Will Actos Be Recalled Over The Bladder Cancer Risk?



Although concerns over an increased risk of bladder cancer have led some experts to call for federal regulators to issue an Actos recall, the popular type 2 diabetes drug remains on the market in the United States.

The FDA issued a drug safety communication about the risk of bladder cancer from Actos in September 2010, indicating that the federal regulatory agency was launching an investigation into whether users may face an increased risk of bladder cancer after using Actos for long periods of time.

The investigation was launched after Takeda Pharmaceuticals, the manufacturer of Actos, turned over interim data from an on-going 10-year study, which suggested that a possible link may exist between Actos and bladder cancer.

In mid 2011, Actos bladder cancer concerns increased when a study conducted by researchers in France found an increased incidence of bladder cancer among users of the medication. This led drug regulators in several European countries to remove Actos from the market, and Takeda eventually agreed to recall Actos in France.

Although consumer advocates have argued that it is necessary for Actos to be pulled from the market in the United States, a recall has not been issued. Instead, the FDA announced in August 2011 that new warning language would be added to the medication, indicating that patients who use the diabetes drug for more than a year may face an increased risk of bladder cancer.

The updated Actos warnings recommend that healthcare providers no longer use the diabetes drug in patients with active bladder cancer and exercise caution with patients who have a history of bladder cancer. These warnings were also approved for ActoPlus Met, ActoPlus Met XR and Duetact, which all contain the same active ingredient as Actos, pioglitazone.

Despite the risks, Actos remains on the market and consumers continue to take the medication because it has not been recalled. Actos warnings now advise consumers to immediately notiy their doctor if they develop blood or red color in their urine, urgent needs to urinate, pain while urinating or pain in the pack or lower abdomen, which could all be early symptoms of bladder cancer from Actos.


The Actos lawyers at Saiontz & Kirk, P.A. previously represented individuals throughout the United States who are pursuing a legal claim against Takeda Pharmaceuticals for failing to adequately warn about the potential Actos bladder cancer side effects. Lawsuits filed throughout the country allege that Takeda should have taken earlier steps to warn consumers about the risk of bladder cancer or recall Actos from the market.


Austin Kirk

Last Updated September 13, 2011

2 Comments • Add Your Comments

  • donald says:

    i take 45mgactos a day i am experiencing kindey problems severly eleveted protein levels and painful urination

    Posted on November 10, 2011 at 1:38 pm

  • MR.T.L.C. says:

    (WORD) Actos Causes A Lot More Then CANCER IT All – So Causes Heart Problems. When Actos First Started Haveing Dangerous Side-Effects./ That & Lawyers & Their Lawfirms Started Taking Plaintiffs Lawsuit Cases. IT Was Because of Heart Problems Even As Far As Heart Attacks. So All Lawyers & Your Lawfirms Don”t Forget That ACTOS Just Don”t Give A Human./ Man Or Woman (CANCER )./But ALL SO Heart – Problems As Well As… So Please Don”t For – Get When Advertising This Harmful Prescription Drug./ To Let The Plaintiffs Know… That & Lawyers & Law – Firms Are All – So Acceptting ACTOS Lawsuit CASES./ That They Are Taking Cases With People Or Plaintiiffs Who Have Had SEVERE Side – Effects From Taking The Prescriptin DRUG Actos….(CANCER) AS – Well AS Heart Problems….THANK YOU: From – MR.T.L.C. P.burg WV – – 26101 – – Date – – 01/12/2012 – – Time – – 5:14 – PM – – EST – – USA – – M-G-T-U-ALL – Done Typing – tlc

    Posted on January 12, 2012 at 5:24 pm

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