The FDA has issued a box warning saying that the diabetes medication Invokana may increase patients’ risk of needing amputation.

People with diabetes are already more likely to need a lower-limb amputation than the general public, because the disease can damage the circulatory system, preventing blood from getting to the lower extremities.

Unfortunately, some drugs designed to help people manage their type-2 diabetes have been found to increase the risk of amputations in people with diabetes, not lower it. One of these drugs is called canagliflozin, known by its brand name Invokana. When the drug is in combination with metformin, it is called Invokamet. The diabetes medication Invokana has been tied to serious risks. 

Canagliflozin is one of a class of diabetes medications called sodium glucose co-transporter-2 (SGLT2) inhibitors, which help manage diabetes by targeting the protein responsible for reabsorbing glucose in the kidneys and renal system, thereby causing excess sugar to be expelled in the urine.

Drugs that may increase diabetes’ patients risk of needing an amputation include:

• Invokana (canagliflozin)
• Invokamet (canagliflozin metformin)
• Invokamet XR (canagliflozin and metformin hydrochloride extended-release)
• Invokana and Amputation

Invokana and Amputation

According to a warning issued by the Food and Drug Administration in May of last year, people taking the diabetes medication Invokana were twice as likely to suffer a lower limb amputation than people taking a placebo. This warning follows up on a safety alert that the FDA released on May 18, 2016.

This information reportedly comes from two trials conducted that compared Invoking to placebo drugs. According to the studies, amputations of the toe and middle of the foot were the most common forms of amputation needed, but in some cases, larger parts of the leg, both above and below the knee had to be removed.

The studies suggested that patients who had had prior amputations were at a higher risk of requiring amputations in connection with their use of the diabetes medication Invokana. Other patients who have a higher risk of needing an amputation after using Invokana are those with peripheral vascular disease, neuropathy (nerve damage), or diabetic foot ulcers (sores).

As a result of the FDA’s warning, the boxes for canagliflozin are now required to bear a warning of the amputation risks associated with the drug.

The FDA warned patients taking canagliflozin, otherwise known as the diabetes medication Invokana of the following:

“Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns.” The FDA also warned patients that they should not stop taking the diabetes medication Invokana without first talking to their health care professional.

Diabetes Medication Invokana Lawsuit Investigation

It is possible that the makers of Invokana knew that the drug could cause people to lose limbs, and marketed it nonetheless. Drug makers have a duty to notify patients of the risks associated with taking a drug, and may be held accountable for patient injury if they fail to do so.

Now lawyers are looking for patients who have suffered amputations after taking Invokana or Invokamet for an Invokana lawsuit investigation. Filing a valid claim could help you gain compensation for the injury you suffered from taking the diabetes medication Invokana.