Diabetes amputation causes may include type-2 diabetes treatment with medications including Invokana and Invokamet.

According to a study published in the journal BMJ by researchers at Karolinska University Hospital in Sweden, treatment with SGLT2 inhibitors Invokana and Invokamet may increase the risk of needing an amputation. The results showed that type-2 diabetes patients treated with Invokana and Invokamet were at an increased risk of needing a lower limb amputation, primarily affecting the toe or metatarsals.

The results of the study are alarming, as they indicate that diabetes amputation causes may include certain type-2 diabetes medications.

During the observational study, researchers examined registry data from Swedish and Danish health databases. The databases provided information of 21,008 new users of SGLT2 inhibitors and 27,278 new users of GLP1 receptor agonists, another type-2 diabetes medication.

In the SGLT2 inhibitor population, there were 2.7 lower limb amputation for every 1,000 patient years. In the GLP1 receptor agonist population, there were less than half of that with 1.1 amputations per 1,000 patient years.

Lead investigator Peter Ueda told TCTMD that clinical trials are the most reliable source for determining side effects of treatment and that the Karolinska’s observational study could be subject to confounding – meaning that the observed side effects could be attributed to the wrong cause.

“Our study adds to the data on the safety of these drugs by assessing the association between SGLT2 inhibitor use and serious adverse events in a substantially different population as compared to those included in the clinical trials, a population representative of routine clinical practice,” Ueda told TCTMD.

The study was published in November 2018 and reaffirms the conclusions of the CANVAS trials, a large scale study which identified Invokana and related medications as diabetes amputation causes.

Diabetes amputation causes may vary, but diabetic amputations often stem from diabetic ulcers which fail to heal correctly. Some consumers claim that Invokana’s effect on the kidneys diminishes the body’s ability to heal from wounds which increases the chance that diabetic ulcers will become deeply infected and lead to amputation.

Scientific studies and analysis have also linked SGLT2 inhibitors with a variety of other complications including diabetic ketoacidosis, acute kidney injury, and serious infections of the urinary tract. Although these complications can be detrimental to patient health, disabling amputations have lasting effects. Patients are often permanently disabled and are forced to make drastic lifestyle changes to compensate for their disability.

Because of the profound effects amputation can have, some consumers have taken legal action against drug manufacturers for allegedly concealing that Invokana and other drugs are among diabetes amputation causes. Some consumers argue that manufacturers knew or should have known that SGLT2 inhibitors are among diabetes amputation causes, but chose not to warn the public in order to protect their profits.

Regardless of manufacturer motivation, patients who are taking Invokana and other SGLT2 inhibitors should always consult with a doctor before making changes to their medications. Untreated diabetes can lead to life-threatening complications, so patients should not stop their medication without physician guidance.