— The Food and Drug Administration is reviewing data suggesting a
possible link between the widely used diabetes medication Actos and bladder
said yesterday that five-year results from an ongoing study show that patients
who have taken Actos for the longest period of time had a higher risk of
bladder cancer. Bladder cancer was also more prevalent in patients who had
taken the largest cumulative dose of the drug.
manufacturer Takeda Pharmaceuticals is conducting the study, which is scheduled
to run 10 years.
agency has not concluded that Actos increases the risk of bladder cancer,’’
the agency said in a statement. Patients should continue taking Actos unless
told otherwise by their doctor, according to the agency statement.
agreed to study the risk of bladder cancer with its drug in 2003. But a
company executive said yesterday the results are too preliminary to make
any conclusions about the drug.
interim analysis raises a question, but it doesn’t answer anything,’’
said Dr. Robert Spanheimer, vice president of medical affairs at Takeda.
“We are committed to finishing the study because I think that’s
when you’re going to get the greater understanding.’’
for Actos have risen since 2007, when its chief competitor, Avandia, was
first associated with cardiovascular problems.
is considering whether to withdraw Avandia, which is marketed by British
drug maker GlaxoSmithKline. Actos and Avandia work similarly to control
blood sugar and are the only drugs in their class on the market.