The FDA has released a drug safety report stating that two large clinical trials have indicated that a class of type-2 diabetes treatment drugs known as SGLT2 inhibitors may be linked to an increased risk of lower limb amputation.

FDA SGLT2 Drugs Warning

According to a drug safety communication released by the FDA in 2017, the type-2 diabetes medication canagliflozin, an SGLT2 inhibitor used in the brand-name drugs Invokana, Invokamet, and Invokamet XR, is associated with an increased risk of amputation.

Amputations associated with these drugs are often of the toes or feet, as well as amputations of the leg above and below the knee. The FDA stated that they will require a warning about these risks to be added to the labels and prescribing information for these drugs.

The clinical trials cited in the FDA report include CANVAS, or the 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. According to these studies, patients who were prescribed canagliflozin were as much as twice as likely to experience an amputation as patients who were treated with inactive placebo medication. Almost 6 out of every 1,000 patients who took canagliflozin required an amputation.

What Are SGLT2 Inhibitors?

Sodium-glucose cotransporter-2 inhibitors, or SGLT2 medicines, are a class of type-2 diabetes drug meant to help control blood sugar levels in adults. According to the FDA page for SGLT2 inhibitors, these medicines lower blood sugar by causing the kidneys to filter sugar out from the body through urine. The drugs block proteins that reabsorb glucose, leaving the glucose to be filtered out of the body as a waste product.

Dangers of SGLT2 Inhibitors

Aside from the increased risk of amputations, Invokana, Invokamet, and Invokamet XR have many other possible side effects. While some of these side effects are common and low risk, some of them are extremely dangerous. These side effects include:

• Ketoacidosis, a serious condition caused by increased ketones in the blood or urine. Symptoms may include nausea, vomiting, stomach pain, or trouble breathing.
• Necrotizing fasciitis of the perineum, a rare but serious bacterial infection that may lead to hospitalization, surgeries, skin grafts, or death.
• Kidney problems, including sudden kidney injury.
• Yeast infections.
• Increased potassium levels.
• Serious urinary tract infections.
• Increased risk of bone fracture.
• Low blood sugar (hypoglycemia).
• Dehydration

Invokana and Invokamet Lawsuits

Many lawsuits and investigations have been initiated regarding the possibility of dangerous side effects associated with SGLT2 inhibitors. If you or a loved one have been prescribed Invokana, Invokamet, Invokamet XR, or another SGLT2 inhibitor for type-2 diabetes treatment and have suffered injuries including amputation or other side effects, you may qualify to join an SGLT2 investigation or lawsuit at no cost to you.