FDA Asks for Actos Bladder Cancer Warning

Washington, DCThe one-time benefactor of the strife afflicting Avandia is having troubles of its own, now that the US Food and Drug Administration (FDA) has postulated that Actos is in need of a warning pertaining to the risk for bladder cancer—especially if the Type 2 diabetes drug is used for longer than a year.

Diabetes, once diagnosed, is usually a life-long affliction requiring constant medication to control. Actos, manufactured by Takeda Pharmaceuticals, picked up where Avandia left off after the GlaxoSmithKline diabetes drug was castigated for heart risk and other adverse reactions.

At most, Actos was considered safer—or at worst, considered no worse itself, than Avandia. Doctors switched their patients to Actos in droves, and sales of the Takeda drug soared to about $5 billion worldwide at current levels.

Analysts now ponder the impact of sales on Actos with this latest FDA announcement.

It should be noted that the FDA response pales in comparison to action taken by health regulators in France and Germany. According to a June 16 Reuters report, the two countries have suspended sales of Actos entirely.

The FDA, apparently, is not prepared to do that here. In fact, the response of the US health regulator is viewed as somewhat anemic, according to one analyst.

"The FDA's action is extremely mild, when compared with the measures taken by France or Germany," said Jefferies analyst Naomi Kumagai, in comments published in Reuters this morning. "The FDA is not taking Actos off the shelves or asking doctors to stop prescribing it. It is merely telling professionals to inform patients of the risk-benefit balance.

"This on its own will not have an immediate impact on sales. Still, it is certainly not a positive," she said.

To that end, shares of Japan-based Takeda Pharmaceutical Co. have fallen, losing 1.1 percent at the close of trading yesterday. This morning, Takeda was down 0.9 percent when the Nikkei opened overnight.

Actos is the subject of an ongoing, decade-long study by the FDA. The health regulator said that so far Actos has not led to an increased risk of bladder cancer in their study overall. But that finding does not suggest it can't happen. In fact, the impetus of the FDA warning appears to stem from patients having the highest cumulative dose of Actos as presenting with an increased risk of bladder cancer.

Hence, the request for a warning.

Reuters is reporting that Actos is under review by the European Medicines Agency. Its findings and response could have an impact on the FDA's long-term position on Actos. For now, the FDA review of Actos is continuing, together with a request for a warning—presumably a black box warning—with regard to the risk for bladder cancer in patients with cumulative high doses (Actos use for longer than a year).

At this juncture, the FDA has only the power to ask for a warning. Takeda responded that it intends to carry out the FDA's request ahead of its patent expiry for Actos in 2012.