April 19, 2012 — Health Canada, the top health regulatory agency in Canada, has recently published a Public Announcement to warn people about the risk of Actos bladder cancer. The health agency also announced that they will be forcing manufacturers to update the labels on all Actos products to include the new risk information. Studies involving nearly 200,000 people have found that Actos users were more than 40% more likely to have bladder cancer.
Actos (pioglitazone) is a new Type-2 diabetes medication that is sold by Takeda Pharmaceutical Co., a Japanese drug company. People who have Type-2 diabetes have a chronic metabolic disorder that makes it difficult for the body to naturally regulate blood-sugar levels. Actos is designed to treat diabetes by helping diabetics control their blood sugar levels after they eat a meal.
Unfortunately, evidence is growing linking Actos to a significantly increased risk of bladder cancer. One study involved 193,000 people with diabetes. The people who used Actos for more than one year had a 40% increased risk of bladder cancer. Studies have estimated that the risk of bladder cancer increases from 7 people per 10,000 who are not taking Actos, to 10 per 10,000 who are taking Actos.
In response to this study and others, Health Canada made the following recommendations:
- People who currently have bladder cancer, have had bladder cancer in the past, or have a family history of bladder cancer should not use Actos
- People who have blood in their urine should not use Actos
- New patients should be evaluated for serious risk factors before starting Actos. Risk factors include: age, cigarette smoking, family members who have had bladder cancer, chemical exposure at work, certain types of cancer treatments, and radiation therapy.
Health Canada’s decision to update the warnings for Actos follows regulatory action from several other massive health organizations. In 2011, after French researchers linked Actos to an increased risk of bladder cancer, France and Germany suspended sales and later recalled Actos. In June 2011, the U.S. Food and Drug Administration (FDA) published a safety communication to warn consumers that using Actos for at least 12 months could significantly increase their risk of bladder cancer. The FDA also updated the labels on Actos.
Despite the new warnings from Canada Health, diabetics in Canada are already less likely to be using the drug. For example, doctors in Ontario must gain special approval before they can prescribe Actos. The drug has been moved to a restricted list. Because there are other diabetes drugs that are not linked to bladder cancer, Actos can only be prescribed when these other drugs have failed, or if a patient has some other unique reason to use Actos.
Growing numbers of diabetics are seeking justice and compensation for their Actos injury, because they are angry that they were not adequately warned of the risks of side effects before taking this drug. Takeda may face as many as 10,000 Actos bladder cancer lawsuits. If you were injured by Actos, you are not alone. You may be entitled to compensation for your injury.
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