While there have been significant legal and international developments, it is important to clarify that .
: In June 2011, the FDA issued a safety communication warning that using Actos for more than one year may increase the risk of bladder cancer by 40%.
Takeda Pharmaceuticals , the manufacturer, has faced thousands of lawsuits from patients alleging they were not properly warned about the risk of bladder cancer. Actos Recall in the U.S. | Girard Gibbs LLP
However, the drug has faced bans in other countries and intense legal scrutiny due to serious health concerns. Key Safety Warnings and Bans
: The FDA requires a "black box" warning—its strongest level—on the product label to alert patients to the risk of congestive heart failure . Major Legal Settlements
: Following a 2011 French study linking the drug to bladder cancer, medical authorities in France and Germany suspended or banned the use of Actos.
