What's more worrisome for a drug than potential cardiovascular side effects? Cancer concerns. And that's just what's happened for Takeda Pharmaceutical's diabetes drug Actos. The FDA says it's reviewing data for a potential link to bladder cancer.
This news comes as the agency is also reviewing Actos' chief competitor Avandia, which has been linked to a variety of cardiovascular problems, including heart attack and stroke. The FDA's expert advisors recently debated the safety data on that drug, made by GlaxoSmithKline, but delivered a mixed opinion. A majority voted for new warnings and/or restrictions, but a solid minority recommended withdrawal.
As the Washington Post points out, Actos had drawn business away from Avandia because it was seen as--and touted by Takeda as--safer than its rival. Indeed, some experts have cited Actos' superior safety profile as support for pulling Avandia off the market; if the GSK drug were gone, the safer Takeda version would still be available, or so the theory went.
The FDA's review of Actos is in early stages, and a cancer link may not prove out. The early data shows that overall incidence of bladder cancer didn't increase in Actos patients, but those who had used the drug longest--and those with the highest cumulative doses of the drug--did show an increased risk. And just in case you were wondering, FDA says there's no data supporting bladder-cancer risk for Avandia.