Recently, the FDA has stated that taking the diabetes drugs Invokana or Invokamet may increase diabetes patients’ risk of leg and foot amputation.

These two brand-name drugs contain the medicine canagliflozin, a SGLT2 inhibitor used to lower blood sugar in people with type-2 diabetes, in conjunction with proper diet and exercise. Canagliflozin works by causing the kidneys to remove sugar from the blood, then excreting it in urine.

Two clinical trials of the effect of canagliflozin have shown that the drug may double a diabetes patient’s risk of Invokana amputation. The most common amputations required after patients took the drug were amputations of toes and the middle of the foot.

In some cases, patients required amputations of below and above the knee, and some patients even required multiple amputations as a result of their use of the drug.

As a result of this connection, in 2017, the FDA has required the makers of Inovkana and Invokamet to include a prominent “Boxed Warning” of the risk of Invokamet and Invokana amputation on the drug’s container. The FDA has stated that this type of warning is the most prominent side effect warning that a drug can have, stressing the extreme nature of this side effect.

The FDA warns that patients should be aware of the risks before taking these drugs, and patients who are already taking the drugs should inform themselves of the risks.

The FDA also urges patients to closely monitor their physical symptoms, and to contact their doctors right away if they develop new pain or tenderness in their lower extremities, sores or ulcers, or infections in their legs and feet. However, the FDA does instruct patients to not stop taking their diabetes medication without first consulting their doctor.

The FDA stresses that patients who are pre-disposed to needing amputations are at higher risk for Invokamet and Invokana amputation, and should be especially careful when taking canagliflozin. Patients who have peripheral vascular disease, neuropathy, or diabetic foot ulcers are especially susceptible to Invokamet and Invokana amputation.

Invokana Amputation Lawsuits

Lawyers are investigating if the makers of Invokamet and Invokana had knowledge of the risks of these drugs and their association with amputation before the 2017 studies. If the manufacturers did know of the risk and failed to properly warn patients and medical professionals, they may be liable for injuries to patients.

It is possible that the manufacturers failed to perform sufficient safety trials on the risks of the drugs, failed to sufficiently label the drug with warnings, or both. Or, they could have intentionally misrepresented the drug as safe when marketing it to patients and medical providers. If any of the situations are the case, patients would have had no way of knowing the associated risks.

If you have type-2 diabetes, took Invokamet or Invokana and had to have a lower-extremity amputation, filing a Invokamet and Invokana amputation lawsuit may help you get compensation for injuries.