Two European countries have removed the prescription diabetes drug Actos from further use because of increased risk of bladder cancer. After completing a three-year study, France’s agency for drug safety recently advised physicians to stop issuing new prescriptions for Actos. Germany followed France’s action after reviewing the study’s findings on the dangerous drug.
The two countries also removed the drug Competact from use, which combines another diabetes medication with Actos. Due to the possibility of additional health risks without medication, health organizations in France and Germany advised existing patients to continue taking Actos until they consult with their physicians.
History of Actos
Actos helps regulate blood sugar levels in patients with type 2 diabetes by increasing insulin sensitivity; however, it also causes severe and dangerous cardiovascular side effects. Originally approved by the U.S. Food and Drug Administration (FDA) in 1999, problems with Actos arose soon after.
Another drug in the same thiazolidinedione class, Rezulin, was removed from U.S. distribution after several reports of fatal liver disease. Later reports of congestive heart failure among those taking Actos resulted in the FDA issuing a black box warning (the most severe warning) for the drug in 2007. Revisions to prescribing information were also issued at that time. Avandia, another thiazolidinedione, has also been restricted due to increases in heart conditions.
Bladder Cancer Risk
The risk of bladder cancer appears to be higher in patients who have taken Actos for two or more years. Those taking increased doses also face higher risks for the disease. The FDA, in conjunction with U.S. health insurance company Kaiser Permanente, is conducting a 10-year study into Actos. So far, the study has found no clear connection between the drug and increases in bladder cancer.
Conflicting Information from the FDA
The FDA began reviewing Actos’ safety information in September of 2010. It has not yet issued results of the review, nor has the agency reported any intentions of initiating a recall. Even though the FDA’s 10-year study has not shown a connection to bladder cancer, the agency’s recent safety announcement acknowledged that the risk of bladder cancer reaches “statistical significance after 24 months of exposure.”[1]
The Japanese firm Takeda, which makes both Actos and Competact, states it has not yet reviewed the French health study and points to the lack of data from the FDA studies. Actos supplies more than a quarter of Takeda’s revenue.[2] The health ministry in Japan also has no current plans to recall the drug.
However, a failure on the part of the FDA to enforce safety does not excuse drug makers from responsibility. If there is sufficient evidence in Europe to ban Actos, the company should at least halt new prescription sales until its researchers can review the study findings. A ban from two European drug safety agencies is a serious action that warrants a serious response. Takeda has a duty to protect patients all over the world who take Actos.
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[1] http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm
[2] http://www.reuters.com/article/2011/06/10/us-takeda-germany-idUSTRE7591BX20110610
