On Alert: Diabetes Drug May Increase Bladder Cancer Risk
The Food and Drug Administration (FDA) recently released a safety alert and required a label change for Actos regarding the risk of bladder cancer for users taking the medication for more than one year or taking the highest dose. According to the FDA’s announcement, Actos can lead to a 40 percent increased risk of bladder cancer, based on a study of more than 200,000 patients with type 2 diabetes. Actos (pioglitazone) was first approved in 1999 to help lower blood sugar in patients with type 2 diabetes. Actos is part of a class of drugs known as thiazolidinediones and is designed to help control blood sugar levels by increasing the body’s sensitivity to insulin.
Since 2007, when competing diabetes drug Avandia was shown to increase risk of heart at tack and other cardio issues, Actos sales have escalated to approximately $4.3 billion in 2010 alone. The popularity of Actos is now of particular concern because the drug has been shown by several studies to increase a user’s risk of bladder cancer when taken for more than a year.
The French Medicines Agency suspended sales of Actos after reviewing a cohort study conducted by the French health insurance linking Actos use to bladder cancer. Drug regulators in Germany have also disallowed new prescriptions of Actos, pending further investigation. The European Medicines Agency (EMA) began a review of Actos in March 2011, which has not yet been concluded (at press time), but may ultimately yield similar findings and results.
Numerous lawsuits have already been filed in the United States against Actos manufacturer Takeda Pharmaceuticals, Japan’s largest drug manufacturer, and other related defendants. Be tween January and October 2010 alone, 2.3 million patients filled prescriptions for Actos, according to the FDA. Based on the 40 percent increased risk, the number of people who may have developed bladder cancer since the drug’s approval in 1999 could easily number in the thousands.
Legal experts expect that Takeda Pharmaceuticals will face many more lawsuits in the days ahead as more and more information about the link to bladder cancer is discovered.
For those still taking Actos, many medical providers are encouraging patients to consult with their doctors about the use of Actos and perhaps discussing other options available to them.
A diabetic patient should never stop taking a medication with out first getting their doctor’s approval and having a substitute therapy treatment in place.
- M. Brandon Smith is an attorney with Childers, Schlueter & Smith, LLC in Atlanta, Georgia.