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Medication Safety Alerts

Canagliflozin Black Box Warning

5/16/2017

On May 16, 2017, the United States Food and Drug Administration (FDA) issued a MedWatch to announce they are requiring new warnings to be added to the canagliflozin drug labels about an increased risk of leg and foot amputations.

Plan members taking canagliflozin should notify their doctor right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet. Talk to your doctor if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your doctor.

The FDA has provided the following information for members taking canagliflozin:

  • The type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) can increase your risk of leg and foot amputations. This risk may be higher for some people, including those who have peripheral vascular disease, neuropathy (nerve damage), or diabetic foot ulcers (sores), or who have a history of prior amputation.
  • Contact your doctor right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet.
  • Your doctor may determine it is appropriate for you to stop taking canagliflozin in these situations.
  • Do not stop or change your diabetes medicines without first talking to your doctor. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, uncontrolled blood sugar levels can cause serious problems, including blindness, nerve and kidney damage, and heart disease.
  • Read the patient Medication Guide every time you receive a canagliflozin prescription because the information might change. The Medication Guide explains the benefits and risks associated with the medicine.
  • Talk to your doctor if you have questions or concerns about canagliflozin or any other diabetes medicines.
  • Report side effects from canagliflozin or other medicines to the FDA

A complete list of the products affected by this issue is provided here :

CVS Caremark Response: Please note: There have been no recalls issued on this product because of this action. CVS Caremark Mail Service Pharmacy will continue to dispense canagliflozin.

If you are currently taking canagliflozin and have questions, please call your doctor or call the FDA consumer inquiry line toll-free at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov .

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