Safety Alerts & Recalls

What does this mean?

You should not stop or change your diabetes medicines without first talking to your healthcare provider. Stopping your diabetes medicine can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease.

This alert is a good reminder that people with diabetes should regularly check their legs, feet, and toes for unusual redness, sores, or tenderness. You should notify your healthcare provider right away if you notice any new pain or tenderness, sores or ulcers, or infections in your legs or feet.

Please follow up with your healthcare provider if you have any questions about this safety alert or your medicines.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website:

Clinical Trial Results Finds Increased Risk of Leg and Foot Amputations with Use of Canagliflozin (Invokana, Invokamet)

The U.S. Food and Drug Administration (FDA) has alerted the public about safety results reviewed at the mid-point of an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). The FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. The FDA is currently reviewing this new safety issue and will update the public when there is more information.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

For more information, please visit: more information here

Source: FDA
Publication Date: 2016-06-01
Last Updated: 2016-06-02

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