FDA Warns of Leg, Foot Amputations With Johnson & Johnson's Diabetes Med, Invokana
Johnson & Johnson is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday.
Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.
The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said.
Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.
The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said.