FDA Approves Actos Bladder Cancer Warning
On the heels of the news that the US Food and Drug Administration was strengthening the required warnings about the increase in risk of contracting bladder cancer from the use of Actos, came news that a new Actos lawsuit was being filed in several states alleging the manufacturer of the drug, Takeda, concealed the risks. Concern about a link between Actos and bladder cancer has led to the new FDA requirements for the packaging of Actos, including a black box warning and enhanced warning of increased bladder cancer risk on the drug’s interior packaging.
The FDA’s warning about Actos bladder cancer is based on results that have come to light from several souces in the US and Europe. According to the information released by FDA, the use of pioglitazone -the generic name of Actos- for more than one year may be associated with an increased risk of bladder cancer. As of August 2011, the FDA has required stronger warning labels, alerting patients to the potential risk of bladder cancer in long-term use of Actos.
The black box warning is the FDA’s strongest warning label. The warning on Actos is intended to inform patients who are being treated with the drug of the increased risk of developing bladder cancer that is associated with Actos. As indicated in the FDA study, diabetes patients taking Actos for two or more years were found to have a 40% higher risk of developing bladder cancer.
The updated labels were requested after an interim analysis of the 5 year results of a 10-year FDA study on Actos found that there was an increased risk of bladder cancer in patients who had the longest exposure to pioglitazone and those who had the highest cumulative dose of the medicine. France stopped the use of Actos after a study performed by the French National Health Insurance Plan. The French study showed that there was a statistically significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents. The use of Actos has also been banned in new patients in Germany. The EMA’s Committee for Medicinal Products for Human Use has started a European review of pioglitazone containing medicines in March 2011 to investigate the signal of a possible increased risk of bladder cancer with pioglitazone. Actos has not yet been banned in Europe.
The FDA has not issued a full ban on Actos, recommending instead that the drug not be used in patients who have active bladder cancer and be used with caution in patients who have a prior history of bladder cancer. The FDA’s release of a drug safety communication about Actos outlines the increased risk for bladder cancer in diabetes patients who have taken or are currently taking Actos.
Lawsuits are already pending in several states and federal court as a result of these findings. Class action lawsuits are being prepared in Louisiana and California as a result of the increased risk of developing or exacerbating bladder cancer that is presented by Actos.