Preliminary safety data relating to bladder cancer risk of Takeda's Actos under review by US FDA; Actelion subpoenaed over Tracleer marketing
The US Food and Drug Administration says it has begun a safety review of Japanese drug major Takeda Pharmaceutical’s (TSE: 4502) diabetes type 2 drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study funded by the company designed to evaluate the risk of bladder cancer associated with use of this drug.
The preliminary results are based on five-year data from an ongoing, 10-year observational study by Takeda. These early results showed no overall association between Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug. At this time, the FDA’s review is ongoing. The agency has not concluded that Actos increases the risk of bladder cancer.
Avandia not implicated with same problem
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