EMA Recommends New Actos Bladder Cancer Warnings

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In light of convincing new scientific evidence, the European Medicines Agency (EMA) has issued a press release recommending new contraindications and warnings for Takeda’s controversial diabetes drug Actos (pioglitazone) to reduce the risk of bladder cancer in certain users. The EMA is advising healthcare providers and patients alike to carefully weigh the risks vs. benefits of taking Actos before beginning a regimen. The new recommendations come less than two months after Actos was recalled in France and Germany over similar bladder cancer concerns.

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 Lawsuit Case Evaluation: If you or a loved one has developed bladder cancer after taking Actos, 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 21, 2011 – In finalizing its review of the side effects associated with Actos, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that, despite remaining a valid treatment option for certain diabetics, pioglitazone has been linked to a small risk of bladder cancer in patients taking the drug. The committee stated that this risk could be significantly reduced by appropriate patient selection and inclusion, in addition to the requirement for a periodic review of the individual patient’s health.

The CHMP is advising physicians not to prescribe Actos to patients with a history of bladder cancer or in individuals with uninvestigated macroscopic haematuria, and to assess the bladder cancer risk prior to beginning a regimen of Actos. Taking age-related factors into consideration (especially bladder cancer, fractures and heart failure), the risks vs. rewards of taking Actos should be weighed carefully before initiating and during treatment of the elderly. Prescribing doctors should review the treatment of patients on Actos regularly to ensure that they are deriving sufficient benefits from the drug.

In its review, the CMHP analyzed all available data on the occurrence of bladder cancer in Actos users, and concluded that there is a small but significant increased risk of the disease with pioglitazone. Specifically, data from epidemiological studies point to a small increased risk of bladder cancer in patients treated for the longest durations and with the highest cumulative doses of Actos.

In a meta-analysis of randomized controlled clinical studies, 19 out of 12,506 patients taking Actos had bladder cancer (0.15%) compared with just seven out of 10,212 in patients not taking Actos (0.07%).

The EMA’s letter concludes by stating that there are some patients who cannot be adequately treated with other medications and who will benefit from taking Actos. The CMHP is advising prescribers to carefully select patients and closely monitor response to treatment. In patients responding positively to Actos, the benefits may outweigh the risks.

Actos Bladder Cancer: Signs & Symptoms

Bladder cancer begins when normal cells in the bladder begin to change and grow uncontrollably, resulting in a mass called a tumor. A tumor can be benign (noncancerous) or malignant, meaning that it can spread to other parts of the body. Potential signs and symptoms of Actos-induced bladder cancer may include:

• sensation of needing to urinate without results
• pain while urinating
• blood found in the urine
• frequent urination

The defective drug lawyers at Schmidt & Clark, LLP are currently reviewing the potential for Actos bladder cancer lawsuits nationwide. If it is proven that Takeda placed their desire for profits ahead of patient safety by failing to adequately warn about the potential risk for side effects, consumers diagnosed with bladder cancer may be able to obtain compensation through an Actos lawsuit.

Do You 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 bladder cancer lawsuits. We are handling individual litigation nationwide and currently accepting new Actos bladder cancer cases in all 50 states.