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Actos® Linked to Bladder Cancer

Actos (Pioglitazone HCl) which is marketed as Actos, Actoplus Met®, and Duetact®, was reported to be linked to an increased incidence of BLADDER CANCER according to the FDA Safety announcement of September 17th. While the ten year study did not show an absolute link between all taking Actos and bladder cancer, an increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos. If you believe you have been affected by Actos and you need assistance with filing a claim or want to be involved in any possible settlement, you can speak with someone now who is experienced with the tragedy of drugs that harmed when they were meant to heal. If you have had bladder cancer after taking Actos you may be a party to the Actos Lawsuit.

UPDATE 6/15/2011: An Ongoing Safety Review by FDA shows increased risk of bladder cancer for patients on Actos (pioglitazone)

The five year study showed that  an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone. An epidemilogical study in France shows and increased risk for bladder cancer as well. The FDA stated that information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. Pioglitazone containing medicines include: Actos and when combined with other drugs, Actoplus Met, Actoplus Met XR, and Duetact. For further patient information go to FDA.gov.

Along with this news, Takeda, the maker of the drug has also learned that France is pulling Actos off the market. This, too, is due to concerns over bladder cancer after an epidemiological study there.

Actos Bladder Cancer Symptoms

According to the National Cancer Institute, the symptoms of bladder cancer are very similar to those of a common bladder infection. However, if you have taken Actos, especially for longer than one year, it is important to inform your physician of  your concerns. The symptoms of bladder cancer can include: 

  • blood in the urine (or urine that appears red or rusty), more frequent urination, 
  • feeling the urge to urinate (but without results), 
  • needing to bear down in order to urinate, and 
  • pain during urination. 
However, these symptoms may be episodic, meaning that there may be no symptoms or bleeding for prolonged periods of time between episodes, so it is important to notify your doctor of even sporadic symptoms in order to avoid being lulled into a false sense of security. Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics according to the National Cancer Institute. In the FDA Data Summary. If you or a loved one has been taking Actos and has suffered from bladder cancer, assistance is available through qualified pharmaceutical attorneys.The FDA stated that in pre-approval studies, Actos (originally approved in 1999) had shown that male rats receiving dosages comparable to the clinical dose in humans developed bladder tumors. Also, in two, three year clinical studies (the PROactive study and a liver safety study) patients on Actos were shown to have a higher percentage of bladder cancer cases than those on comparative drugs.Don’t be afraid to ask questions and to seek compensation if you have been harmed. If you believe you are having bladder or other urinary symptoms now, contact your physician immediately. Ask questions and find the answers. If you have been harmed by Actos an experienced pharmaceutical attorney is available to speak with you now.