
While the FDA is warning of the link between Actos and bladder cancer the agency has not responded to calls that the medication be banned. The situation is different in other countries. The use of Actos and other pioglitazone medications has been suspended in France, for instance, and in Germany government regulators are recommending that the medication not be prescribed for any new patients.