Takeda Recalls Actos in France over Bladder Cancer Side Effects

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Breaking News: Bowing to widespread concerns regarding bladder cancer side effects in Actos users, Takeda Pharmaceuticals has agreed to recall its best-selling diabetes drug from the market in France. The move comes less than a month after French regulators suspended sales of Actos in response to a growing number of reports of bladder cancer in certain users. Actos is Takeda’s best-selling drug, with sales of nearly $3.5 billion in 2010 alone.

Actos Update 4/27/12: The Canadian province of Ontario is limiting patient access to Actos due to the risk of bladder cancer that has become increasingly linked to the drug. The Ontario Public Drug (OPD) program has announced that it is removing Actos from its list of approved drugs, which means that in the future patients will need to go through special steps in order to obtain the medication. Click here to learn more.

Actos Bladder Cancer Update 4/24/12: Last week, Health Canada announced that it was requiring new bladder cancer warnings to be added to labels of Actos. The move came following a safety review of the drug that was launched last year, when the U.S. Food & Drug Administration (FDA) required similar warnings for Actos in this country. Click here to learn more.

Free Actos Bladder Cancer Case Evaluation: If you or a loved one has been diagnosed with bladder cancer after taking Actos for a year or more, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

July 13, 2011 – Takeda’s decision to recall Actos in France comes only after being heavily pressured by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS). A review of insurance data on 1.5 million French citizens identified a significant increase in bladder cancer reports among Actos users. A related medication Campetact – which is sold in America as Actoplus Met – will also be recalled in France. Despite these actions, there is no indication that these drugs will be recalled here at home in the U.S.

Actos is an FDA-approved oral prescription medication designed to control blood sugar levels in patients with type-2 diabetes. It is from the same class of drugs as Avandia (rosiglitazone), which has recently been linked to an increased risk of heart attacks and heart-related death. In addition to the heightened risk of bladder cancer, Actos side effects have been reported to include:

• congestive heart failure (CHF)
• heart attack
• stroke
• liver problems
• bone fractures
• macular edema

Actos Bladder Cancer Warnings

In June 2011, the U.S. Food & Drug Administration (FDA) issued a press release announcing that it was requiring new bladder cancer warnings to be added to Actos labels, highlighting an increased risk in patients who took the drug for a year or longer. All medications containing pioglitazone – the active ingredient in Actos – will carry the new warning. Drugs in this class include:

• Actoplus Met
• ActoplusMet RX
• Duetact
• Avandia
• Avandaryl
• Avandame

The administration first announced a possible connection between Actos and bladder cancer in September 2010, after data from a decade-long study suggested the increased risk may be directly proportional to the length of time the drug is taken. Last May, another study conducted by Italian researchers found an abnormally high number of Actos bladder cancer reports in the FDA’s Adverse Event Reporting System records.

Actos & Macular Edema

Last month, a study presented by researchers from the University of Nottingham at the American Diabetes Association’s 2011 Annual Meeting indicated that Actos and Avandia could increase the risk of macular edema, an extremely serious condition that can lead to blindness. The study involved more than 100,000 diabetic patients living in the U.K., and found that 1.3% of those who took either Actos or Avandia developed macular edema after one year of use, compared to just 0.2% of those from the control group who took no such medications. Taking these figures into consideration, the risk of diabetic macular edema increased three to six times among people who used Actos or Avandia. Signs and symptoms of Actos-induced macular edema may include:

• straight lines appearing wavy
• blurred central vision
• sensitivity to light
• pink tint to vision

Actos Congestive Heart Failure

In 2007, the FDA announced that Takeda and other manufacturers of diabetes drugs in the same class as Actos were required to add stronger warnings about the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information was ordered to be included in the form of a “boxed” warning – the strongest form of warning allowed by law. The new label information emphasizes that that drugs containing pioglitazone – Actos, Avandia, Avandaryl, Avandamet and Duetact – may cause or worsen heart failure in certain high risk patients.

Do I have an Actos Bladder Cancer Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new Actos bladder cancer cases in all 50 states.