A new study from Denmark and Sweden has found more evidence to support the association between Invokana and lower limb amputations. Writing in the British Medical Journal, researchers from the Nordic countries explain the results of their analysis of 34,426 patients. The researchers conclude that patients taking an SGLT2 inhibitor are more than twice as likely to undergo a lower limb amputation than patients taking other diabetes drugs.
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When they were released to the market, SGLT2 inhibitors were praised for their novel mechanism of action. SGLT2 inhibitors like Invokana reduce blood sugar levels by preventing the kidneys from reabsorbing glucose back into the blood. Instead, blood sugar is eliminated by the body through the urine, reducing overall glucose levels to treat type 2 diabetes.
Despite their promise, SGLT2 inhibitors have been linked to a host of severe side effects, including diabetic ketoacidosis, acute kidney injury, serious urinary tract infections and genital gangrene. One of the strongest risks, however, appears to be an increase in the risk for lower limb amputation.
Type 2 diabetes patients already live at an increased risk of lower limb amputations, but drugs like Invokana and Invokamet appear to cause a further jump in that risk. Building on prior research, a team of health scientists from Karolinska University Hospital, Statens Serum Institut and the University of Copenhagen add more evidence to support the association between Invokana, Invokamet, Farxiga and Jardiance and lower limb amputations.
The researchers used national data from health registry databases in Sweden and Denmark, assessing the health outcomes of two patient populations. The first group, comprised of 17,213 individuals, were all taking SGLT2 inhibitors. The second group, another 17,213 patients, were taking glucagon-like peptide 1 (GLP1) receptor agonists, another class of type 2 diabetes drugs. Analyzing the vast amount of health outcome data from these two groups, the team of researchers sought to analyze the frequency of adverse events.
SGLT2 inhibitor users tended to be older, were more likely to be men, less likely to be obese and less likely to use insulin. Among these patients, 61% used Farxiga, 38% used Jardiance and only 1% used Invokana. Even so, these drugs all work in basically the same way.
The data analyzed spanned from July 2013 to December 2016. GLP1 receptor agonists were chosen as the comparison group because they are used in similar clinical situations as SGLT2 inhibitors, but are not linked to any of the adverse events under consideration.
The researchers analyzed the incidence of numerous adverse health conditions, all of which have been linked to the use of SGLT2 inhibitors. "The primary outcome measures," they write, "were lower limb amputation, bone fracture, diabetic ketoacidosis, acute kidney injury, serious urinary tract infection, venous thromboembolism, and acute pancreatitis." As an additional outcome, the researchers considered amputations of the toe or metatarsal.
The patients taking SGLT2 inhibitors were more likely to undergo lower limb amputations and more likely to experience diabetic ketoacidosis, a life-threatening elevation in the level of blood acids. Where amputations are concerned, SGLT2 inhibitor patients were calculated to be 2.32-times more likely to undergo a lower limb amputation than GLP1 patients.
In addition, SGLT2 inhibitors were associated with a 55% increase in the risk for toe or metatarsal amputations.
This new study is likely to throw more fuel on the fire of recently-filed lawsuits, in which type 2 diabetes patients accuse Invokana's manufacturer, Janssen Pharmaceuticals, of concealing the drug's risks from the public. In legal documents, injured patients, many of whom have been forced to undergo leg, foot or toe amputations, say Janssen hid the risk from the medical community, leaving doctors without the vital information needed to make informed prescribing decisions.
Legal cases involving Invokana have been consolidated in the US District Court of New Jersey, where the Honorable Brian R. Martinotti has been selected to preside over the coordinated litigation. At present, Janssen Pharmaceuticals faces over 1,180 Invokana lawsuits, all of which have been centralized in the New Jersey federal court.
The cases are moving quickly, so injured patients should look to speak with an experienced attorney immediately. In the most recent news, Janssen Pharmaceuticals entered an undisclosed settlement agreement resolving all of the cases represented by Douglas & London, P.C., a plaintiffs' law firm in New York City. No word yet on whether or not Janssen intends to settle cases represented by other firms, or whether the litigation will head toward bellwether trials.