FDA warns of foot, leg amputations with Invokana
On Tuesday, the Food and Drug Administration required Johnson & Johnson to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations.
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.
Invokana is already the subject of litigation that alleges it causes severe kidney damage including diabetic ketoacidosis.
Invokana belongs to a relatively new class of type 2 diabetes drugs called SGLT-2 inhibitors, which help remove excess blood sugar through urine. Others in the class include Eli Lilly and Co's (LLY.N) Jardiance and AstraZeneca Plc's (AZN.L) Farxiga.