Actos and bladder cancer
The FDA has updated drug labels for Actos, usually prescribed to treat Type 2 diabetes, to state that the use of the drug for more than one year may be associated with an increased risk of bladder cancer. Actos, manufactured by Takeda, has been under FDA review since September 2010. In June 2011, the FDA issued a warning for Actos.
At the same time, in June 2011, drug regulators in France and Germany suspended the use of Actos. The ban came in the wake of a French study, conducted by the nation's health insurance agency, which examined cancer rates in approximately 155,000 people taking pioglitazone in France from 2006 to 2009, and 1.3 million other diabetics who were not receiving the agent.
The FDA began a review of Actos and cancer risk in September 2010, when the agency issued a safety announcement suggesting a potential risk with Actos. Although it concluded that there was not significant reason to remove the drug from use, the FDA reported in its data summary that "the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure."
Doctors in France and Germany have been advised to stop prescribing Actos.
Important Actos Facts
Between 2004 and 2009 more than 500,000 adverse reactions to anti-diabetic drugs were reported
Among the above cases, 138 instances of bladder cancer were identified
Of the 138 bladder cancer patients, 1/5 were taking Actos (source: Reuters)
Actos is in the same class of drugs as GlaxoSmithKline's Avandia, which has not been associated with bladder cancer but has been linked to heart risks.