In the wake of regulatory moves in France and Germany, the FDA has now spoken on the safety of Takeda Pharmaceutical's diabetes drug Actos. And the word is that using the drug for more than one year might boost the risk of bladder cancer.
Last week, French authorities suspended the drug, saying an official study found an increased risk of the disease in Actos patients. Germany followed with its own suspension, advising new patients not to start Actos therapy. Now, the FDA says Actos' U.S. labeling will be updated to include information about the bladder cancer risk, including warning against using Actos in patients with a history of that cancer.
The FDA says it's planning to review the French study, but the agency also is working off interim data from a 10-year safety study of Actos specifically designed to assess any risk of bladder cancer. Prompted by red flags in earlier trials, the 10-year study was ordered as a condition of Actos' approval in the U.S. And now, the 5-year data shows a greater likelihood of bladder cancer in patients who took the drug for the longest periods and at the highest cumulative doses, the agency says.
Takeda's stock fell on the news, which is something of a dramatic irony for Actos. The drug only recently took pole position in its class of diabetes drugs after rival Avandia was pulled in Europe and restricted in the U.S. on cardiac safety concerns. The company says that it's "confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes."