: 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%.
: 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
However, the drug has faced bans in other countries and intense legal scrutiny due to serious health concerns. Key Safety Warnings and Bans