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Amputation Risks & Invokana
Many people with type-2 diabetes develop a condition known as “diabetic foot.” Because diabetes destroys nerve endings in the feet and hardens blood vessels responsible for carrying blood to the toes, people with the condition can lose feeling in their feet. Invokana is a new kind of type-2 diabetes drug that forces the kidney to remove sugar from the body through urine. However, FDA studies have shown it also doubles the chances of a patient needing a foot or leg amputation.
Type 2 Diabetes Drug Linked to Amputation Risk
On May 18, 2016, the FDA issued a statement alerting the public about ongoing clinical trials that revealed an increased risk for leg and foot amputations in patients taking canagliflozin (Invokana®, Invokamet®, Invokamet® XR). At that time, they had not concluded that the type 2 diabetes medication was the culprit.
On May 16, 2017, after two large clinical trials, the FDA confirmed what many medical professionals had claimed: the drug does indeed increase the risk of foot and leg amputations. Most frequently, the toes and middle of the foot are affected.
Black Box Warning
In addition, the FDA has announced that a boxed warning must be added to drug labels alerting people of the risk. A boxed warning is the strictest warning label requirement issued by the FDA.