Product News and Recalls

Diabetic Ketoacidosis Connection Remains despite SGLT2 Inhibitor Trial Results

A recent Reuters article reports that Eli Lilly & Co. and Boehringer Ingelheim have received positive results for their sodium-glucose cotransporter-2 (SGLT2) inhibitor Jardiance. According to a recent drug trial, empagliflozin (Jardiance) can cut patients’ risk of cardiovascular problems like heart attack and stroke. But Jardiance and other SGLT2 inhibitors still cannot seem to escape the shadow of diabetic ketoacidosis, a potentially fatal blood condition to which the new class of diabetes drugs has been linked.

SGLT2 inhibitors had not been on the market two years before the U.S. Food and Drug Administration (FDA) released a safety communication connecting drugs like Jardiance, Invokana, and Farxiga to diabetic ketoacidosis. In the ensuing months, reports surfaced suggesting SGLT2 inhibitors, in addition to possibly causing ketoacidosis, may also be contributing to delayed or incorrect diagnosis of the same condition. While companies like Eli Lilly and Janssen Pharmaceutica tout the weight-loss and blood pressure–reduction (and now cardiovascular health) benefits of their drugs, medical experts are still trying to understand their immediate metabolic and humoral effects.

According to Reuters, Lilly and Boehringer’s results come from the EMPA-REG OUTCOME trial, a 7,000-patient study of type 2 diabetes patients considered to be at risk of cardiovascular problems. Fewer fatal and non-fatal heart attacks and strokes were observed in patients who took Jardiance.

For now, medical experts and pharmaceutical investors are taking the results with a grain of salt, as they do any industry-sponsored study. The FDA and Health Canada are reviewing data on these drugs are expected to weigh in about the current risk/benefit profile.

The FDA previously expressed concern about another large ongoing trial (dubbed “CANVA”S) in which an increased in cardiovascular events was noted in the first 30 days. It remains to be seen how patients fared at the start of this new trial. The full results are expected to be released on September 17 at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

Talk to your doctor if you have any medical concerns about the drugs you are taking. If you or someone close to you was diagnosed with diabetic ketoacidosis after using an SGLT2 inhibitor like Jardiance or Invokana, contact the pharmaceutical attorneys at Lopez McHugh today to receive your free legal consultation. You may be entitled to compensation through an SGLT2 inhibitor lawsuit.