Kay Van Wey
Health Canada has required Takeda Pharmaceuticals to add a new warning about Actos bladder cancer on the drug’s label. The update comes as research from a 10 year study reveals the cancer risk is high.
Actos Study Finds High Bladder Cancer Risk
Takeda Pharmaceuticals is currently conducting a 10 year study to examine the risk that a patient will develop bladder cancer while taking Actos. Although the study will not be completed until late 2012, with final results to be out by 2013, already released data shows an increased risk of bladder cancer.
Health Canada, a public health regulation body, noted in its announcement that about 7 out of every 10,000 people develop bladder cancer, while 10 out of every 10,000 Actos users develop bladder cancer. So far, the study has revealed that patients taking high doses of Actos for a year or longer have an increased risk of developing bladder cancer, although Health Canada has said that the risk is great with short-term use of Actos as well.
Actos Bladder Cancer: Canadian Doctors Have Already Stopped Prescribing Actos
Despite the label change being required on Actos in Canada, doctors in Ontario say that they have mostly stopped prescribing the drug to patients. In fact, in Ontario, Actos has been moved to the “exceptional access” list, meaning a patient cannot be prescribed Actos, unless the patient has prior approval. Doctors have cited the risk of Actos bladder cancer as the main reason for taking patients off the drug, noting that alternatives are available that are much safer.
Dr. David Juurlink, the head of Clinical Pharmacology at the University of Toronto, said that he has stopped prescribing Actos to patients because of the increased risk of bladder cancer. “I personally would not be comfortable using it as a long-term therapy because bladder cancer is . . . not something that’s reversible,” he said.
Actos Banned in France and Germany
Due to Actos’ ability to increase a patient’s risk of developing bladder cancer, regulators in both France and Germany have already pulled the drug from the market. Meanwhile, the U.S. Food and Drug Administration (FDA) is studying Actos side effects to determine if it should also take the drug off the U.S. market. While Actos is not being banned in Canada, regulators believe the new warning will sharply restrict the number of prescriptions written for Actos.
Actos Side Effects Hidden from Public
Some of the lawsuits that have already been filed in the United States against Takeda allege that Takeda knew about the Actos bladder cancer risk and tried to hide it to increase profits. A whistleblower lawsuit against the company alleges that Takeda told its employees not to report unfavorable data linking Actos to bladder cancer.
If you or a loved one developed bladder cancer while taking or after taking Actos, you may be entitled to compensation for your injuries. Call experienced Dallas Actos bladder cancer attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 for a free consultation and to learn more about your legal rights.
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