FDA warning of coma, death risk from high blood acid level complications from popular diabetes drugs

by Eric Pearson

The Food and Drug Administration has issued a warning about a risk of life-threatening complications in patients taking a new class of type 2 diabetes drugs. According to the FDA warning, patients taking drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors such as Invokamet, Xigduo XR, and Glyxambi may develop high blood acid levels that could lead to a coma or hospitalization.

SGLT2 inhibitors are designed to help the body remove blood sugar from the bloodstream of type 2 diabetes patients by inducing the kidneys to secrete this sugar through urine. SGLT2 inhibitors— including Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin), Jardiance (empagliflozin), and Glyxambi (empagliflozin and linagliptin)—have become popular in recent years because they have been shown to help increase weight loss and lower blood pressure in addition to helping lower blood sugar levels.

However, according to the FDA’s warning, patients taking SGLT2 inhibitors may develop ketoacidosis, a serious condition that occurs when the body produces high levels of blood acids known as ketones. According to data collected by the FDA, at least 20 cases of patients with diabetic ketoacidosis, ketoacidosis, or ketosis were reported by doctors between March 2013 and June 2014. The agency said that all of these patients required an emergency room visit or hospitalization in order to treat these complications. Since June 2014, the FDA says that it has continued to receive reports of patients who developed ketoacidosis after taking SGLT2 inhibitors.

The American Diabetes Association has stated that if patients who develop diabetic ketoacidosis do not receive proper treatment, the condition could lead to a diabetic coma or even death. Because of these health risks, the FDA is advising patients who are taking SGLT2 inhibitors to monitor themselves for symptoms of ketoacidosis, which may include difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue, or sleepiness. Patients who develop any of these signs of ketoacidosis should seek immediate medical attention if they experience any of these symptoms, the FDA has advised.

Industry analysts say that the FDA’s warning about the link between SGLT2 inhibitors and diabetic ketoacidosis could lead doctors to favor other oral diabetes medications as an alternative, such as Januvia and other drugs known as DPP4 inhibitors. Januvia, sold by Merck Inc., is the company’s best-selling drug with more than $6 billion in sales during 2014.

Victims of Side Effects from Dangerous Drugs Have Legal Rights

Far too often, the pharmaceutical industry puts its own profits ahead of the interests of patients, disregarding the safety of individuals who may use their products because of the enormous sales these drugs and medical devices may generate. Patients or family members whose lived ones have been injured as a result of side effects from dangerous drugs or medical devices may qualify to file a lawsuit and receive compensation for these injuries. The first step in determining whether you might qualify to take legal action is to talk with an attorney who is experienced in handling lawsuit involving serious injuries dangerous and defective drug.

The attorneys at Heygood, Orr & Pearson have filed many cases involving pharmaceutical liability and other personal injury cases. Our firm is AV-rated—the highest legal and ethical rating available—and all our partners Michael Heygood, Jim Orr, and Eric Pearson are all Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization. Mr. Heygood and Mr. Orr are also Board Certified in Civil Trial Advocacy Law by the National Board of Trial Advocacy. Our partners been voted by their peers as “Super Lawyers” in the state of Texas for several years in a row.*

At Heygood, Orr & Pearson, we believe that when the actions of drug companies and medical devices manufacturers compromise the health and safety of their patients, they should be held accountable in a court of law. Our attorneys have amassed years of trial experience on behalf of our clients, and will work diligently to ensure that you receive the best possible representation in your case.

For a free legal consultation and to learn more about filing a lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form on this site and answering a few simple questions to tell us more about your case.


* Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2015.

by Eric Pearson

Eric Pearson is a licensed attorney and a partner at HO&P who handles commercial and personal injury lawsuits. Eric has been selected to the Super Lawyers List, a Thomson Reuters publication.