More troubling news for Japanese drugmaker Takeda Pharmaceutical Industries and its Type 2 diabetes drug Actos. A new Canadian study has again tied it to a risk of bladder cancer.
While the study, published Thursday in the journal BMJ, found the risk to be small--89 in 100,000 cases--it says the risk rises to 137 in 100,000 for those who have taken it for more than two years, reports U.S. News and World Report. While studies have been mixed on this question, this is not the first to draw a connection.
The FDA last year required Takeda to add a warning of possible risks, and France has made the drugmaker remove Actos from the market there out of concern that patients taking it might be at higher risk of developing cancer.
The company has said it believes in the efficacy of the drug, but it is having to face down perhaps 10,000 lawsuits trying to make the case that there is a link and that the risks were not spelled out.
One physician, Dr. Joel Zonszein, an endocrinologist at the Clinical Diabetes Center at Montefiore Medical Center in New York City, told the magazine that he thought the new study was weak and that the drug has an important place in treating some patients.
But the lead investigator on the Canadian study, which analyzed data from the U.K., says it is important that the public be told the findings, however low the risk.
"We believe physicians, patients and regulatory agencies should be aware of this association when assessing the overall risks and benefits of this therapy," says Laurent Azoulay, from the Center for Clinical Epidemiology at the Lady Davis Institute at Jewish General Hospital in Montreal.
- read the U.S. News and World Report story
- get?more?from MedPageToday
Related Articles:
Judge chooses lead lawyers in Actos litigation
Bloomberg: Takeda may face 10,000 Actos claims
French officials force Takeda to pull Actos off market
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