Amputation Risk of Invokana May Extend to Jardiance and Farxiga

Research confirmed by the FDA suggests the use of the diabetes drug Invokana can increase the risk of lower limb amputations. Now, a more recent study suggests that the risk of amputations may extend to other diabetes drugs in the same class, including Jardiance and Farxiga. The class of medications is known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. They work by blocking the actions of a protein in the body. Normally, the protein is responsible for reabsorbing sugar back into the body from the urine. By inhibiting the actions of the SGLT2 protein, the drugs enhance the removal of glucose from the body. However, the drugs have also been linked to serious, life-altering complications.

Overview of FDA Invokana warnings

The first SGLT2 inhibitor to enter the marketplace was Invokana, which was manufactured by Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals. A similar version, Invokamet, includes another active ingredient: Metformin. Just three years after Invokana was introduced, the FDA issued a safety communication that warned patients and doctors that it was possible there was an increased risk of leg and foot amputations when taking Invokana. Most of the recorded amputations affected the toes.

A year later, in May 2017, the FDA confirmed its findings. The FDA required the manufacturer to include the risk on the drug’s labeling information. At this time, the fact that other drugs in the same class had not been included in the FDA warning became a major selling point for those manufacturers. However, that didn’t last long.

New study challenges safety of other SGLT2 inhibitors

Swedish and Danish researchers evaluated data on over 17,000 patients who used Jardiance, Farxiga, and Invokana. The data were collected between July 2013 and December 2016 in patients from Sweden and Denmark. The researchers compared these data to that of patients who were on diabetes treatment plans, but with different drugs, including Onglyza, Victoza, and Byetta.

Their findings revealed that patients taking SGLT2 inhibitors had an increased risk of lower limb amputations that was more than twice the risk of the other patients. The SGLT2 inhibitor patient group also had more than twice the risk of diabetic ketoacidosis.

The research was published in the medical journal, The BMJ. In the study, the researchers did note that other factors can also increase the risk of lower limb amputations, such as peripheral arterial disease. The researchers stated that further studies were needed to assess whether the increased risk of amputation could be applicable to all SGLT2 inhibitor drugs, or whether it was confined to individual drugs.

Research and FDA warnings bolster SGLT2 inhibitor lawsuits

A number of patients have already filed Invokana lawsuits, and experts anticipate many more on the horizon. Legal claims have been filed with regard to a wide range of complications from SGLT2 inhibitors, including kidney failure and diabetic ketoacidosis. The amputation of toes, feet, and legs is another life-altering complication for which patients may seek compensatory damages. The Invokana lawsuits allege that the defendants failed to adequately warn patients and the medical community about these serious risks.

Additional resources:

1. MedicineNet, SGLT2 Inhibitors(Type 2 Diabetes Drug Class), https://www.medicinenet.com/sglt2_inhibitors_type_2_diabetes_drug_class/article.htm#what_are_sglt2_inhibitors?
2. The BMJ, Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study, https://www.bmj.com/content/363/bmj.k4365