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Health Canada Warns of Actos Bladder Cancer Risk

Health Canada Warns of Actos Bladder Cancer Risk

April 19, 2012 — Health Canada has issued a Public Communication to warn of the potential association between Actos and bladder cancer. Furthermore, they are announcing that the drug labels will be updated to reflect the risk of Actos bladder cancer. Several massive studies have found that Actos-users may be more than 40% more likely to develop bladder cancer.

Actos (pioglitazone) is a medication that is used by adults with Type-2 diabetes to help control blood-sugar levels. It is manufactured and sold by the Japanese-based pharmaceutical company Takeda Pharmaceutical Co. Since its approval, an alarming number of Actos users have reported severe side effects, especially bladder cancer.

After several studies linked Actos to an increased risk of bladder cancer, Health Canada made the following specific warnings:

  • Actos should not be used in patients who currently have or had bladder cancer
  • Actos should not be used by patients who have blood or a red color in their urine
  • Actos bladder cancer is more likely when a patient has certain risk factors, and a patient should be evaluated for these risk factors before starting Actos. These risk factors include: age, smoking, family history of bladder cancer, exposure to chemicals in the workplace, some cancer treatments, and radiation therapy.

Health Canada reviewed studies which showed that diabetics who take Actos are more likely to develop bladder cancer. The increased risk is still small, but it becomes more likely among patients who took high doses of Actos for at least 12 months.

Takeda Pharmaceutical Co. is currently in the midst of a 10-year post-marketing safety analysis of the drug. Although they are only at the 5-year mark, preliminary data has already shown an increased risk of bladder cancer. In the study, approximately 7 people per 10,000 who were not taking Actos developed bladder cancer. Among the Actos-users, 10 per 10,000 developed bladder cancer.

Although the increased risk is not large, bladder cancer is a potentially life-threatening disease.

Health Canada’s decision has followed regulatory action from several other countries. France and Germany have recalled Actos, after an independent French study found an increased risk of bladder cancer. The U.S. Food and Drug Administration (FDA) issued a safety communication in June of 2011 stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer.

Even with the additional safety warnings, Actos is not easily available in Canada. In Ontario, Actos was moved to a list of drugs that doctors must gain special approval before prescribing. There are many other drugs that are used to help diabetics control blood-sugar levels, but Actos is the only drug that has been associated with a higher risk of bladder cancer.

Many people who have been injured by this medication are angry because they feel that they were not warned about the risks before using Actos. If you have suffered from Actos bladder cancer or another side effect of Actos, you are not alone. Takeda is facing up to 10,000 Actos bladder cancer lawsuits both in Canada and the United States.

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