FDA Removes Boxed Warning About Risk of Leg and Foot Amputations for Canagliflozin (Invokana®)
August 26, 2020
Background
Canagliflozin belongs to a class of medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is used in patients with Type 2 Diabetes to lower blood glucose.
| Date | Action |
|---|---|
| 2013 | FDA approves canagliflozin for the treatment of Type 2 Diabetes. |
| 2017 | A Boxed Warning that canagliflozin may increase the risk of leg and foot amputation is added to the package insert. |
| 2018 | Canagliflozin is approved by the FDA to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease. |
| 2019 | Canagliflozin is approved by the FDA to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease. |
| 2020 | FDA removes Boxed Warning about risk of leg and foot amputations for canagliflozin:
|
Recommendation
Although the Boxed Warning will be removed, there is still an increased risk of leg and foot amputations. Healthcare professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines.
Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).
Instructions for reporting can be found online at the NPTC Pharmacovigilance website.
