A safety communication issued by the U.S. Food and Drug Administration (FDA) indicates that diabetes medication Invokana may have a role in an increased rate of toe and foot amputations among diabetes patients.

Diabetes medication Invokana is a prescription type-2 diabetes drug that is in the sodium-glucose cotransporter-2 (SGLT2) inhibitor class. Other drugs in this class include Invokamet (canagliflozin metformin and Invokamet XR (canagliflozin and metformin hydrochloride extended-release).

Type-2 diabetes medication Invokana is supposed to lower blood sugar in adults when coupled with a healthy diet and exercise. The way it does this is by causing the kidneys to remove sugar from the blood through the urine.

Invokana Users May Run Risk of Amputation

According to A Sweet Life, a diabetes informational website, the risks of type-2 diabetes medication Invokana may outweigh the benefits. Even though type-2 diabetes medication Invokana has been seen to have great benefits for diabetes sufferers, it may also contribute to some pretty serious health complications.

The FDA reports about the findings of two different clinical trials, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus).

These studies reportedly showed that in those patients who were treated with type-2 diabetes medication Invokana and similar drugs, the incidence of leg and toe amputations occurred in about twice as many patients than those treated with a placebo.

According to the FDA, “The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to 5.9 out of every 1,000 patients treated with canagliflozin [and] 2.8 out of every 1,000 patients treated with placebo.”

Additionally, “The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to 7.5 out of every 1,000 patients treated with canagliflozin [and] 4.2 out of every 1,000 patients treated with placebo.”

The FDA says that among these amputations, amputations of the middle of the foot and the toe were the most commonly reported. But there were times, the FDA notes, that patients taking type-2 diabetes medication Invokana had to have parts of their legs amputated, both above and below the knees.

This risk was great enough for the FDA to issue a black box warning for diabetes medication Invokana regarding lower limb amputation.

Other Diabetes Medication Invokana Side Effects

There are other serious side effects associated with diabetes medication Invokana aside from the risk of lower limb amputations. These other side effects include the possibility of ketoacidosis, a serious condition in which there is increased acidity in the body.

Those who suffer from ketoacidosis as a result of taking type-2 diabetes medication Invokana may have higher levels of ketones in the body and may experience difficulty breathing, abdominal pain, nausea, vomiting, onfusion or unusual levels of fatigue.

Do not discontinue taking type-2 diabetes medication Invokana without speaking to your physician. However, if you have experienced a lower limb amputation while taking Invokana, you may also benefit from speaking with an experienced attorney.