Group Says Actos Bladder Cancer Risk More Reason for “Do Not Use” Warning

Public Citizen, a prominent consumer watchdog group, has indicate that the risk of bladder cancer from Actos is further proof that the diabetes drug needs to be removed from the market, and reinforces their earlier decision to place the drug on their “Do Not Use” list.

The group has listed Actos, a Takeda Pharmaceuticals diabetes drug, as a drug that consumers should avoid for some time, as Public Citizen believes that the risk of Actos side effects outweigh potential health benefits. In addition, the group has suggested that several safer drugs are available, such as metformin and glipizide.

Actos (pioglitazone) is a member of a family of drugs called thiazolidinediones, or glitazones, which have been linked to a number of health problems and have not been shown to reduce the risk of a heart attack or heart failure for diabetics, which are the main goals of treatment. The family of medications also includes Avandia, which was severely restricted last year due to an increased risk of heart attacks, and Rezulin, which was removed from the market in 2000 due to liver toxicity.

In the latest issue of Public Citizen’s “Worst Pills, Best Pills” newsletter, the group reiterated calls for an Actos recall following new label warnings that indicate use of Actos for more than one year may be associated with an increased risk of bladder cancer.

FDA officials began reviewing the potential Actos bladder cancer risk in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug.

In June, France required a removed Actos from the market after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.

In the United States, new Actos cancer warnings were approved by the FDA in August 2011, recommending that patients contact their doctor if they see blood in their urine or experience symptoms like new or worsening urinary urgency or pain when urinating, as these may be signs of bladder cancer from Actos.

Although the FDA has allowed Actos to remain on the market, Public Citizen is urging consumers taking Actos, ActoPlus Met or Duetact, which all contain pioglitazone, to contact their doctors about switching to equally effective and safer drugs for type 2 diabetes.

In recent months, a growing number of individuals throughout the U.S. are pursuing an Actos lawsuit against Takeda, alleging that the drug maker failed to provide adequate warnings for consumers or the medical community, despite reason to know about the link between Actos and bladder cancer.

The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear arguments in December over whether the federal Actos litigation should be consolidated for pretrial proceedings. Some estimates suggest that more than 1,000 cases will ultimately be filed over bladder cancer from Actos in federal district courts throughout the country.