Actos Cancer Risk Timeline

Austin Kirk

By Austin Kirk
Posted September 14, 2011


A large number of people with diabetes turned to Actos after concerns arose in 2007 about the potential risk of heart problems with Avandia, a rival medication used for treatment of type 2 diabetes. However, recent research suggests that Actos side effects may actually increase the risk of bladder cancer the longer the medication is used.

>>MORE INFORMATION: Actos Cancer Lawsuit Evaluations

Evidence suggests that Takeda Pharmaceuticals knew or should have known about the Actos cancer risk for some time, but failed to adequately research the medication or warn about the potential problems. The timeline outlined below provides a summary of the sequence of events that have led many to call for an Actos recall to be issued:

Prior to Approval — A two-year study conducted on rats found that drug induced tumors from Actos were observed in male rats receiving doses that produced blood drug levels equivalent to those resulting from a clinical dose.

July 1999 — Actos is approved as a once-a-day type 2 diabetes treatment by the FDA.

2005 — Results of the PROactive Study (PROspective PioglitAzone Clinical Trial in Macro Vascular Events) demonstrated a higher percentage of bladder cancer cases with Actos use than in competitors’ drugs following three years of research. That information was not included when the the study’s findings were published.

September 17, 2010 — The preliminary findings from a 10-year epidemiological study caused the FDA to announce that it was launching an investigation into the potential Actos bladder cancer risk associated with use of the medication for more than two years.

April 2011 — The American Diabetes Association published an analysis of the FDA’s adverse event reporting system (AERS) which found a high rate of reports involving bladder cancer with Actos use between 2004 and 2009. The report, “Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting,” called for constant epidemiological surveillance.

June 9, 2011 — France announces that it is suspending use of Actos after a study by French insurers find a statistically significant increased risk in bladder cancer among men who use Actos. Germany makes a similar decision.

June 15, 2011 — The FDA issues an Actos bladder cancer warning, saying that use of the drug for more than one year could be associated with an increased risk of tumors. The federal drug regulator agency ordered new information about the potential link between Actos and cancer of the bladder be added to the Warnings and Precautions section of the drug label. When compared with individuals who had never used the medication, the FDA indicated that Actos use for 12 months was associated a 40% increase in the risk of bladder cancer.

July 12, 2011 — Takeda Pharmaceuticals agrees to recall Actos in France.

July 21, 2011 — The European Medicines Agency decides not to remove Actos from the market, but recommends strict surveillance and screening of users. The EMA’s Committee for Medicinal Products for Human Use (CHMP) indicated that the risk of cancer from Actos could be reduced by appropriate patient selection and exclusion, which would include a requirement for a three to six-month review of the drug’s performance for each patient.

August 4, 2011 — The FDA approved new warning label information about the potenital bladder cancer side effects of Actos, ActoPlus Met and Duetact, which all contain the active pharmaceutical ingredient pioglitazone. The new warnings in the United States now urge patients to immediately contact their doctor if they experience Actos bladder cancer symptoms, which could include blood in their urine, urgent need to urinate, pain while urinating, back pain or lower abdomen pain.


Based on mounting evidence, it appears that Takeda Pharmaceuticals knew or should have known about the potential Actos cancer risk and failed to take steps to make sure that consumers and the medical community were aware of the potential side effects. As a result of this decision to place their desire for profits before consumer safety, individuals diagnosed with bladder cancer may be entitled to compensation through an Actos lawsuit.

All cases are being pursued by our Actos attorneys under a contingency fee agreement, which means that there are no fees unless we win. To review a potential claim for yourself, a friend or famil member, request a free consultation and claim evaluation.

4 Comments • Add Your Comments

  • SHIRLEY says:


    Posted on November 19, 2011 at 4:37 pm

  • wanda says:

    I’ve taken actos about 4 years,now I take glipizide 5 mg but I also been diagnosed with stage 3 kidney desease,and in the past 6 months I fine it so hard to hold my water and I can’t get a good nights sleep for urinating every two hours. I see an urologist , he gives me furosemide and sees me about every 3 months but no one has said anything about having my bladder checked. Now I’m worried.

    Posted on November 17, 2014 at 1:12 pm

  • Carmen says:

    If my dad developed bladder cancer but ultimately passed due to mesothelioma do we his adult children have a case? My mom has passed.

    Posted on January 25, 2017 at 8:52 pm

  • Joyce says:

    I started taking Actos 30 mg tablets when it first came on the market in 1999. In 2012 I was diagnosed with Bladder Cancer. I have been suffering every since then, physically, emotionally, financially. I am sincerely depressed and I just want to give up and die. I have to take BCG treatments because it is a reoccurring and aggressive cancer. It has been 5 years of living in pure hell for me. my husband abandoned me, I contracted MRSA 3 times from the emergency surgery to remove a tumor and the hospital did and will not take responsibility for pain and suffering. I lost 2 jobs because I was not able to work and was evicted from my apartment and had to sleep in my car for a week.

    Posted on April 21, 2017 at 2:32 pm

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