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New Actos Bladder Cancer Warnings Called for in Europe

Awards & recognition

After completing a review of potential Actos side effects, the European Medicines Agency (EMA) is calling for new warnings about the risk of bladder cancer to be added to the labels of the popular diabetes drug. The move comes less than a month after Actos was recalled in France and Germany over similar concerns. Here at home in the United States, a number of former users are in the process of filing Actos bladder cancer lawsuits against Takeda Pharmaceuticals for failing to warn the public about the potential risks associated with the drug.

Actos Bladder Cancer Lawsuit Update April 8, 2014: In the first U.S. trial of its kind, Takeda Pharmaceuticals and Eli Lilly were ordered to pay a total of $9 billion in punitive damages after a jury agreed that the companies failed to warn the public and medical communities about the bladder cancer risk associated with their controversial type 2 diabetes drug Actos (pioglitazone). The lawsuit claimed that Takeda and Lilly downplayed or ignored concerns about Actos’ link to bladder cancer, and mislead health authorities in order to protect profits. 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 an extended period of time, 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 22, 2011 - The EMA’s Committee for Medicinal Products for Human Use (CHMP) confirmed the bladder cancer risk, and has called for a pan-American epidemiological study to gather more data on the issue in an attempt to determine whether the risk increases with age and duration of use. The committee stated that the risk of Actos bladder cancer could be greatly reduced by patient selection and exclusion, which may involve a periodic review of the drug’s performance for each individual patient.

The U.S. Food & Drug Administration (FDA) is conducting its own review of the potential link between Actos and bladder cancer, and has required that new warnings about this risk be added to Actos labels in the United States. While the administration has decided against banning Actos in America, it has advised doctors and patients to weigh the risks vs. benefits of taking Actos carefully before beginning a regimen.

Actos Bladder Cancer

Actos (pioglitazone) is an oral diabetes drug made by Takeda Pharmaceuticals that is designed to help control insulin levels in type-II diabetics. It works to control blood sugar levels in your body by reducing insulin resistance – a condition in which the body’s cells don’t respond to the insulin that allows them to turn blood sugar into energy. Actos bladder cancer occurs when a cancerous tumor embeds itself in the bladder, an organ in the center of the lower abdomen. The disease usually starts from cells lining the bladder called transitional cells. These tumors are classified by the way they grow – papillary tumors have a wart-like appearance and are attached to a stalk, while nonpapillary tumors are less common but more invasive and typically have a worse outcome. Signs and symptoms of Actos-induced breast cancer include:

  • blood or blood clots in the urine
  • pain during urination (dysuria)
  • urinating small amounts frequently
  • frequent urinary tract infections

Symptoms that may be indicative of more advanced bladder cancer include:

  • lower back pain
  • swelling in the lower legs
  • a growth in the pelvis near the bladder (pelvic mass)
  • weight loss
  • bone pain or pain in the rectal, anal or pelvic area

Side Effects of Actos

In addition to the increased risk for bladder cancer, Actos has also been linked to the following serious side effects:

  • Congestive Heart Failure (CHF) - The link between Actos and CHF is strong enough that in 2007 the FDA increased the warnings on the drug concerning the risk.
  • heart attack
  • stroke
  • liver problems
  • fractures
  • macular edema

Actos Macular Edema

In June 2011, British researchers presented information indicating that Actos may increase the risk of macular edema in diabetics who fail to keep their blood sugar under control. The study, which was presented by researchers from the University of Nottingham, indicated that pioglitazone could increase the risk of macular edema, an extremely serious condition characterized by a swelling or thickening of the eye’s macula, the part of the eye that is responsible for detailed vision. The macula lies at the center of the retina, a thin layer of light-sensitive tissue that lines the back of the eye. When light rays are focused onto the retina, they are transmitted to the brain and interpreted as real world images. It is the macula that allows a person to pinpoint his or her vision and concentrate on fine motor activities such as reading, sewing or recognizing people’s faces. Symptoms of macular edema may include:

  • straight lines appear wavy
  • blurred central vision
  • sensitivity to light
  • pink tint to one’s vision

Have you been injured by Actos Side Effects?

If you’ve been injured by Actos side effects, you may want to consider filing a defective drug claim seeking compensatory damages to offset the cost of medical bills, lost income, lost opportunities and pain and suffering. Treating heart and liver diseases can require extensive medical care and ongoing treatment, which can interfere with a person’s career and social life. Click here to learn more about Actos from Schmidt & Clark, LLP.

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 bladder cancer cases in all 50 states.

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