After reviewing the data from three clinical trials, the FDA has removed the warning regarding the risk of leg and foot amputations with canagliflozin.
Canagliflozin — found under the brand names Invokana, Invokamet and Invokamet XR — is a medication approved to lower blood sugar in adults with type 2 diabetes (in combination with diet and exercise).
This warning was added in 2017 after an assessment revealed the risk of leg and foot amputations was serious when compared to the benefits of the medication.
Over the last few years, canagliflozin has been approved for additional uses. For example, this drug was approved to lower the risk of major heart-related events, such as heart attack, stroke or death, in those with type 2 diabetes who have known heart disease.
Later, canagliflozin was approved to lower the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and hospitalizations due to heart failure in certain people with type 2 diabetes and kidney disease related to diabetes.
These new approvals increased the benefits of this drug, the FDA noted.
And data from recent clinical trials showed that the risk of leg and foot amputations was actually lower than previously listed. Although the risk was still increased with this drug, it was lower especially when patients were monitored.
As a result, the FDA removed canagliflozin's boxed warning about the risk of leg and foot amputations.
However, amputation is still a possibility; that's why this risk will still be listed in the Warnings and Precautions section.
When taking this medication, take preventive foot care measures and monitor for changes in your legs and feet. These changes may include but are not limited to new pain, tenderness, sores, ulcers and infections.
Experts recommend checking your feet every day. Set up a time to do so daily. Check for calluses, sores, cuts, red spots, blisters and swelling. If it is hard to reach your feet, try using a mirror to see the bottoms of your feet. Furthermore, ask your primary care provider to check your feet at every visit.
Other tips to help keep your feet healthy include the following:
- Make an appointment with a podiatrist. Experts recommend scheduling a foot exam with a podiatrist once a year.
- Wash your feet every day. Dry your feet well with a soft towel, especially in between the toes. Test the water with your hands first to make sure the water is not too hot.
- Wear the right shoes. Avoid wearing shoes that are too tight or too loose.
- Apply lotion to keep the skin of your feet soft and smooth. Avoid applying lotion between the toes because wetness between the toes can result in fungal infections.
Speak with your health care provider if you have any questions.