The federal Food and Drug Administration (FDA) announced Friday that it is reviewing Takeda Pharmaceuticals’ diabetes drug Actos due to concerns that the drug increases the risk of bladder cancer in patients who take it over a long period of time. Actos, along with the similar diabetes drug Avandia made by GlaxoSmithKline, has previously been linked to heart disease, heart attack, and heart failure but was left on the market by FDA with new labeling requirements.
Concerns over conflicts-of-interest in previous reviews of Actos may lead to increased scrutiny of the FDA’s deliberations on the risks of Actos and Avandia. During previous reviews of Actos, FDA panel members have revealed financial relationships with Takeda Pharmaceuticals and rival GlaxoSmithKline, causing some to question the panels’ independence.
The FDA has not yet concluded that Actos definitely increases the risk of bladder cancer and says that patients currently taking Actos should not stop taking their medication, but should speak to their doctor about any concerns they have about dangerous side effects.