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France and Germany pull Takeda's Actos over cancer link
 
 
  (Bloomberg) Takeda Pharmaceutical Co.'s best- selling drug, Actos for diabetes, will be pulled from the French market after a study showed it carried a slightly increased risk of bladder cancer, the country's drug regulator said.. The U.S. Food and Drug Administration has been monitoring Actos amid concern the drug may increase the risk of bladder cancer. An analysis of preliminary data from a 10-year study submitted by Takeda hasn't been shown to increase such a risk, the FDA said in a September safety announcement. Takeda won U.S. regulatory approval for the treatment in 1999. Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from GlaxoSmithKline Plc's Avandia. A study published last year in the American Heart Association journal, Circulation, found that Actos causes as many heart problems as Avandia.
 
(Reuters) Robert Spanheimer, vice president of medical and scientific affairs for the Japanese drugmaker, said the company has not yet had time to examine the French study and its conclusions. But he said other studies, including two ongoing prospective trials being conducted by health insurer Kaiser Permanente, have thus far shown no risk to patients of bladder cancer or other cancers from Actos.
 
FDA places more restrictions on GSK's Avandia, Pioglitazone & Bladder Cancer Risk - (05/21/11)
 
Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting - "physicians should pay careful attention to this possible risk." - (05/21/11)
 
Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone - (05/21/11)
 
Cohort Study of Pioglitazone and Cancer Incidence in Patients With Diabetes - (05/21/11)
 
pharmatimes
World News | June 10, 2011
 
Selina McKee
 
France and Germany pull Takeda's Actos over cancer link
 
French regulators have suspended the use of Takeda's diabetes drugs Actos and Competact in the country over fears of an increased risk of bladder cancer in patients taking them.
 
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The French Medicines Agency (Afssaps) made the call after receiving new data from a retrospective cohort study carried out in the country which appears to indicate a slight increased risk of bladder cancer with pioglitazone-containing medicines. Following the French move, German authorities have now informed Takeda that they will take the same measures.
 
The European Medicines Agency is currently in the midst of a probe into the safety of pioglitazone and a potential link with bladder cancer in patients with diabetes to clarify the drug's benefit-risk profile, and says it plans to discuss the evidence - including that from the French study - at a meeting later this month.
 
In the meantime, the Agency is not recommending any changes to the use of pioglitazone-based drugs.
 
The safety of Actos - which was launched in 2000 and pulls in sales of over $4 billion a year for Takeda - is also under scrutiny across the pond, where US regulators launched an investigation into its potential link with bladder cancer in September last year.
 
At the time, the US Food and Drug Administration said while early results from a long-term observational study "showed no overall association" there was an increased risk of developing the disease in patients with the longest exposure to Actos "and in those with the highest cumulative dose of the drug".
 
 
 
 
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