Amputation is a concern for patients contending with this disease, according to WebMD, as it can greatly interfere with the body’s natural circulation process and cause lower limb neuropathy.

However, the FDA has recently warned that patients may face a greater risk lower limb amputation if they are prescribed canagliflozin based medications Invokana, Invokamet, or Invokamet XR.

The FDA issued a warning regarding type-2 diabetes and amputation on May 16, 2017. The warning stated that “based on new data from two large clinical trials” there could be an increased risk of leg and foot amputations with canagliflozin treatment drugs.

One of the two recent inquiries that prompted the warning was the CANVAS study, which reportedly found that the medications more than doubled the risk of lower limb amputations compared to the placebo group.

The FDA had originally mandated this study to observe potential cardiovascular complications the drug could potentially cause, which revealed the amputation problem. The findings had prompted the FDA to order a black box warning, which has spurred major concern in the medical community.

According to a report by Medpage Today, some doctors have already started switching their patients to a different type-2 diabetes treatment drugs, since these patients are already at an increased risk for lower limb amputation.

Overview of Type-2 Diabetes Amputation

Type-2 diabetes and amputation are constant concerns for patients living with this condition

According to Verywell Health, these patients have to deal with a variety of biological interference from the disease.

Poor circulation and blood vessels narrowing are among these concerns, especially in the legs and feet. Commonly, type-2 diabetes patients experience nerve death or neuropathy in their legs due to poor circulation.

Nerve death can cause fluid retention to buildup and ulcers to form, which greatly interferes with movement. The condition can eventually cause the need for lower limb amputation — ranging from a single toe to the entire portion below the knee being removed depending on the severity of the patient’s condition.

According to Medpage Today, physicians in San Diego working for the Sharp HealthCare hospital group have started monitoring patients on cangliflozin medications like Invokana and Invokamet after reviewing the FDA’s warning. Kaiser Permanente has started monitoring patients in California, further scrutinizing their medical records for any sign lower limb ulcers or neuropathy.

Other physicians have taken a more aggressive approach to the matter, according to Medpage Today, calling patients to discuss their medication options after they reviewed the FDA warning.

Even though the FDA warning has spurred major concern in the medical community, Janssen Pharmaceuticals maintains canagliflozin is a safe medication and the company continues to tout its benefits for type-2 diabetes patients, such as lowering the risk of cardiac complications.

The Medpage article notes that, while the CANVAS study found an increased risk, scientists have been unable to determine why the lower limb amputations have been occurring. In addition, some doctors have stated the amputation risk is more likely higher in patients who have had a history of lower limb amputation or have a preexisting circulation condition, like peripheral vascular disease.

With this in mind, not all doctors are worried over the FDA’s warning and are continuing to prescribe canagliflozin medications like Invokana and Invokamet, notes Medpage.

Type-2 diabetes patients are currently being advised to follow healthy living habits, and stick to their treatment regimen instructions to minimize the chances of diabetic complications.