Last month, Health Canada became the latest national drug regulator to issue a warning regarding the connection Actos and bladder cancer. The agency told consumers about interim results from a 10-year-study that indicated that patients taking Actos for a year or more had a significant increase in bladder cancer risk. Takeda Pharmaceuticals, the maker of Actos, agreed to update the Actos label in Canada to reflect these new risk findings.
In June 2011 the FDA issued a safety alert based on new information on the increased risk of bladder cancer in patients who take Actos. A warning about the increased bladder cancer risk was soon added to the Actos label in the United States. France and Germany suspended Actos sales last summer. Actos was recalled from the French market in July 2011.
Takeda could face as many as 10,000 Actos bladder cancer lawsuits in the U.S.